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NCT04039204 · ClinicalTrials.gov registry record · Phase 2
Elagolix for Fertility Enhancement Clinical Trial
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT04039204 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 10 participants.
The verdict
NCT04039204, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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. 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.
Interventions
- DRUG Elagolix
- DRUG Ortho Cyclen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-01-15 |
| Est. Completion | 2023-08-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04039204
The ClinicalTrials.gov registry entry for NCT04039204 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Elagolix is the first listed.
NCT04039204 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04039204 about?
NCT04039204 is a clinical study titled "Elagolix for Fertility Enhancement Clinical Trial". 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 followi...
What is the current status of trial NCT04039204?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2022-01-15. Estimated completion is 2023-08-09.
What interventions are being tested in trial NCT04039204?
The interventions under investigation include: Elagolix (DRUG), Ortho Cyclen (DRUG).
Who is sponsoring clinical trial NCT04039204?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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