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GnRH Antagonist

Pre-IVF GnRH Antagonist for Endometriosis-related Infertility (PREGnant Trial)

Q: How many different medical facilities are overseeing this clinical trial today?

Presently, this trial is enrolling patients at 6 sites. The sites are located in Baltimore, Aurora and Raleigh as well as 6 other locations. If you enroll, selecting the location nearest to you will help to minimize travel demands.

Q: How many people does this research project include?

That is correct, the listing on clinicaltrials.gov confirms that the research team is currently enrolling patients. The study, which was first advertised on March 15th, requires 814 individuals from 6 different locations.

Q: What have doctors most commonly prescribed Elagolix 200 MG for?

Elagolix 200 MG is an effective treatment for menorrhagia, ovulation induction therapy, and fibroid tumors.

Q: Are there other examples of Elagolix 200 MG being put to clinical use?

There are currently 55 clinical studies investigating Elagolix 200 MG, with 15 of them being in Phase 3. Many of the Phase 3 trials are based in Chicago, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>, but there are a total of 1922 locations running clinical trials for Elagolix 200 MG.

Q: Would this experiment be appropriate for an elderly subject?

According to the eligibility criteria for this clinical trial, patients must be between 18-40 years old. If the patient is not qualified for this trial, there are 23 other clinical trials that they could potentially participate in. If the patient is over 65, there are 72 other clinical trials.

Q: Has Elagolix 200 MG received FDA approval?

Elagolix 200 MG is Phase 3, so it has some clinical data to support its efficacy and multiple rounds of data supporting its safety--our team rates it a 3.

Q: Could I potentially join this medical study?

This clinical trial is looking for 814 participants that currently suffer from <a href="https://www.withpower.com/clinical-trials/infertility">infertility</a>. The ideal candidate should be between the ages of 18-40 and meet the following requirements: Be willing to comply with trial procedures, including reporting of obstetrical outcomes after delivery, have the intention of undergoing <a href="https://www.withpower.com/clinical-trials/ivf">IVF</a> treatment for infertility, have a documented diagnosis of <a href="https://www.withpower.com/clinical-trials/endometriosis">endometriosis</a>, have a BMI of 18-40 kg/m2, have an AMH of >= 0.5ng/ml, have no known uterine cavity abnormalities, have one ovary with no clinically significant abnormalities, and have negative results for gonorrhea and chlamydia.

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

Women who plan to undergo IVF for treatment of infertility.

Age ≥18 and <40 years at time of egg retrieval or signing informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 months

Awards & highlights

PREGnant Trial Summary

This trial will test if a GnRH antagonist can improve live birth rates in infertile women with endometriosis undergoing IVF.

Who is the study for?

Women aged 18-40 with diagnosed endometriosis planning IVF can join. They must have a BMI of 18-40, no severe uterine issues, at least one healthy ovary, and an AMH level over 0.5ng/ml within the last year. Exclusions include recent use of certain contraceptives or hormone treatments, more than two failed IVF attempts, untreated reproductive tract conditions, certain cancers in the past five years, planned pelvic surgeries during the trial period.Check my eligibility

What is being tested?

The study is testing if taking Elagolix (a GnRH antagonist) before starting IVF improves live birth rates for women with endometriosis compared to those who don't take it but undergo standard IVF treatment.See study design

What are the potential side effects?

Elagolix may cause side effects like hot flashes, headache, fatigue, insomnia and mood changes. It might also affect bone density leading to osteoporosis risk over long-term use.

PREGnant Trial Eligibility Criteria

Inclusion Criteria

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

Select...

Women who are planning to have In Vitro Fertilization (IVF) treatment for infertility will not be able to participate.

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.

Select...

You have a body mass index (BMI) between 18 and 40 kilograms per square meter.

Select...

My uterus is healthy and has no major issues for embryo transfer.

Select...

I have at least one healthy ovary, possibly with an endometrioma.

Select...

You are willing and able to comply with trial procedures, including reporting of obstetrical outcomes after delivery.

Select...

You are a woman who is planning to have in vitro fertilization (IVF) to help with infertility.

Select...

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

Select...

