Elagolix for Fertility Enhancement Clinical Trial (EFFECT)

IRB00059474

Studies suggest that undiagnosed endometriosis results in poor reproductive outcomes in the setting of In Vitro Fertilization and Embryo Transfer (IVF-ET). Biomarkers that predict endometriosis including B-cell lymphoma (BCL6) and Sirtuin 1 (SIRT1) are associated with reduced pregnancy rates following IVF-ET. Treatment with gonadotropin releasing hormone (GnRHr) receptor agonists (leuprolide acetate depot) has been shown to improve pregnancy rates following embryo transfer (ET). In this randomized controlled trial, a new generation GnRHr antagonist, elagolix, will be compared to oral contraceptives (OCPs) for suppression of suspected endometriosis prior to ET. Both groups will receive two months of treatment prior to frozen embryo transfer of a single euploid embryo. Outcomes will include pregnancy rate, miscarriage rate and ongoing and live birth rate following treatment. Patients experiencing unanticipated problems or who experience adverse events such that they do not tolerate the treatment they are assigned, will be allowed to discontinue treatment and be provided the opportunity to use the other treatment if they so choose. The outcomes of such cycles would be collected separately and included as observational data only and not included in the randomized data analysis. Alternatively, they can simply drop out of the study and resume medical therapy as appropriate or pursue frozen embryo transfer as previously planned.

2022-01-15

2023-08-09

2023-08-09

Completed

Early phase I

10

Inclusion Criteria: * Anti-Mullerian Hormone (AMH) \> 0.5 and \< 10 * At least 1 euploid embryo for transfer * Prior endometrial biopsy showing elevated BCL6 and SIRT1 expression * Endometrial thickness \> 5.9 and \< 14 mm Exclusion Criteria: * Uterine fibroids \> 4 cm (intramural) * Polycystic ovary syndrome (Rotterdam criteria) * Ovarian failure and donor eggs or oocytes * Positive lupus anticoagulant or positive anti-cardiolipin antibody testing * Diabetes mellitus (Type I or II) * Untreated hypothyroidism * Untreated hyperprolactinemia * BMI \<17 or \> 35 * Uncorrected uterine anomaly

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2024-06-11