Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis (PREGnant)
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ClinicalTrials.gov Identifier: NCT04173169 |
Recruitment Status :
Recruiting
First Posted : November 21, 2019
Last Update Posted : March 17, 2022
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Condition or disease | Intervention/treatment | Phase |
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Infertility Endometriosis | Drug: Elagolix 200 MG Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 814 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Half of the subjects (407) will receive elagolix 200mg twice a day (BID) and the other half of subjects (407) will receive placebo BID, both for a minimum of 60 days before IVF cycle start. For convenience of IVF cycle scheduling, participants may receive up to an additional 14 days of intervention (elagolix or placebo) beyond the minimum 60 days of pre-IVF treatment, such that the last dose of study intervention (elagolix or placebo)is received no more than 24 hours before start of IVF treatment protocol. |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | A computer-generated randomization list will be created by the PREGnant Data Coordinating Center (DCC) and randomization will be performed prior to the first dose of elagolix. Randomization will have random sizes (2, 4, or 6) of blocks and be stratified by site, i.e. whole blocks are assigned to sites. The randomization list will not be available to any person involved in the conduct and evaluation of the trial until the trial is complete and database is declared clean and is released by the DCC. Likewise, treatment allocation information will not be accessible to investigators (except for serious safety concerns), trial staff at the site or central laboratory personnel during the trial. |
Primary Purpose: | Treatment |
Official Title: | Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis - A Prospective Double-blind Placebo-controlled Trial |
Actual Study Start Date : | March 15, 2022 |
Estimated Primary Completion Date : | October 2023 |
Estimated Study Completion Date : | October 2024 |

Arm | Intervention/treatment |
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Experimental: Pre-IVF Treatment with 60 day course of oral GnRH antagonist
Subjects will be randomized to elagolix 200mg BID. The medication will be taken orally and subjects will be counseled to take the medication at the same time each day.
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Drug: Elagolix 200 MG
Elagolix tablet
Other Name: Orlissa |
Placebo Comparator: Pre-IVF Treatment with 60 day course of Placebo
Subjects will be randomized to placebo, BID. The medication will be taken orally and subjects will be counseled to take the medication at the same time each day.
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Drug: Placebo
Sugar pill manufactured to mimic Elagolix 200mg |
- Live birth rate [ Time Frame: Up to 15 months ]Live birth rate per participant is defined as live birth at ≥24 weeks of gestation.
- Live birth rate per transfer [ Time Frame: Up to 15 months ]Live birth rate per participant per ET cycle is defined as live birth at ≥24 weeks of gestation. (parity per transfer)

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Ages Eligible for Study: | 18 Years to 38 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women who plan to undergo IVF for treatment of infertility.
- Age ≥18 and <38 years at time of signing informed consent.
- 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.
- Body mass index (BMI) of 18-40 kg/m2 (both inclusive) at screening.
- AMH > 0.8 ng/ml, resulted within 6 months of planned IVF cycle start.
- Uterine cavity assessment by sonohysterogram or hysteroscopy within 6 months indicating absence of focal intracavitary pathology and hence adequacy for embryo transfer. Ultrasound features suggestive of adenomyosis will be acceptable for inclusion. Type 3 fibroids are allowed up to 4cm size
- Presence of at least one ovary with no clinically significant abnormalities other than endometrioma. For eligible subjects 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.
- Negative urine or cervical swab for gonorrhea and chlamydia within 12 months of screening.
- Willing and able to comply with trial procedures, including reporting of obstetrical outcomes after delivery.
Exclusion Criteria:
- Use of GnRH agonists or antagonists within 6 months of study start, unless the antagonist was a part of a regular IVF cycle.
- Use of depot medroxyprogesterone acetate (MPA) or birth control implants (e.g. Implanon® or Nexplanon®) within 10 months of study start.
- Continuous use of oral progestins (MPA, NETA) within 3 months of study start.
- Use of aromatase inhibitors, danazol or hormonal contraceptives (Including combined oral contraceptive pill, progestin-only pill, transdermal patch or contraceptive ring) within 1 month of study start.
- Pregnancy greater than 8 weeks in length within the last 6 months.
- Number of previous IVF/ICSI attempts ≥3
- Presence of hydrosalpinx measuring >2cm on ultrasound, untreated endometrial polyps or intrauterine adhesions.
- Abnormal cytology on a pap smear within last year. (CIN1 or HPV okay, CIN2 excluded unless treated and cleared, CIN3 excluded).
- History of malignancy within 5 years of the start of screening, except for treated basal cell carcinoma and squamous cell carcinoma of the skin.
- Any suicide attempts in last 1 year.
- Hypersensitivity to the study drugs.
- Planned surgical treatment of endometriosis or planned surgery in the abdominal-pelvic area within the duration of the trial.
- Untreated abnormal prolactin or TSH
- Any conditions that preclude pregnancy. -

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173169
Contact: Heping Zhang, PhD | 203-785-5185 | heping.zhang@yale.edu |
United States, Colorado | |
University of Colorado Department of Obstetrics & Gynecology | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Shannon Pretzel 303-724-5276 SHANNON.PRETZEL@CUANSCHUTZ.EDU | |
Principal Investigator: Nanette Santoro | |
United States, Connecticut | |
Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Luisa Coraluzzi 203-785-2164 luisa.coraluzzi@yale.edu | |
Principal Investigator: Hugn Taylor | |
United States, Illinois | |
Northwestern University Department of Obstetrics and Gynecology | Not yet recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Shriya Shah 312-503-3488 shriya.shah@northwestern.edu | |
Principal Investigator: Emily Jungheim | |
United States, Maryland | |
Johns Hopkins, Division of Reproductive Science and Women's Health Research | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Bhuchitra Singh 410-955-6771 bsingh10@jhmi.edu | |
Principal Investigator: James Segars | |
United States, North Carolina | |
UNC Fertility | Recruiting |
Raleigh, North Carolina, United States, 27617 | |
Contact: Jana Phillips 919-908-0000 ext 812 jlphilli@med.unc.edu | |
Principal Investigator: Steven Young |
Study Director: | Esther Eisenberg, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | |
Principal Investigator: | Hugh Taylor, MD | Yale University | |
Study Director: | Heping Zhang, PhD | Yale University | |
Study Director: | Nanette Santoro, MD | University of Colorado, Denver | |
Study Director: | Jared Robbins, MD | Northwestern University | |
Study Director: | Steven Young, MD, PhD | University of North Carolina |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT04173169 |
Other Study ID Numbers: |
2000027121 1R01HD100336-01 ( U.S. NIH Grant/Contract ) |
First Posted: | November 21, 2019 Key Record Dates |
Last Update Posted: | March 17, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | We have a plan to submit data and samples collected by the trial to NICHD DASH. The informed consent will include permission to bank these samples. The processes included initial data and documentation preparation (e.g., codebooks, protocols, informed consent for data sharing), data quality control, and submission. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Infertility Endometriosis |