Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT03553927
Status:
COMPLETED
Last Update Posted:
2024-11-07
First Post:
2018-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Investigating the Physiological Effects of Weight Loss on Male Fertility
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D031204', 'term': 'Caloric Restriction'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002149', 'term': 'Energy Intake'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'c.jayasena@imperial.ac.uk', 'phone': '02083833242', 'title': 'Channa Jayasena', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'description': 'Adverse events were monitored for as defined as per clinicaltrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sperm Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'OG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}], 'classes': [{'title': 'Study A (men with normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.6', 'spread': '36.4', 'groupId': 'OG000'}, {'value': '58.5', 'spread': '32.8', 'groupId': 'OG001'}]}]}, {'title': 'Study B (men with low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.1', 'spread': '59.16', 'groupId': 'OG000'}, {'value': '15', 'spread': '16.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'The number of sperm per millimeter of semen. Sperm concentration is an important factor affecting male fertility. It is calculated on a standard semen analysis', 'unitOfMeasure': 'million sperms/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed refers to the total number after combining the two sub-studies'}, {'type': 'SECONDARY', 'title': 'Total Motility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'OG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}], 'classes': [{'title': 'men with a normal sperm concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.5', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '60.8', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'men with a low sperm concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.9', 'spread': '12', 'groupId': 'OG000'}, {'value': '45.4', 'spread': '16.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Total motility refers to the percentage of sperm making any sort of movement.', 'unitOfMeasure': 'percentage of sperm that is motile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed refers to the total number after combining the two sub-studies.\n\nSome participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure total motility.'}, {'type': 'SECONDARY', 'title': 'Progressive Motility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'OG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}], 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.3', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '53.9', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.8', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'This type of motility refers to sperm that swim progressively, mostly in a straight line or large circles.', 'unitOfMeasure': 'percentage of progressively motile sperm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed refers to the total number after combining the two sub-studies.\n\nSome participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure progressive motility.'}, {'type': 'SECONDARY', 'title': 'DNA Fragmentation Index (DFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'OG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}], 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Percentage of sperm with fragmented DNA', 'unitOfMeasure': 'Percentage of sperm with fragmented DNA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed refers to the total number after combining the two sub-studies.\n\nSome participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure DNA fragmentation index.'}, {'type': 'SECONDARY', 'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Energy Diet, Men With Normal Sperm Concentration', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'OG001', 'title': 'NHS Advice on Healthy Eating, Men With Normal Sperm Concentration', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}], 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.6', 'spread': '5', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Testosterone is the primary androgen in men and is synthesized in the testes. It can be measured in the serum.', 'unitOfMeasure': 'nmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed refers to the total number after combining the two sub-studies.\n\nOne participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample.'}, {'type': 'SECONDARY', 'title': 'Sex Hormone-Binding Globulin (SHBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'OG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}], 'classes': [{'title': '(men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.2', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': 'study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.2', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '22.6', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'SHBG is a protein that is produced by the liver and binds tightly to the hormones testosterone, dihydrotestosterone (DHT) and oestradiol, and transports them in the blood in an inactive form.', 'unitOfMeasure': 'nmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed refers to the total number after combining the two sub-studies.\n\nOne participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample.'}, {'type': 'SECONDARY', 'title': 'Reactive Oxygen Species (ROS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'OG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '39.1'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '37.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '16 weeks', 'description': 'ROS is measured by oxidative colour change of luminol per second per million sperm.', 'unitOfMeasure': 'RLU/sec/million sperm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ROS was only measured in Study B. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure ROS.'}, {'type': 'SECONDARY', 'title': 'Morphology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'OG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}], 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'the percentage of sperm that appear normal when semen is viewed under a microscope', 'unitOfMeasure': 'percentage of sperm of normal morphology', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed refers to the total number after combining the two sub-studies.\n\nSome participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure morphology.'}, {'type': 'SECONDARY', 'title': 'Luteinizing Hormone (LH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'OG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}], 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'LH produced in the pituitary gland, stimulates the leydig cells in the testes to produce testosterone.', 'unitOfMeasure': 'IU/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed refers to the total number after combining the two sub-studies.\n\nOne participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample.'}, {'type': 'SECONDARY', 'title': 'Follicle Stimulating Hormone (FSH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'OG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}], 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'FSH produced in the pituitary gland, stimulates the testes to produce mature sperm.', 'unitOfMeasure': 'IU/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed refers to the total number after combining the two sub-studies.