Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
Study NCT ID:
NCT04008966
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2019-07-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}, {'id': 'C062876', 'term': 'cetrorelix'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D004624', 'term': 'Embryo Transfer'}], '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': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of mature follicular count', 'timeFrame': '10 - 14 days of the cycle', 'description': 'number of follicles larger than 14 mm'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Assisted Reproduction']}, 'referencesModule': {'references': [{'pmid': '33011968', 'type': 'DERIVED', 'citation': 'Maged AM, Ragab MA, Shohayeb A, Saber W, Ekladious S, Hussein EA, El-Mazny A, Hany A. Comparative study between single versus dual trigger for poor responders in GnRH-antagonist ICSI cycles: A randomized controlled study. Int J Gynaecol Obstet. 2021 Mar;152(3):395-400. doi: 10.1002/ijgo.13405. Epub 2020 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'All participants started with a combination of recombinant FSH 300 U and urinary Gn 150 U from the 2nd day of the cycle then the dose was adjusted according to the ovarian response\n\nFrom day 6 of the cycle, follow up using transvaginal ultrasound was done either daily or on alternate days according to the ovarian response. When the leading follicle reached 12 mm, GnRH antagonist was started using Cetrotide 0.25 subcutaneously daily till the day of triggering. Triggering was done when at least 3 follicles larger than 14 mm and at least one of them reached a mean diameter of 17 mm or more.\n\nAt the day of triggering, women were randomized into 2 groups. Group I (single trigger group) that included 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection. Group II (Dual trigger group) that included 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection in addition to GnRH agonist triptorelin 0.2 mg subcutaneously.\n\nOvum pickup was done 34 hours after triggering under the guidance of transvaginal ultrasound.\n\nISM1 culture medium was used for oocyte collection and embryo culture. Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter by the same expert operator\n\nCycle cancellation was done if day 9 folliculometry revealed less than 2 mature follicles, no oocytes were retrieved or if fertilization failed\n\nLuteal phase support was started in all women on the day of oocyte retrieval and continued till the day of serum β-hCG assessment (done 14 days after ET) through administration of 400 mg of natural Progesterone twice daily per vagina . In women with +ve serum β-hCG (\\> 5 mIU/ml), transvaginal ultrasound evaluation was done 4 weeks after ET to confirm the presence and number of intrauterine gestational sacs.', 'detailedDescription': 'All participants started with a combination of recombinant FSH 300 U and urinary Gn 150 U from the 2nd day of the cycle then the dose was adjusted according to the ovarian response evaluated by transvaginal ultrasound and serum E2. Delayed start\n\nFrom day 6 of the cycle, follow up using transvaginal ultrasound was done either daily or on alternate days according to the ovarian response. Ultrasound follow up reported number and size of follicles in each ovary and the endometrial thickness and pattern. When the leading follicle reached 12 mm, GnRH antagonist was started using Cetrotide 0.25 subcutaneously daily till the day of triggering. Triggering was done when at least 3 follicles larger than 14 mm and at least one of them reached a mean diameter of 17 mm or more.\n\nAt the day of triggering, women were randomized into 2 groups. Group I (single trigger group) that included 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection. Group II (Dual trigger group) that included 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection in addition to GnRH agonist triptorelin 0.2 mg subcutaneously.\n\nOvum pickup was done 34 hours after triggering under the guidance of transvaginal ultrasound.\n\nISM1 culture medium was used for oocyte collection and embryo culture. Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter by the same expert operator\n\nCycle cancellation was done if day 9 folliculometry revealed less than 2 mature follicles, no oocytes were retrieved or if fertilization failed\n\nLuteal phase support was started in all women on the day of oocyte retrieval and continued till the day of serum β-hCG assessment (done 14 days after ET) through administration of 400 mg of natural Progesterone twice daily per vagina . In women with +ve serum β-hCG (\\> 5 mIU/ml), transvaginal ultrasound evaluation was done 4 weeks after ET to confirm the presence and number of intrauterine gestational sacs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '25 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with poor ovarian response candidate for ICSI\n* women with spontaneous normal menstrual cycle\n* normal uterine cavity\n\nExclusion Criteria:\n\n* women with ovarian cysts\n* endometriosis\n* hydrosalpinx\n* endocrinological disorders as hyperprolactinemia, thyroid or adrenal disorders.\n* Couples with azospermic male partner\n* those with severe uncontrolled medical or metabolic disorders'}, 'identificationModule': {'nctId': 'NCT04008966', 'briefTitle': 'Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles. A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '58'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'single trigger', 'description': '80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection', 'interventionNames': ['Drug: combined oral contaraceptive pills', 'Drug: recombinant FSH', 'Drug: Urinaru gonadotropin', 'Drug: GnRH antagonist', 'Drug: Human chorionic gonadotropin', 'Procedure: Ovum pick up', 'Procedure: Embryo transfer', 'Drug: natural Progesterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dual trigger', 'description': '80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection in addition to GnRH agonist triptorelin 0.2 mg subcutaneously', 'interventionNames': ['Drug: combined oral contaraceptive pills', 'Drug: recombinant FSH', 'Drug: Urinaru gonadotropin', 'Drug: GnRH antagonist', 'Drug: Human chorionic gonadotropin', 'Drug: GnRH agonist', 'Procedure: Ovum pick up', 'Procedure: Embryo transfer', 'Drug: natural Progesterone']}], 'interventions': [{'name': 'combined oral contaraceptive pills', 'type': 'DRUG', 'otherNames': ['Gynera'], 'description': '1 tablet daily between days 5 and 25 of the cycle before stimulation', 'armGroupLabels': ['Dual trigger', 'single trigger']}, {'name': 'recombinant FSH', 'type': 'DRUG', 'description': '300 U from the 2nd day of the cycle then the dose was adjusted according to the ovarian response evaluated by transvaginal ultrasound and serum E2', 'armGroupLabels': ['Dual trigger', 'single trigger']}, {'name': 'Urinaru gonadotropin', 'type': 'DRUG', 'description': '150 U from the 2nd day of the cycle then the dose was adjusted according to the ovarian response evaluated by transvaginal ultrasound and serum E2', 'armGroupLabels': ['Dual trigger', 'single trigger']}, {'name': 'GnRH antagonist', 'type': 'DRUG', 'otherNames': ['Cetrotide'], 'description': '0.25 subcutaneously daily from the day in which the leading follicles reached 12 mm till the day of triggering', 'armGroupLabels': ['Dual trigger', 'single trigger']}, {'name': 'Human chorionic gonadotropin', 'type': 'DRUG', 'description': '10,000 IU intramuscular when at least 3 follicles larger than 14 mm and at least one of them reached a mean diameter of 17 mm or more', 'armGroupLabels': ['Dual trigger', 'single trigger']}, {'name': 'GnRH agonist', 'type': 'DRUG', 'otherNames': ['triptorelin'], 'description': '0.2 mg subcutaneously when at least 3 follicles larger than 14 mm and at least one of them reached a mean diameter of 17 mm or more', 'armGroupLabels': ['Dual trigger']}, {'name': 'Ovum pick up', 'type': 'PROCEDURE', 'description': '34 hours after triggering under the guidance of transvaginal ultrasound', 'armGroupLabels': ['Dual trigger', 'single trigger']}, {'name': 'Embryo transfer', 'type': 'PROCEDURE', 'description': 'Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter', 'armGroupLabels': ['Dual trigger', 'single trigger']}, {'name': 'natural Progesterone', 'type': 'DRUG', 'otherNames': ['Prontogest'], 'description': '400 mg twice daily per vagina', 'armGroupLabels': ['Dual trigger', 'single trigger']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ahmed M Maged, MD', 'investigatorAffiliation': 'Cairo University'}}}}