Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-03-13 @ 3:33 AM
Study NCT ID:
NCT01833858
Status:
COMPLETED
Last Update Posted:
2015-02-03
First Post:
2013-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Chorionic Gonadotrophin in an Antagonist Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-10-21', 'releaseDate': '2015-09-21'}], 'estimatedResultsFirstSubmitDate': '2015-09-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-01', 'studyFirstSubmitDate': '2013-04-04', 'studyFirstSubmitQcDate': '2013-04-16', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum level of inhibin A', 'timeFrame': '9 months'}], 'primaryOutcomes': [{'measure': 'Number of oocytes', 'timeFrame': '9 months'}, {'measure': 'Pregnancy rate', 'timeFrame': '11months'}], 'secondaryOutcomes': [{'measure': 'Cost of antagonist treatment', 'timeFrame': '9 months'}, {'measure': 'Spiral artery Doppler indices', 'timeFrame': '9 months', 'description': 'Spiral artery Doppler indices are taken as a marker of subendometrial vascularity.The lowest resistance will be the better vascularity'}, {'measure': 'The percentage of the perifollicular vascularity using power doppler', 'timeFrame': '9 months', 'description': 'The percentage of the perifollicular vascularity (\\<25%,25-50%,%0%-75%,\\>75%) as a marker of the quality of the oocytes.The more vascularity the better quality'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'A novel gonadotropin protocol for ovarian stimulation adds low-dose hCG (50- 200 IU) as a source of LH (luteinizing hormone) in the late follicular phase .\n\nThis regimen reduces the number of small pre-ovulatory follicles which could reduce the risk of OHSS(ovarian hyper stimulation syndrome). Adequate ovarian hormonal levels , oocyte maturation, avoidance of a premature LH surge, and increased pregnancy rate are the other benefits of this regimen.\n\nHCG might also affect endometrial function, stimulate endometrial growth and maturation and enhance the endometrial angiogenesis. These effects could extend the angiogenesis. These results could lengthen the implantation Window.\n\nInhibin A is a heterodimer protein and does not begin to increase until just after the increase in oestradiol in the late follicular phase, suggesting secretion by the dominant follicle. Inhibin A secretion is regulated by LH and is associated with paracrine/autocrine action on oocyte maturation. Moreover, it is related to follicular development and size, serving as a marker of follicular maturation after IVF cycles .However, the role of hCG supplementation during COH (controlled ovarian hyperstimulation)is still a matter of debate and more studies is needed. Thus, the objective of this trial was to investigate whether LH activity in the form of low dose hCG in GnRH (Gonadotropin releasing hormone)antagonist cycles would improve the quality of oocytes, level of inhibin A and endometrial vascularity.', 'detailedDescription': '* 60 women, where 30 of them will receive low dose HCG with rFSH (group 1), while the other 30 women will receive rFSH (Recombinant Follicle stimulating Hormone) with a placebo (group 2) both using the antagonist protocol as a method of induction in ICSI.\n* Women in both groups will be treated with a GnRH antagonist protocol with cetrotide(cetrorelix)\n* In Group 1, low dose hCG (200 IU per day) with rFSH will be given daily when at least six follicles of 12 mm will be observed and E2 levels are higher than 600 ng/l, until the day of the hCG trigger administration.\n* Group 2 patients received rFSH injections with a placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.\n\nIn both groups Oocytes will be retrieved 36 h after the hCG trigger shot. All mature eggs retrieved will be fertilized with intracytoplasmic sperm injection (ICSI). Fertilization will be checked at 18 hours post insemination. Embryo quality will be assessed and embryo transfer will occur at day 3.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Indication for ICSI treatment.\n2. The presence of one or two functional ovaries.\n3. Good responders to ovarian stimulation.\n4. The presence of normal uterine cavity\n5. Basal (day 2 or 3) serum FSH (follicle stimulating Hormone) levels ≤13 IU\n6. No untreated endocrinologic disease\n\nExclusion Criteria:\n\n1. Abnormal uterine cavity.\n2. Basal (day 2 or 3) serum FSH levels ≥13 IU.\n3. Poor responders to ovarian stimulation according to the existence of at least two of the following criteria:Advanced maternal age (above 40 years), antral follicles count \\<5, prior history of poor response to controlled ovarian hyperstimulation (peak E2 \\<500 pg/ml and/or ≤3 oocytes retrieved).\n4. Untreated endocrinologic disease.\n5. Azoospermia. all patients should be managed in Cairo,Egypt'}, 'identificationModule': {'nctId': 'NCT01833858', 'acronym': 'HCG', 'briefTitle': 'Human Chorionic Gonadotrophin in an Antagonist Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Role of Low Dose HCG in Improving the Quality of Antagonist Protocol in Patient Undergoing ICSI', 'orgStudyIdInfo': {'id': 'Protocol100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo +rFSH', 'description': 'Patients received rFSH injections with a placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose HCG with rFSH', 'description': 'Low dose hCG (200 IU per day) will be given daily with rFSH when at least six follicles of 12 mm will be observed and E2 levels are higher than 600 ng/l, until the day of the hCG trigger administration', 'interventionNames': ['Drug: Low dose HCG']}], 'interventions': [{'name': 'Low dose HCG', 'type': 'DRUG', 'otherNames': ['Human chorionic gonadotrophin'], 'description': 'Low dose hCG (200 IU per day) will be given daily when at least six follicles of 12 mm will be observed and E2 (Estradiol) levels are higher than 600 ng/l, until the day of the HCG trigger administration.', 'armGroupLabels': ['Low dose HCG with rFSH']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['saline 0.9%'], 'description': 'Patients received rFSH injections with Placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.', 'armGroupLabels': ['Placebo +rFSH']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Eman Elkattan', 'investigatorAffiliation': 'Cairo University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-09-21', 'type': 'RELEASE'}, {'date': '2015-10-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Eman Elkattan, Dr., Cairo University'}}}}