Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis (PREGnant)

  • STATUS
    Recruiting
  • End date
    Oct 17, 2024
  • participants needed
    814
  • sponsor
    Yale University
Updated on 17 June 2022
laparotomy
body mass index
cavities
cyst
cavity
laparoscopy
endometriosis
infertility
transvaginal ultrasound
gnrh antagonist
fibroids
hysteroscopy
adenomyosis
endometrioma
elagolix
anti-mullerian hormone
embryo transfer

Summary

A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist.

Description

Infertility is a common complication of endometriosis; while IVF successfully treats endometriosis-associated infertility, pregnancy rates are diminished compared to other etiologies of infertility. The study's long- term objectives are to better identify and treat endometriosis related infertility. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist. The use of gonadotropin releasing hormone (GnRH) agonist prior to IVF has been suggested to improve success, however studies have been small and rarely reported live birth rates. Further, use of this approach is limited by the long treatment time required. Recent approval of an oral GnRH antagonist for endometriosis provides a novel option for women with endometriosis who are undergoing IVF. This agent avoids parenteral administration and the prolonged delay in initiation of action as was seen with GnRH agonists. There have been no studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility. The investigators propose a clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. Participants will include those who agree to be randomized and those who do not want to be randomized. Those who agree to be randomized will be randomly assigned to either the elagolix group or placebo group. Those who do not want to be randomized can choose either the active treatment elagolix and follow the same procedures as those agreeing to be randomized or continue their ongoing or planned IVF and follow standard of care (SOC) (SOC IVF) if they do not want to delay the IVF procedure.

Details
Condition Infertility, Endometriosis
Treatment Placebo, Elagolix 200 MG, Placebo or SOC IVF
Clinical Study IdentifierNCT04173169
SponsorYale University
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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)
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