\n\nOne participant in Low Energy Diet arm in study B did not have this measurement due to insufficient sample.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'FG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}], 'periods': [{'title': 'Study A (Men With a Normal Sperm Conc.)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Study B (Men With a Low Sperm Conc.)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Energy Diet', 'description': 'Commercially available diet products\n\nLow Energy Diet: Caloric restriction to achieve weight loss'}, {'id': 'BG001', 'title': 'NHS Advice on Healthy Eating', 'description': 'Dietary / lifestyle advice programme\n\nNHS advice on healthy eating: Advice on energy requirements as per the British Dietetic Association'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.2', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '39.4', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '39.8', 'spread': '8', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37.7', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '39.5', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '38.6', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Mixed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Arab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '109.5', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '114.1', 'spread': '11', 'groupId': 'BG001'}, {'value': '112.6', 'spread': '11.4', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '116.8', 'spread': '17.3', 'groupId': 'BG000'}, {'value': '117', 'spread': '21.9', 'groupId': 'BG001'}, {'value': '116.9', 'spread': '19.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}, {'title': 'Waist circumference', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '117.3', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '119.5', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '118.8', 'spread': '8.4', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '123.4', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '120.9', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '122.1', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimetres', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}, {'title': 'Sperm concentration', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.3', 'spread': '15', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '21.3', 'groupId': 'BG001'}, {'value': '46.2', 'spread': '19.8', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '9.8', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '7.6', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'million sperms/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}, {'title': 'Semen volume', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '3.9', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '3.6', 'spread': '1.3', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '3.3', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}, {'title': 'Progressive motility', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41', 'spread': '16', 'groupId': 'BG000'}, {'value': '45', 'spread': '8', 'groupId': 'BG001'}, {'value': '43', 'spread': '12', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.7', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '33.4', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '31.1', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This type of motility refers to sperm that swim progressively, mostly in a straight line or large circles', 'unitOfMeasure': 'percentage of progressively motile sperm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies.\n\nSome participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure progressive motility.'}, {'title': 'Total motility', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'spread': '17', 'groupId': 'BG000'}, {'value': '52', 'spread': '8', 'groupId': 'BG001'}, {'value': '50', 'spread': '13', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '40', 'spread': '15.5', 'groupId': 'BG001'}, {'value': '36', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total motility refers to the percentage of sperm making any sort of movement.', 'unitOfMeasure': 'percentage of sperm that is motile', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies.\n\nSome participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure total motility.'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35.3', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '36.2', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '35.8', 'spread': '3.3', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38', 'spread': '4', 'groupId': 'BG000'}, {'value': '38', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '38', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}, {'title': 'DNA Fragmentation Index', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '15.9', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '13.8', 'spread': '9.5', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '12.1', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '13.6', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Percentage of sperm with fragmented DNA', 'unitOfMeasure': 'percentage of sperm with fragmented DNA', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure DNA Fragmentation Index..'}, {'title': 'Testosterone', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.7', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '12.3', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '12.5', 'spread': '3.4', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '14.6', 'spread': '5', 'groupId': 'BG001'}, {'value': '13.4', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nmol/l', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}, {'title': 'Sex hormone-binding globulin (SHBG)', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.8', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '25.2', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '23.5', 'spread': '8.4', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.4', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '24.8', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '23.2', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nmol/l', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}, {'title': 'Reactive oxygen species (ROS)', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'BG000', 'lowerLimit': '5.5', 'upperLimit': '177'}, {'value': '3.6', 'groupId': 'BG001', 'lowerLimit': '1.2', 'upperLimit': '37'}, {'value': '7.1', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'description': 'ROS is measured by oxidative colour change of luminol per second per million sperm', 'unitOfMeasure': 'RLU/sec/million sperm', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'ROS was only measured in Study B. Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to measure ROS.\n\n.'