Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 4:40 AM
Study NCT ID:
NCT04002635
Status:
WITHDRAWN
Last Update Posted:
2021-01-08
First Post:
2019-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Practical issues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-06', 'studyFirstSubmitDate': '2019-06-27', 'studyFirstSubmitQcDate': '2019-06-27', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'early pregnancy loss', 'timeFrame': '12 weeks after frozen embryo transfer'}], 'secondaryOutcomes': [{'measure': 'cancellation rate', 'timeFrame': '2 months'}, {'measure': 'number of visits to the clinic', 'timeFrame': '2 months'}, {'measure': 'endometrial thickness on the day of planning of FET', 'timeFrame': '1 day'}, {'measure': 'implantation rate', 'timeFrame': '1 day'}, {'measure': 'biochemical and clinical pregnancy rate', 'timeFrame': '12 weeks'}, {'measure': 'live birth rate', 'timeFrame': '1 year'}, {'measure': 'neonatal birth weight', 'timeFrame': '1 year'}, {'measure': 'term of delivery', 'timeFrame': '1 year'}, {'measure': 'hypertensive disorders of pregnancy', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['frozen embryo transfer'], 'conditions': ['Infertility, Female', 'Polycystic Ovary Syndrome', 'IVF', 'Ovulation Disorder']}, 'descriptionModule': {'briefSummary': 'To offer patients with oligomenorrhoea or amenorrhoea an alternative to frozen embryo transfer in an artificial cycle, endometrial preparation using letrozole may be a valuable option. Letrozole, a potent, reversible nonsteroidal aromatase inhibitor with relatively short half-life, can successfully induce ovulation without any adverse anti-estrogenic effects and thus without affecting the endometrium. The use of letrozole typically results in monofollicular growth and this reduces the effect of supraphysiological levels of estrogen on the endometrium and embryo. The purpose of this study is to compare a frozen-thawed embryo transfer in an artificial cycle with a letrozole-induced ovulatory cycle, specifically in PCOS patients. The primary outcome is early pregnancy loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than or equal to 18 and less than or equal to 40\n* BMI more than or equal to 18 and less than or equal to 35\n* Diagnosis of PCOS according to Rotterdam criteria\n* Normal gynaecological ultrasound \\< 6 months before inclusion\n* Signed informed consent form\n* Day 5 or 6 frozen-thawed embryo transfer, blastocyst stage\n\nExclusion Criteria:\n\n* Recurrent implantation failure\n* Recurrent miscarriage\n* Presence of adenomyosis\n* Untreated intrauterine pathology\n* rAFS (revised American Fertility Society) Grade III or IV endometriosis\n* Hydrosalpinx\n* In vitro maturation (IVM)\n* Untreated autoimmune disorders\n* (History of) malignancy\n* Allergy or reaction to the use of progynova, utrogestan and/or letrozole in the past\n* Pre-implantation genetic testing (PGT)'}, 'identificationModule': {'nctId': 'NCT04002635', 'acronym': 'LEFT', 'briefTitle': 'Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'CRG UZ Brussel'}, 'officialTitle': 'Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients', 'orgStudyIdInfo': {'id': '2019LEFT001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hormonal Replacement Therapy', 'description': 'Artificial preparation of the endometrium using estradiol valerate 2mg 3x/day, and vaginal micronized progesterone 2x 400mg/day.', 'interventionNames': ['Drug: estradiol valerate']}, {'type': 'EXPERIMENTAL', 'label': 'Letrozole', 'description': 'Using letrozole for ovulation induction before planning the frozen embryo transfer', 'interventionNames': ['Drug: Letrozole']}], 'interventions': [{'name': 'Letrozole', 'type': 'DRUG', 'description': 'Letrozole ovulation induction', 'armGroupLabels': ['Letrozole']}, {'name': 'estradiol valerate', 'type': 'DRUG', 'otherNames': ['progesterone'], 'description': 'hormonal replacement therapy', 'armGroupLabels': ['Hormonal Replacement Therapy']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'Sharing with other study site, UZ Gent'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CRG UZ Brussel', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Liese Boudry', 'investigatorAffiliation': 'CRG UZ Brussel'}}}}