Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-03 @ 12:59 AM
Study NCT ID:
NCT01984320
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cabergoline and Coasting to Prevent OHSS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020554', 'term': 'Sperm Injections, Intracytoplasmic'}], 'ancestors': [{'id': 'D005307', 'term': 'Fertilization in Vitro'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-11', 'studyFirstSubmitDate': '2013-10-31', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Metaphase II (MII) oocytes', 'timeFrame': '1 day', 'description': 'Number of MII oocytes collected on the day of oocyte collection'}, {'measure': 'Fertilization rate', 'timeFrame': '2 days', 'description': 'Number of embryos that show signs of fertilization in each patient'}, {'measure': 'Number of embryos', 'timeFrame': '3 to 5 days', 'description': 'Number of embryos assessed for embryo transfer in each patient'}, {'measure': 'Implantation rate', 'timeFrame': '5 weeks', 'description': 'the ratio of the number of gestational sacs to the number of embryos transferred'}, {'measure': 'Chemical pregnancy rate', 'timeFrame': '14 days', 'description': 'The patients who have a positive quantitative Beta human chorionic gonadotrophin (BHCG) and do not continue their pregnancy with a drop in the result and start of menstruation'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '28 days', 'description': 'patients who show an intra-uterine gestational sac with positive fetal pulsations on ultrasound 14 days after their pregnancy test'}, {'measure': 'Early miscarriage rate', 'timeFrame': '12 weeks', 'description': 'pregnancy loss in the first 12 weeks of gestation'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '12 weeks', 'description': 'pregnancies going beyond 12 weeks of gestation'}, {'measure': 'Live birth rate', 'timeFrame': '40 weeks', 'description': 'live births occuring'}], 'primaryOutcomes': [{'measure': 'Rate and degree of OHSS (composite outcome)', 'timeFrame': '14 days', 'description': 'Symptoms of nausea, vomiting, shortness of breath, abdominal pain,abdominal distension. Ovarian size and fluid in douglas pouch by ultrasound. Haematocrit, total leucocytic count, creatinine and Estradiol level as biochemical markers. Early OHSS first 9 days after ovum pickup and late is after 9 days till 14 days (time of pregnancy test)'}], 'secondaryOutcomes': [{'measure': 'Number of oocytes', 'timeFrame': '1 day', 'description': 'Number of oocytes collected on the day of oocyte collection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OHSS', 'ICSI', 'Coasting', 'Cabergoline'], 'conditions': ['OHSS']}, 'referencesModule': {'references': [{'pmid': '23677417', 'type': 'BACKGROUND', 'citation': 'Esinler I, Bozdag G, Karakocsokmensuer L. Preventing ovarian hyperstimulation syndrome: cabergoline versus coasting. Arch Gynecol Obstet. 2013 Nov;288(5):1159-63. doi: 10.1007/s00404-013-2875-z. Epub 2013 May 16.'}, {'pmid': '29055130', 'type': 'DERIVED', 'citation': 'Bassiouny YA, Dakhly DMR, Bayoumi YA, Salaheldin NM, Gouda HM, Hassan AA. Randomized trial of combined cabergoline and coasting in preventing ovarian hyperstimulation syndrome during in vitro fertilization/intracytoplasmic sperm injection cycles. Int J Gynaecol Obstet. 2018 Feb;140(2):217-222. doi: 10.1002/ijgo.12360. Epub 2017 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.', 'detailedDescription': 'To randomly compare three study groups under a high risk of developing OHSS to one of three arms of management, either coasting for 1 to 3 days or receiving cabergoline for 8 days or coasting for 1 day plus receiving cabergoline for 8 days in ICSI patients following the long luteal GnRH agonist protocol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\<or= 35, BMI \\<or= 30\n2. Long protocol GnRH agonist cycles\n3. Estradiol level on day of HCG \\>or= 3500 pg/ml\n4. Retrieving more than 15 oocytes\n\nExclusion Criteria:\n\n1. Male factor\n2. Uterine factor'}, 'identificationModule': {'nctId': 'NCT01984320', 'acronym': 'OHSS', 'briefTitle': 'Cabergoline and Coasting to Prevent OHSS', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Combining Cabergoline and Coasting in Gonadotropin Releasing Hormone(GnRH)Agonist Protocol in Intracytoplasmic Sperm Injection (ICSI) to Prevent Ovarian Hyperstimulation Syndrome (OHSS): a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '92013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Coasting', 'description': 'In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 to 3 days until drop of estradiol to a safe level to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.', 'interventionNames': ['Procedure: ICSI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cabergoline', 'description': 'In their ICSI cycle patients will take 0.25 mg of cabergoline daily for 8 days from HCG triggering day to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.', 'interventionNames': ['Procedure: ICSI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Coasting and Cabergoline', 'description': 'In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 day plus receiving 0.25 mg of cabergoline daily for 8 days from HCG triggering day to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.', 'interventionNames': ['Procedure: ICSI']}], 'interventions': [{'name': 'ICSI', 'type': 'PROCEDURE', 'description': 'Long luteal GnRH agonist protocol: patients will receive GnRH agonist from day 21 of the previous cycle of stimulation and then on day 3 of the stimulation cycle they will start hMG injections with 225 IU/day. Folliculometry will start on day 6 stimulation by vaginal ultrasound. Estradiol levels will be measured on day 8, 10 and 12 of stimulation if appropriate. According to ultrasound and estradiol level patients will be randomized to either one of the study arms. When ready final triggering will be done by human chorionic gonadotropin (10000 IU) and oocyte collection is done at 36 hour from triggering. Embryo transfer is then done 3 days afterwards with ultrasound guidance.', 'armGroupLabels': ['Cabergoline', 'Coasting', 'Coasting and Cabergoline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed Roushdy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yasmin Ahmed Bassiouny', 'investigatorAffiliation': 'Cairo University'}}}}