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 : August 16, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Infertility Endometriosis||Drug: Elagolix 200 MG Other: Placebo or SOC IVF||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||814 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Half of the subjects (407, randomized or not randomized) will receive elagolix 200mg twice a day (BID) and the other half of subjects will receive placebo BID or SOC IVF (407, placebo or SOC IVF). Elagolix or placebo will be taken 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:||For participants who agree to be randomized, 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.|
|Official Title:||Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis - A Prospective Clinical Trial|
|Actual Study Start Date :||March 15, 2022|
|Estimated Primary Completion Date :||September 30, 2024|
|Estimated Study Completion Date :||September 30, 2024|
Active Comparator: Pre-IVF Treatment with 60 day course of oral GnRH antagonist
For those who agree to be randomized, 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. This arm will also include participants who do not want to be randomized while choose elagolix.
Drug: Elagolix 200 MG
Other Name: Orlissa
Pre-IVF Treatment with 60 day course of Placebo or SOC IVF
For those who agree to be randomized, 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. This arm will also include participants who want to continue their ongoing or planned IVF and follow standard of care (SOC) (SOC IVF) if they do not want to delay the IVF procedure.
Other: Placebo or SOC IVF
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.
- Fertilization rate [ Time Frame: Up to 9 months ]Fertilization rate per participant is defined as the rate of [two pronuclei (2PN)]/[total number of oocytes injected or inseminated]
- Number of embryos transferred [ Time Frame: Up to 9 months ]Number of embryos transferred per participant
- Implantation rate [ Time Frame: Up to 9 months ]Implantation rate per participant is defined as the rate of (number of gestation sacs visible by Ultrasound) / (Number of Embryo Transfer),
- Biochemical pregnancy rate [ Time Frame: Up to 9 months ]Biochemical pregnancy rate per participant is defined as positive pregnancy test following embryo transfer
- Clinical pregnancy rate [ Time Frame: Up to 10 months ]Clinical pregnancy rate per participant is defined as ultrasound evidence of intrauterine gestational sac with fetal cardiac activity
- Miscarriage rate [ Time Frame: Up to 10 months ]Miscarriage rate among those who achieved pregnancy. Miscarriage is defined as pregnancy loss prior to viability scan and including those confirmed on ultrasound scan up to ≤23+6 weeks of gestation gestation.
- Overall pregnancy complication rate [ Time Frame: Up to 15 months ]Overall pregnancy complication rate among those who achieved pregnancy. Overall pregnancy complication including any of the following: preterm delivery, preeclampsia, incidence of abnormal placentation (placenta previa, accreta, increta, percreta, abruption), bleeding in pregnancy (antepartum or postpartum)
- Gestation age at delivery [ Time Frame: Up to 15 months ]Gestation age (weeks) at delivery per infant delivered
- Infant birth weight [ Time Frame: Up to 15 months ]Infant birth weight (gram) per infant delivered.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 40 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Women who plan to undergo IVF for treatment of infertility.
- Age ≥18 and <40 years at time of egg retrieval or 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 >= 0.5ng/ml, within 12 months of egg collection for a FET or within 12 months of a fresh IVF cycle start.
- 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.
- 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.
- 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.
- 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.
- Use of depot medroxyprogesterone acetate (MPA) (injectable) or birth control implants (e.g., Implanon® or Nexplanon®) within 6 months of study start.
- Continuous use of oral progestins (MPA, NETA) within 1 month of study start.
- 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.
- Pregnancy greater than 8 weeks in length within the last 6 months.
- Number of previous IVF/ICSI attempts ≥3 unsuccessful (negative pregnancy test).
- Presence of hydrosalpinx measuring >2cm on ultrasound, untreated endometrial polyps or intrauterine adhesions.
- 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).
- 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 thoughts of suicide in the last 12 months per self-report, or documented in the electronic medical record (EMR).
- 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.
- Patients with a known history of a low-trauma fracture or other risk factors for osteoporosis or bone loss.
- Patients with cirrhosis or abnormal LFTs per self report or documented in the electronic medical record (EMR).
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, PhDfirstname.lastname@example.org|
|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: Michele Frank 203-785-6949 email@example.com|
|Principal Investigator: Hugn Taylor|
|United States, Illinois|
|Northwestern University Department of Obstetrics and Gynecology||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Shriya Shah 312-503-3488 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: James Segars|
|United States, North Carolina|
|Raleigh, North Carolina, United States, 27617|
|Contact: Tifani Panek 773-706-4202 firstname.lastname@example.org|
|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:||Emily Jungheim, MD||Northwestern University|
|Study Director:||Steven Young, MD, PhD||University of North Carolina|
|Responsible Party:||Yale University|
|Other Study ID Numbers:||
1R01HD100336-01 ( U.S. NIH Grant/Contract )
|First Posted:||November 21, 2019 Key Record Dates|
|Last Update Posted:||August 16, 2022|
|Last Verified:||August 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.|
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|