Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-22 @ 7:26 AM
Study NCT ID:
NCT02772120
Status:
WITHDRAWN
Last Update Posted:
2019-09-09
First Post:
2016-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Vaginal and Intramuscular Progesterone in Vitrified-warmed Blastocyst Transfer Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C400424', 'term': 'Crinone'}, {'id': 'D011374', 'term': 'Progesterone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Before enrollment, suspended due to changing insurance coverage of study drugs.', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'lastUpdateSubmitDate': '2019-09-06', 'studyFirstSubmitDate': '2016-05-11', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '5-6 weeks', 'description': 'Percentage of patients with intrauterine gestational sac by ultrasound'}], 'secondaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': '5-6 weeks', 'description': 'Maximum number of gestational sacs divided by total number of embryos transferred'}, {'measure': 'Sustained implantation rate', 'timeFrame': '7 weeks', 'description': 'maximum number of fetal heartbeats divided by total number of embryos transferred'}, {'measure': 'Biochemical pregnancy', 'timeFrame': '6 weeks', 'description': 'Positive serum b-hCG (above 5 IU/L) without subsequent ultrasound evidence of pregnancy'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '7-8 weeks', 'description': 'Live intrauterine pregnancy at the time of transfer to obstetrical care'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Infertility', 'In vitro fertilization', 'Embryo transfer', 'Blastocyst', 'Progesterone', 'Crinone'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '26222435', 'type': 'BACKGROUND', 'citation': 'Wang Y, He Y, Zhao X, Ji X, Hong Y, Wang Y, Zhu Q, Xu B, Sun Y. Crinone Gel for Luteal Phase Support in Frozen-Thawed Embryo Transfer Cycles: A Prospective Randomized Clinical Trial in the Chinese Population. PLoS One. 2015 Jul 29;10(7):e0133027. doi: 10.1371/journal.pone.0133027. eCollection 2015.'}, {'pmid': '10527993', 'type': 'BACKGROUND', 'citation': 'Lightman A, Kol S, Itskovitz-Eldor J. A prospective randomized study comparing intramuscular with intravaginal natural progesterone in programmed thaw cycles. Hum Reprod. 1999 Oct;14(10):2596-9. doi: 10.1093/humrep/14.10.2596.'}, {'pmid': '24847018', 'type': 'BACKGROUND', 'citation': 'Shapiro DB, Pappadakis JA, Ellsworth NM, Hait HI, Nagy ZP. Progesterone replacement with vaginal gel versus i.m. injection: cycle and pregnancy outcomes in IVF patients receiving vitrified blastocysts. Hum Reprod. 2014 Aug;29(8):1706-11. doi: 10.1093/humrep/deu121. Epub 2014 May 20.'}, {'pmid': '22310935', 'type': 'BACKGROUND', 'citation': 'Berger BM, Phillips JA. Pregnancy outcomes in oocyte donation recipients: vaginal gel versus intramuscular injection progesterone replacement. J Assist Reprod Genet. 2012 Mar;29(3):237-42. doi: 10.1007/s10815-011-9691-9. Epub 2012 Feb 4.'}], 'seeAlsoLinks': [{'url': 'http://druginfo.nlm.nih.gov/drugportal/name/Progesterone', 'label': 'Drug information for progesterone'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test the hypothesis that the pregnancy rates of women (ages 18-50 years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41 years of age) as part of their IVF treatment are not different with respect to the administration of progesterone (Crinone® 8% vaginal gel versus intramuscular progesterone).', 'detailedDescription': 'The hypothesis of this study is that the type of progesterone administered (intramuscular progesterone or Crinone® 8% vaginal gel) does not affect implantation and clinical pregnancy rates in women receiving cryo-thawed blastocysts that were produced using their own eggs and frozen before age 41 years. Both intramuscular progesterone (25-100 mg compounded in oil) or vaginal progesterone (Crinone® 8% vaginal progesterone gel) are widely used for luteal phase support in patients receiving vitrified-warmed embryos. Crinone® 8% is FDA approved for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency (FDA approval letter, 1997).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent\n* Patient age at time of embryo freezing: 18 to 40.9 years\n* Patient age at embryo transfer: 18 to 50 years (i.e. women currently ages 18-50 years who are transferring embryos created using eggs retrieved from women aged 18-40.9 years)\n* Blastocysts frozen by vitrification at Brigham and Women's Hospital\n* Standard eligibility criteria for blastocyst transfer at Brigham and Women's Hospital\n\nExclusion Criteria:\n\n* Fresh or cleavage-stage embryo transfer planned\n* Gestational carrier cycles\n* Natural and modified natural cycles\n* Embryos frozen more than once or derived from thawed oocytes\n* Embryos frozen at centers other than Brigham and Women's Hospital\n* Embryos frozen using techniques other than vitrification (i.e. slow frozen)\n* Patients with recurrent pregnancy loss, defined as failure of 3 or more clinical pregnancies\n* Uterine factor infertility: Asherman's, submucosal fibroids, polyp greater than 1 cm at time of embryo transfer, uninterrupted hydrosalpinx\n* Patients with three prior failed embryo transfers (fresh or frozen)\n* BMI\\<18 or \\>40 kg/m2 at screening\n* Currently breast feeding or pregnant\n* Embryo biopsy performed\n* Current smoking, alcohol or illicit drug use\n* Allergy to study drugs\n* Refusal or inability to adhere to study protocol\n* Participation in other experimental drug trials concurrently within the past 60 days"}, 'identificationModule': {'nctId': 'NCT02772120', 'briefTitle': 'Comparison of Vaginal and Intramuscular Progesterone in Vitrified-warmed Blastocyst Transfer Cycles', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Comparison of Vaginal Progesterone Gel (Crinone 8%®) and Intramuscular Progesterone in Vitrified-Warmed Blastocyst Transfer Cycles', 'orgStudyIdInfo': {'id': 'BWH2016progRCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vaginal progesterone gel (Crinone® 8%)', 'description': 'Crinone® 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) is administered once 5 days prior to embryo transfer, then twice per day until the pregnancy test is negative or until the 10th week of pregnancy.', 'interventionNames': ['Drug: Vaginal progesterone gel (Crinone® 8%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intramuscular Progesterone', 'description': 'Progesterone-25 mg intramuscularly once 5 days prior to embryo transfer, then 50 mg once per day until the pregnancy test is negative or until the 10th week of pregnancy.', 'interventionNames': ['Drug: Intramuscular Progesterone']}], 'interventions': [{'name': 'Vaginal progesterone gel (Crinone® 8%)', 'type': 'DRUG', 'otherNames': ['vaginal progesterone', 'Crinone'], 'description': 'Crinone® 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) is administered once 5 days prior to embryo transfer, then twice per day until the pregnancy test is negative or until the 10th week of pregnancy.', 'armGroupLabels': ['Vaginal progesterone gel (Crinone® 8%)']}, {'name': 'Intramuscular Progesterone', 'type': 'DRUG', 'otherNames': ['progesterone'], 'description': 'Progesterone-25 mg intramuscularly once 5 days prior to embryo transfer, then 50 mg once per day until the pregnancy test is negative or until the 10th week of pregnancy.', 'armGroupLabels': ['Intramuscular Progesterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Elena Yanushpolsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Assistant Professor, Harvard Medical School, Director of Reproductive Surgery at Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Harvard Medical School', 'investigatorFullName': 'Elena Hesina Yanushpolsky, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}