Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-31 @ 3:14 PM
Study NCT ID:
NCT04414761
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2020-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D004394', 'term': 'Dydrogesterone'}, {'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}, {'id': 'C062876', 'term': 'cetrorelix'}, {'id': 'C061018', 'term': 'ganirelix'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011245', 'term': 'Pregnadienes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 784}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-06-02', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'live birth rate', 'timeFrame': 'deliveries ≥22 weeks gestation with heartbeat and breath', 'description': 'live birth rate of the first frozen embryo transfer cycle'}], 'secondaryOutcomes': [{'measure': 'positive serum hCG', 'timeFrame': '2 weeks after FET', 'description': 'serum β-hCG ≥10 mIU/mL of the first FET'}, {'measure': 'clinical pregnancy', 'timeFrame': "6 weeks' gestation", 'description': 'presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET'}, {'measure': 'biochemical pregnancy', 'timeFrame': "6 weeks' gestation", 'description': 'positive serum hCG not followed by clinical pregnancy of the first FET'}, {'measure': 'implantation rate', 'timeFrame': "6 weeks' gestation", 'description': 'the number of gestational sacs per blastocyst transferred of the first FET'}, {'measure': 'ongoing pregnancy', 'timeFrame': "12 weeks' gestation", 'description': "a viable pregnancy beyond 12 weeks' gestation of the first FET"}, {'measure': 'cumulative live birth', 'timeFrame': "2 years' after FET", 'description': 'cumulative live birth within 6 months of randomization'}, {'measure': 'number of oocytes retrieved', 'timeFrame': '1 day after oocyte retrieval', 'description': 'number of oocytes retrieved'}, {'measure': 'number and grading of blastocysts', 'timeFrame': '1 week after oocyte retrieval', 'description': 'number and grading of blastocysts suitable for biopsy and freezing'}, {'measure': 'multiple pregnancy', 'timeFrame': 'multiple pregnancy beyond gestation 12 weeks', 'description': 'more than one intrauterine sacs on scanning'}, {'measure': 'ectopic pregnancy', 'timeFrame': 'ectopic pregnancy during 12 weeks gestation', 'description': 'pregnancy outside the uterine cavity'}, {'measure': 'birthweight of newborns', 'timeFrame': '1 year after FET', 'description': 'the birth weight of newborns'}, {'measure': 'serum baseline FSH', 'timeFrame': 'day 2-3 of period', 'description': 'baseline FSH of period day 2-3'}, {'measure': 'estradiol level on the trigger day', 'timeFrame': '2 days before oocyte retrieval'}, {'measure': 'progesterone level on the trigger day', 'timeFrame': '2 days before oocyte retrieval'}, {'measure': 'estradiol and progesterone levels in the follicular fluid', 'timeFrame': '1 year after FET', 'description': 'estradiol and progesterone levels in the follicular fluid'}, {'measure': 'miscarriage', 'timeFrame': '22 weeks of pregnancy', 'description': 'clinically recognised pregnancy loss before 22 weeks of pregnancy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IVF', 'GnRH Antagonist', 'PPOS']}, 'referencesModule': {'references': [{'pmid': '30927417', 'type': 'BACKGROUND', 'citation': 'Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.'}, {'pmid': '29300975', 'type': 'BACKGROUND', 'citation': 'Yu S, Long H, Chang HY, Liu Y, Gao H, Zhu J, Quan X, Lyu Q, Kuang Y, Ai A. New application of dydrogesterone as a part of a progestin-primed ovarian stimulation protocol for IVF: a randomized controlled trial including 516 first IVF/ICSI cycles. Hum Reprod. 2018 Feb 1;33(2):229-237. doi: 10.1093/humrep/dex367.'}, {'pmid': '28062551', 'type': 'BACKGROUND', 'citation': 'Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047.'}, {'pmid': '25956370', 'type': 'BACKGROUND', 'citation': 'Kuang Y, Chen Q, Fu Y, Wang Y, Hong Q, Lyu Q, Ai A, Shoham Z. Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril. 2015 Jul;104(1):62-70.e3. doi: 10.1016/j.fertnstert.2015.03.022. Epub 2015 May 5.'}, {'pmid': '28276192', 'type': 'BACKGROUND', 'citation': 'Dong J, Wang Y, Chai WR, Hong QQ, Wang NL, Sun LH, Long H, Wang L, Tian H, Lyu QF, Lu XF, Chen QJ, Kuang YP. The pregnancy outcome of progestin-primed ovarian stimulation using 4 versus 10 mg of medroxyprogesterone acetate per day in infertile women undergoing in vitro fertilisation: a randomised controlled trial. BJOG. 2017 Jun;124(7):1048-1055. doi: 10.1111/1471-0528.14622.'