Elagolix for Fertility Enhancement Clinical Trial

(EFFECT Trial)

Overseen By Dan Angress

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is comparing a new medication called elagolix to birth control pills in women who have had unsuccessful IVF treatments and may have undiagnosed endometriosis. Elagolix helps by blocking hormones that can make endometriosis worse, which might improve pregnancy rates.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves specific treatments for endometriosis, it's best to discuss your current medications with the trial coordinators or your doctor.

Research Team

Bruce A Lessey, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

Inclusion Criteria

At least 1 euploid embryo for transfer

Endometrial thickness > 5.9 and < 14 mm

Anti-Mullerian Hormone (AMH) > 0.5 and < 10

Exclusion Criteria

You have not received treatment for an underactive thyroid.

Uterine fibroids > 4 cm (intramural)

Positive lupus anticoagulant or positive anti-cardiolipin antibody testing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either elagolix or oral contraceptives for suppression of suspected endometriosis prior to embryo transfer

8 weeks

Regular visits for monitoring and medication administration

Frozen Embryo Transfer (FET)

Participants undergo frozen embryo transfer of a single euploid embryo

1 week

1 visit for embryo transfer procedure

Follow-up

Participants are monitored for pregnancy outcomes, including miscarriage and live birth rates

15 weeks

Follow-up visits to assess pregnancy outcomes

Treatment Details

Interventions

• Elagolix
• Oral Contraceptive

Participant Groups

Group I: Elagolix Experimental Treatment 1 Intervention

Elagolix will be dosed at the higher dose used in pelvic pain trials, 200 mg twice a day for 2 months.

Group II: Oral contraceptives (Ortho Cyclen) Active Control 1 Intervention

Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills.

Elagolix is already approved in United States for the following indications:

Approved in United States as Orilissa for:

• Management of moderate to severe pain associated with endometriosis

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+