Could a Pre-IVF pill boost baby chances for endometriosis patients?
NCT ID NCT06375811
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests whether taking Elagolix, a hormone-blocking drug, before IVF can increase live birth rates in women with endometriosis. About 97 women will receive either Elagolix or a placebo before their IVF cycle. The goal is to see if this pre-treatment improves the chance of having a baby.
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.
- What could go wrong
- This is a Phase 3 trial, but results are not yet available. The benefit may be modest or not apply to all women with endometriosis.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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97 people
The number who actually took part.
- Started
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Mar 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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Duke Fertility
Morrisville, North Carolina, 27560, United States
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Johns Hopkins, Division of Reproductive Science and Women's Health Research
Baltimore, Maryland, 21205, United States
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Northwestern University Department of Obstetrics and Gynecology
Chicago, Illinois, 60611, United States
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University of Colorado Department of Obstetrics & Gynecology
Aurora, Colorado, 80045, United States
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Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences
New Haven, Connecticut, 06520, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Pre-Surgery pelvic floor therapy stop endometriosis pain after the operation?
- The hidden handshake that decides whether an embryo implants
- Appendix: the hidden driver of endometriosis pain?
- Allergy pill put to the test against endometriosis pain
- Do infertility treatments leave a metabolic mark on children?
- Could a Woman's biological clock also predict her Heart's future?