What is the mechanism of action of this treatment?

GnRH antagonists inhibit GnRH receptors in the pituitary gland, preventing the release of gonadotropins (LH and FSH) and subsequently reducing estrogen production. This mechanism is particularly beneficial for managing endometriosis, a condition that can impair fertility. By understanding how these treatments regulate hormonal imbalances and improve ovarian function, infertility patients can make informed decisions about their treatment options to enhance their chances of successful conception.

What side effects are associated with this type of intervention?

Common treatments for infertility, such as oral GnRH antagonists, can have several side effects. These include menopausal symptoms like hot flashes, headaches, mood swings, and decreased bone density due to reduced estrogen levels. Other hormonal treatments, such as GnRH agonists, may also cause similar menopausal symptoms and carry a risk of osteoporosis with prolonged use. Additionally, treatments like oral contraceptives and progestins can lead to side effects such as weight gain, nausea, and breast tenderness. It is important to discuss these potential side effects with a healthcare provider to weigh the benefits and risks of each treatment option.

What prior FDA approvals exist?

FDA-approved treatments for infertility often involve the use of gonadotropin-releasing hormone (GnRH) agonists and antagonists. GnRH agonists, such as leuprolide, goserelin, and buserelin, are used to control ovarian stimulation by initially increasing and then suppressing gonadotropin release. GnRH antagonists, like cetrorelix and ganirelix, directly inhibit gonadotropin release without the initial surge, providing a more immediate suppression of hormone levels. These treatments help manage conditions like endometriosis and improve outcomes in assisted reproductive technologies such as in vitro fertilization (IVF).

What other types of research exist?

Promising novel alternatives to oral GnRH antagonists for infertility patients in 2024 include aromatase inhibitors (e.g., letrozole), which reduce estrogen production and have shown efficacy in managing endometriosis symptoms. Another option is selective estrogen receptor modulators (SERMs) like clomiphene citrate, which can induce ovulation and improve fertility. These alternatives offer different mechanisms of action and may be suitable for patients who do not respond well to GnRH antagonists.

← Back to Search

GnRH Antagonist

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

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

Pivotal Trial

Summary

This trial tests a pill that helps women with endometriosis who are undergoing IVF. These women often have lower success rates with IVF, and the pill helps manage hormone levels to improve their chances of having a baby.

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Live birth rate

Secondary study objectives

Biochemical pregnancy rate

Clinical pregnancy rate

Fertilization rate

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GnRH antagonists inhibit GnRH receptors in the pituitary gland, preventing the release of gonadotropins (LH and FSH) and subsequently reducing estrogen production. This mechanism is particularly beneficial for managing endometriosis, a condition that can impair fertility. By understanding how these treatments regulate hormonal imbalances and improve ovarian function, infertility patients can make informed decisions about their treatment options to enhance their chances of successful conception.

Metformin treatment before and during IVF or ICSI in women with polycystic ovary syndrome.GnRH-antagonists in reproductive medicine.Treatment of uterine fibroids with a slow-release formulation of the gonadotrophin releasing hormone antagonist Cetrorelix.