RECRUITING

Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis - A Prospective Clinical Trial

Quick Facts

Study Start:2024-03-16

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06375811

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Heping Zhang, PhD

CONTACT

203-785-5185

heping.zhang@yale.edu

Principal Investigator

Hugh Taylor, MD

PRINCIPAL_INVESTIGATOR

Yale University

Heping Zhang, PhD

STUDY_DIRECTOR

Yale University

Nanette Santoro, MD

STUDY_DIRECTOR

University of Colorado, Denver

Emily Jungheim, MD

STUDY_DIRECTOR

Northwestern University

Steven Young, MD, PhD

STUDY_DIRECTOR

Duke University

Jim Segars, MD

STUDY_DIRECTOR

Johns Hopkins University

Study Locations (Sites)

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

Northwestern University Department of Obstetrics and Gynecology

Chicago, Illinois, 60611

United States

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

Baltimore, Maryland, 21205

United States

Duke Fertility

Morrisville, North Carolina, 27560

United States

Collaborators and Investigators

Sponsor: Yale University

Hugh Taylor, MD, PRINCIPAL_INVESTIGATOR, Yale University
Heping Zhang, PhD, STUDY_DIRECTOR, Yale University
Nanette Santoro, MD, STUDY_DIRECTOR, University of Colorado, Denver
Emily Jungheim, MD, STUDY_DIRECTOR, Northwestern University
Steven Young, MD, PhD, STUDY_DIRECTOR, Duke University
Jim Segars, MD, STUDY_DIRECTOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-16

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-03-16

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

Infertility
Endometriosis