}, {'pmid': '32327297', 'type': 'BACKGROUND', 'citation': 'Alexandru P, Cekic SG, Yildiz S, Turkgeldi E, Ata B. Progestins versus GnRH analogues for pituitary suppression during ovarian stimulation for assisted reproductive technology: a systematic review and meta-analysis. Reprod Biomed Online. 2020 Jun;40(6):894-903. doi: 10.1016/j.rbmo.2020.01.027. Epub 2020 Feb 5.'}, {'pmid': '38272383', 'type': 'DERIVED', 'citation': 'Chen ZQ, Ai A, Zhang Y, Li H, Wang JY, Wang L, Ng EHY. A randomized controlled trial to compare the live birth rate of the first frozen embryo transfer following the progestin-primed ovarian stimulation protocol vs. the antagonist protocol in women with an anticipated high ovarian response. Fertil Steril. 2024 Jun;121(6):937-945. doi: 10.1016/j.fertnstert.2024.01.027. Epub 2024 Jan 23.'}]}, 'descriptionModule': {'briefSummary': 'Progestin can inhibit the pituitary LH surge during ovarian stimulation and various studies show progestin-primed ovarian stimulation (PPOS) is effective in blocking the LH surge in IVF. More and more centers in China are using PPOS because this regimen appears simpler and cheaper.A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF in terms of the live birth rate is urgently needed.\n\nTrial objectives: To compare the live birth rate between the PPOS protocol and the antagonist protocol used for ovarian stimulation during IVF\n\nEligible women will be randomised into one of the two groups:\n\nAntagonist group : Women will receive antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.\n\nPPOS group: Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.\n\nThere will be no fresh transfer. Only one blastocyst will be allowed to replaced in the first FET and a maximum of two blastocysts will be replaced in the subsequent FET cycles.\n\nThe primary outcome is the live birth rate of the first frozen-thawed transfer cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of women \\<43 years at the time of ovarian stimulation for IVF\n* The first IVF cycle\n* Antral follicle count (AFC) \\>15 on day 2-5 of the period\n\nExclusion Criteria:\n\n* Presence of a functional ovarian cyst with E2\\>100 pg/mL\n* Recipient of oocyte donation\n* Undergoing preimplantation genetic testing\n* Presence of hydrosalpinx or endometrial polyp which is not surgically treated'}, 'identificationModule': {'nctId': 'NCT04414761', 'briefTitle': 'Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response', 'organization': {'class': 'OTHER', 'fullName': 'ShangHai Ji Ai Genetics & IVF Institute'}, 'officialTitle': 'A Randomized Control Trial to Compare the Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response Undergoing IVF', 'orgStudyIdInfo': {'id': 'JIAI 2020-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Antagonist group', 'description': 'Women will receive antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.', 'interventionNames': ['Drug: GnRH Antagonist']}, {'type': 'EXPERIMENTAL', 'label': 'PPOS group', 'description': 'Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.', 'interventionNames': ['Drug: Progesterone']}], 'interventions': [{'name': 'Progesterone', 'type': 'DRUG', 'otherNames': ['medroxyprogesterone', 'duphaston'], 'description': 'oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger', 'armGroupLabels': ['PPOS group']}, {'name': 'GnRH Antagonist', 'type': 'DRUG', 'otherNames': ['Cetrorelix', 'Ganirelix'], 'description': 'GnRH antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger', 'armGroupLabels': ['Antagonist group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'ShangHai JIAI Genetics&IVF Institute', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'XIAOXI SUN, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai JiAi Genetics & IVF Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available when beginning 3 months and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared.', 'accessCriteria': 'To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with. Proposals should be sent to lihe198900@163.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ShangHai Ji Ai Genetics & IVF Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}