}, {'title': 'Morphology', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '1.8', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '1.3', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '1', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '0.7', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'the percentage (%) of sperm that appear normal when semen is viewed under a microscope.', 'unitOfMeasure': 'percentage of sperm of normal morphology', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Some participants in Study B were not assessed for this measure due to sperm concentrations that were too low to analyze morphology.'}, {'title': 'Luteinizing Hormone (LH)', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '1', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '3.3', 'spread': '1.4', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '4', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'IU/l', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}, {'title': 'Follicle Stimulating Hormone (FSH)', 'classes': [{'title': 'Study A (men with a normal sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '4.4', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '4.3', 'spread': '2.8', 'groupId': 'BG002'}]}]}, {'title': 'Study B (men with a low sperm concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '5', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'IU/l', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}], 'populationDescription': 'The overall number of baseline participants refers to the total number after combining the two sub-studies'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-09', 'size': 1379616, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-08T10:12', 'hasProtocol': True}, {'date': '2020-01-14', 'size': 245730, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-01-08T10:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 sub-studies Study A (men with a normal sperm concentration) Study B (men with a low sperm concentration)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2018-05-31', 'resultsFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2018-05-31', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-06', 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sperm Concentration', 'timeFrame': '16 weeks', 'description': 'The number of sperm per millimeter of semen. Sperm concentration is an important factor affecting male fertility. It is calculated on a standard semen analysis'}], 'secondaryOutcomes': [{'measure': 'Total Motility', 'timeFrame': '16 weeks', 'description': 'Total motility refers to the percentage of sperm making any sort of movement.'}, {'measure': 'Progressive Motility', 'timeFrame': '16 weeks', 'description': 'This type of motility refers to sperm that swim progressively, mostly in a straight line or large circles.'}, {'measure': 'DNA Fragmentation Index (DFI)', 'timeFrame': '16 weeks', 'description': 'Percentage of sperm with fragmented DNA'}, {'measure': 'Testosterone', 'timeFrame': '16 weeks', 'description': 'Testosterone is the primary androgen in men and is synthesized in the testes. It can be measured in the serum.'}, {'measure': 'Sex Hormone-Binding Globulin (SHBG)', 'timeFrame': '16 weeks', 'description': 'SHBG is a protein that is produced by the liver and binds tightly to the hormones testosterone, dihydrotestosterone (DHT) and oestradiol, and transports them in the blood in an inactive form.'}, {'measure': 'Reactive Oxygen Species (ROS)', 'timeFrame': '16 weeks', 'description': 'ROS is measured by oxidative colour change of luminol per second per million sperm.'}, {'measure': 'Morphology', 'timeFrame': '16 weeks', 'description': 'the percentage of sperm that appear normal when semen is viewed under a microscope'}, {'measure': 'Luteinizing Hormone (LH)', 'timeFrame': '16 weeks', 'description': 'LH produced in the pituitary gland, stimulates the leydig cells in the testes to produce testosterone.'}, {'measure': 'Follicle Stimulating Hormone (FSH)', 'timeFrame': '16 weeks', 'description': 'FSH produced in the pituitary gland, stimulates the testes to produce mature sperm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Male Infertility', 'Obesity'], 'conditions': ['Male Infertility', 'Obesity', 'Weight Loss']}, 'referencesModule': {'references': [{'pmid': '23242914', 'type': 'BACKGROUND', 'citation': 'Sermondade N, Faure C, Fezeu L, Shayeb AG, Bonde JP, Jensen TK, Van Wely M, Cao J, Martini AC, Eskandar M, Chavarro JE, Koloszar S, Twigt JM, Ramlau-Hansen CH, Borges E Jr, Lotti F, Steegers-Theunissen RP, Zorn B, Polotsky AJ, La Vignera S, Eskenazi B, Tremellen K, Magnusdottir EV, Fejes I, Hercberg S, Levy R, Czernichow S. BMI in relation to sperm count: an updated systematic review and collaborative meta-analysis. Hum Reprod Update. 2013 May-Jun;19(3):221-31. doi: 10.1093/humupd/dms050. Epub 2012 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the physiological effects of weight loss on seminal parameters in male participants with reduced reproductive capacity. Learning more about the physiological role of weight loss on reproductive function and metabolic profile of overweight and obese men may give us a better understanding of male fertility and improve the management of patients with reduced fertility. The effects of weight loss on seminal quality are not well understood.', 'detailedDescription': 'Participants will receive dietary supplements or National Health Service (NHS) advice on healthy eating to achieve weight loss.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) ≥ 30 kg/m\\^2 \\[Part: 1, 2\\& 3\\]\n* Evidence of reduced reproductive capacity (e.g. reduced sperm concentration \\[applicable for study B\\]\n\nExclusion Criteria:\n\n* History of undescended testes, testicular surgery or mumps infection\n* Hormonal therapy such as testosterone or selective oestrogen receptor modulators\n* History of systemic cytotoxic therapy or pelvic radiotherapy\n* Chronic systemic disease, such as cardiac, renal or liver failure\n* At least one of the following:\n\nAlcohol intake \\>30 units per week Smoking daily Recreational drug use at a frequency not less than weekly\n\n* Acute illness likely to affect the result of study\n* Impaired ability to provide full consent to take part in the study\n* An occupation requiring strenuous physical exercise that may require a high energy diet'}, 'identificationModule': {'nctId': 'NCT03553927', 'briefTitle': 'Investigating the Physiological Effects of Weight Loss on Male Fertility', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Investigating the Physiological Effects of Weight Loss on Male Fertility', 'orgStudyIdInfo': {'id': '18HH4412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low Energy Diet', 'description': 'Commercially available diet products', 'interventionNames': ['Dietary Supplement: Low Energy Diet']}, {'type': 'OTHER', 'label': 'NHS advice on healthy eating', 'description': 'Dietary / lifestyle advice programme', 'interventionNames': ['Other: NHS advice on healthy eating']}], 'interventions': [{'name': 'Low Energy Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Caloric restriction to achieve weight loss', 'armGroupLabels': ['Low Energy Diet']}, {'name': 'NHS advice on healthy eating', 'type': 'OTHER', 'description': 'Advice on energy requirements as per the British Dietetic Association', 'armGroupLabels': ['NHS advice on healthy eating']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W12 0HS', 'city': 'North West London', 'country': 'United Kingdom', 'facility': 'Imperial College NHS Healthcare Trust', 'geoPoint': {'lat': 51.5585, 'lon': -0.23827}}], 'overallOfficials': [{'name': 'Channa Jayasena, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}