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GnRH Antagonist

Pre-IVF Treatment with 60 day course of oral GnRH antagonist for Infertility (PREGnant Trial)

Q: What are the potential risks associated with administering a 60-day course of oral GnRH antagonist as part of Pre-IVF treatment?

<p>As per Power team's evaluation, the safety of Pre-<a href="https://www.withpower.com/clinical-trials/ivf">IVF</a> Treatment involving a 60-day regimen of oral GnRH antagonist is rated at level 3 due to its Phase 3 trial status, indicating existing efficacy data and comprehensive safety records.</p>

Phase 3

Recruiting

Led By Hugh Taylor, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 months

Awards & highlights

PREGnant Trial Summary

This trial is testing a new medication given by mouth to women with endometriosis who are trying to get pregnant through IVF. The main goal is to see if the medication can increase the chances

Who is the study for?

This trial is for women with endometriosis who are struggling to get pregnant and planning to undergo IVF. Participants should not have received any hormonal treatments within the last three months.Check my eligibility

What is being tested?

The study tests if taking a GnRH antagonist called Elagolix before starting IVF can increase the chances of giving birth. Women in the trial will either receive Elagolix or a placebo (a pill without active medication).See study design

What are the potential side effects?

Elagolix may cause side effects like headache, nausea, insomnia, anxiety, reduced bone density, hot flashes, mood changes, and menstrual irregularities.

PREGnant Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 40 years old.

Select...

My endometriosis was confirmed by surgery or pathology within the last 10 years, or I have an ovarian cyst linked to endometriosis.

PREGnant Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Live birth rate

Secondary outcome measures

Biochemical pregnancy rate

Clinical pregnancy rate

Fertilization rate

+6 more

PREGnant Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pre-IVF Treatment with 60 day course of Placebo or SOC IVFExperimental Treatment1 Intervention

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 the participants do not want to delay the IVF procedure.

Group II: Pre-IVF Treatment with 60 day course of oral GnRH antagonistActive Control1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North CarolinaOTHER

168 Previous Clinical Trials

1,450,034 Total Patients Enrolled

4 Trials studying Infertility

982 Patients Enrolled for Infertility

Johns Hopkins UniversityOTHER

2,267 Previous Clinical Trials

14,837,259 Total Patients Enrolled

3 Trials studying Infertility

242 Patients Enrolled for Infertility

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,273 Total Patients Enrolled

15 Trials studying Infertility

96,363 Patients Enrolled for Infertility

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to partake in this clinical investigation?

"To be considered for this research, individuals must demonstrate infertility and fall between the ages of 18 and 40. The trial aims to enroll approximately 288 eligible participants."

Answered by AI

Does this clinical trial include individuals who are 85 years of age or older?

"To be eligible for this research, individuals must be aged between 18 and 40. There are separate ongoing investigations tailored to those below 18 years old (totaling 18 studies) and individuals above 65 years of age (comprising a total of 63 studies)."

Answered by AI

What is the total number of participants being recruited for this research investigation?

"Affirmative. Information available on clinicaltrials.gov indicates that this trial is actively seeking participants. Initially shared on March 16, 2024, the posting was last modified on April 16, 2024. The aim is to recruit a total of 288 patients from five different locations."

Answered by AI

Is the current investigation open for participant enrollment?

"Indeed, according to the information available on clinicaltrials.gov, this current clinical trial is actively in search of eligible participants. It was initially posted on March 16th, 2024, and last revised on April 16th, 2024. The aim is to recruit a total of 288 patients from five distinct sites."

Answered by AI

In how many distinct settings is this research study being conducted?

"This study is being conducted at reputable institutions including Yale School of Medicine Department of Obstetrics, Gynecology & Reproductive Sciences in New Haven, Connecticut; Northwestern University's Department of Obstetrics and Gynecology in Chicago, Illinois; and Johns Hopkins' Division of Reproductive Science and Women's Health Research in Baltimore, Maryland. Additionally, there are five more locations participating in this trial."

Answered by AI

What are the potential risks associated with administering a 60-day course of oral GnRH antagonist as part of Pre-IVF treatment?

"As per Power team's evaluation, the safety of Pre-IVF Treatment involving a 60-day regimen of oral GnRH antagonist is rated at level 3 due to its Phase 3 trial status, indicating existing efficacy data and comprehensive safety records."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Heping Zhang 2024. "Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06375811.

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