Elagolix for Fertility Enhancement Clinical Trial

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04039204
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 42 Years
Healthy Volunteers
Not accepted

Interventions

  • Elagolix — DRUG
    This orally active, reversible GnRH antagonist will be used to suppress endometriosis by lowering estrogen levels for 2 months prior to FET
  • Ortho Cyclen — DRUG
    Oral contraceptive prescribed by physician.

Study Details

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.

Key Dates

Start date
Jan 15, 2022
Status verified
Dec 2023
Primary completion
Aug 9, 2023
Completion
Aug 9, 2023

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elagolix
    Elagolix will be dosed at the higher dose used in pelvic pain trials, 200 mg twice a day for 2 months.
  • Active Comparator: Oral contraceptives (Ortho Cyclen)
    Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills.

Primary Outcome Measure

Number of Live Births [ Time Frame: Month 9 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Univesity Health SciencesWinston-SalemNorth Carolina27157-

Find similar trials in Winston-Salem, NC

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Wake Forest Univesity Health Sciences· Winston-Salem, NC

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