My AMH level is above 0.5ng/ml, or I have a high-quality blastocyst for FET.

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 they 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 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,848 Previous Clinical Trials

2,737,418 Total Patients Enrolled

14 Trials studying Infertility

95,963 Patients Enrolled for Infertility

Northwestern UniversityOTHER

1,585 Previous Clinical Trials

916,831 Total Patients Enrolled

6 Trials studying Infertility

2,060 Patients Enrolled for Infertility

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,964 Previous Clinical Trials

2,674,330 Total Patients Enrolled

32 Trials studying Infertility

16,659 Patients Enrolled for Infertility

Media Library

Elagolix (GnRH Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04173169 — Phase 3

Infertility Research Study Groups: Pre-IVF Treatment with 60 day course of oral GnRH antagonist, Pre-IVF Treatment with 60 day course of Placebo or SOC IVF

Infertility Clinical Trial 2023: Elagolix Highlights & Side Effects. Trial Name: NCT04173169 — Phase 3

Elagolix (GnRH Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04173169 — Phase 3

Infertility Patient Testimony for trial: Trial Name: NCT04173169 — Phase 3

Frequently Asked Questions

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

How many different medical facilities are overseeing this clinical trial today?

"Presently, this trial is enrolling patients at 6 sites. The sites are located in Baltimore, Aurora and Raleigh as well as 6 other locations. If you enroll, selecting the location nearest to you will help to minimize travel demands."

Answered by AI

How many people does this research project include?

"That is correct, the listing on clinicaltrials.gov confirms that the research team is currently enrolling patients. The study, which was first advertised on March 15th, requires 814 individuals from 6 different locations."

Answered by AI

What have doctors most commonly prescribed Elagolix 200 MG for?

"Elagolix 200 MG is an effective treatment for menorrhagia, ovulation induction therapy, and fibroid tumors."

Answered by AI

Are there other examples of Elagolix 200 MG being put to clinical use?

"There are currently 55 clinical studies investigating Elagolix 200 MG, with 15 of them being in Phase 3. Many of the Phase 3 trials are based in Chicago, Illinois, but there are a total of 1922 locations running clinical trials for Elagolix 200 MG."

Answered by AI

Would this experiment be appropriate for an elderly subject?

"According to the eligibility criteria for this clinical trial, patients must be between 18-40 years old. If the patient is not qualified for this trial, there are 23 other clinical trials that they could potentially participate in. If the patient is over 65, there are 72 other clinical trials."

Answered by AI

Has Elagolix 200 MG received FDA approval?

"Elagolix 200 MG is Phase 3, so it has some clinical data to support its efficacy and multiple rounds of data supporting its safety--our team rates it a 3."

Answered by AI

Could I potentially join this medical study?

"This clinical trial is looking for 814 participants that currently suffer from infertility. The ideal candidate should be between the ages of 18-40 and meet the following requirements: Be willing to comply with trial procedures, including reporting of obstetrical outcomes after delivery, have the intention of undergoing IVF treatment for infertility, have a documented diagnosis of endometriosis, have a BMI of 18-40 kg/m2, have an AMH of >= 0.5ng/ml, have no known uterine cavity abnormalities, have one ovary with no clinically significant abnormalities, and have negative results for gonorrhea and chlamydia."

Answered by AI

Who else is applying?

What state do they live in?

Illinois

Indiana

Connecticut

Other

How old are they?

18 - 65

What site did they apply to?

University of Colorado Department of Obstetrics & Gynecology

Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences

Other

Northwestern University Department of Obstetrics and Gynecology

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

We have tried 6 rounds of letrozole. I've been diagnosed with secondary infertility & was hoping to have another child.

PatientReceived no prior treatments

I am looking to try any new treatment as I would like to experience pregnancy at 52. I have a very good health conditions.Thanks.

PatientReceived 1 prior treatment

My first egg retrieval I only got 1 egg, even with Stims. I have waited my entire life to be a mother and I dream of making this happen.

PatientReceived 2+ prior treatments

Last year in May me and my husband was informed that i would have to have my tubes removed and the only way for us to have a baby was through IVF. We are currently saving up for IVF.

PatientReceived no prior treatments