Elagolix for Fertility Enhancement Clinical Trial

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborators: Stanford University; University of North Carolina, Chapel Hill
• Treatments: Contraceptive Agents; Contraceptives, Oral

Criteria

Inclusion Criteria:

• Anti-Mullerian Hormone (AMH) > 0.5 and < 5

• 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