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Could a pill before IVF boost baby chances for endometriosis patients?

NCT ID NCT04173169

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether taking Elagolix (a hormone-blocking pill) for two months before IVF could improve live birth rates in women with endometriosis. 103 women participated, and the main goal was to see if more babies were born after this pre-treatment. The study compared Elagolix to a placebo to find out if it helps overcome infertility linked to endometriosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Elagolix (Orlissa)
What this could lead to
If successful, this could offer a new pre-treatment option to improve IVF success rates for women with endometriosis-related infertility.
What could go wrong
This is a single completed trial with 103 participants, so results may not apply to all. Elagolix can cause side effects like hot flashes and bone density loss.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

103 people

The number who actually took part.

Started

Mar 2022

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Women who plan to undergo IVF for treatment of infertility. 2. Age ≥18 and \<40 years at time of egg retrieval or signing informed consent. 3. Documentation of diagnosis of endometriosis by surgical visualization of endometriosis (laparoscopy or laparotomy) or diagnosis by pathology within the last 10 years before the initial trial entry visit or documentation of ovarian endometrioma \>2 cm or two or more smaller endometriomas that total \>2 cm in diameter. If entry is based on the presence of an endometrioma, transvaginal ultrasound evaluation must document the same unambiguous endometrioma on two separate occasions in more than one menstrual cycle. Images will be printed or transmitted electronically and read centrally by investigators at Yale to assure uniform diagnostic criteria (classic ground glass appearance) are applied. 4. Body mass index (BMI) of 18-40 kg/m2 (both inclusive) at screening. 5. AMH \> 0.5ng/ml, within 12 months of a fresh IVF cycle start. For frozen embryo transfers (FET) , AMH level eligibility criteria may not be met as long as the patient has at least one good quality blastocyst stored for the FET. 6. No known uterine cavity abnormalities at time of screening. Uterine cavity assessment by sonohysterogram or hysteroscopy within 12 months of embryo transfer indicating absence of focal intracavitary pathology and hence establishing adequate cavity at the time of embryo transfer. Ultrasound or MRI features suggestive of adenomyosis will be acceptable for inclusion. Type 3 fibroids are allowed up to 4cm size. 7. Presence of at least one ovary with no clinically significant abnormalities other than endometrioma. For eligible women with evidence of a hemorrhagic ovarian cyst, a repeat US will be needed in a subsequent menstrual cycle to ensure persistent cyst for patient to be deemed eligible. 8. Negative urine or cervical swab for gonorrhea and chlamydia within 12 months of screening. 9. Willing and able to comply with trial procedures, including reporting of obstetrical outcomes after delivery. Exclusion Criteria: 1. Use of depot GnRH agonists within 6 months of study start. Use of subcutaneous antagonists or nasal agonist within 2 months of study start unless part of regular IVF or previous IUI cycle°. 2. Use of depot medroxyprogesterone acetate (MPA) (injectable) or birth control implants (e.g., Implanon® or Nexplanon®) within 6 months of study start°. 3. Continuous use of oral progestins (MPA, NETA) within 1 month of study start°. 4. Use of aromatase inhibitors, danazol or hormonal contraceptives (Including combined oral contraceptive pill, progestin-only pill, transdermal patch or contraceptive ring, or double barrier contraception) within 1 month of study start. 5. Pregnancy greater than 8 weeks in length within the last 6 months. 6. Number of previous IVF/ICSI attempts ≥3 unsuccessful (negative pregnancy test). 7. Presence of hydrosalpinx measuring \>2cm on ultrasound, untreated endometrial polyps or intrauterine adhesions. 8. Abnormal cytology on a cervical screening based on the American College of Obstetricians and Gynecologists (ACOG) guidelines and patient age. (CIN1 or HPV allowed to participate in the study, CIN2 excluded unless treated and cleared, CIN3 excluded). 9. History of malignancy within 5 years of the start of screening, except for treated basal cell carcinoma and squamous cell carcinoma of the skin. 10. Any thoughts of suicide in the last 12 months per self-report, or documented in the electronic medical record (EMR). 11. Hypersensitivity to the study drugs. 12. Planned surgical treatment of endometriosis or planned surgery in the abdominal-pelvic area within the duration of the trial. 13. Untreated abnormal prolactin or TSH 14. Any conditions that preclude pregnancy. 15. Patients with a known history of a low-trauma fracture or other risk factors for osteoporosis or bone loss. 16. Patients with cirrhosis or abnormal LFTs per self report or documented in the electronic medical record (EMR). * Exclusion criteria number 1,2, and 3 are not required to be met by individuals in the standard of care arm of the study. The study team will collect the information regarding whether the subject has used these drugs in the aforementioned time frame using the concomitant medication log and the individual will be allowed to participate in the study under the standard of care arm only.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Duke Fertility

    Morrisville, North Carolina, 27560, United States

  • Johns Hopkins, Division of Reproductive Science and Women's Health Research

    Baltimore, Maryland, 21205, United States

  • Northwestern University Department of Obstetrics and Gynecology

    Chicago, Illinois, 60611, United States

  • University of Colorado Department of Obstetrics & Gynecology

    Aurora, Colorado, 80045, United States

  • Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences

    New Haven, Connecticut, 06520, United States

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Other studies related to the condition(s) this trial covers.