350 Participants Needed

GnRH Agonist for Infertility

PG
Overseen ByPeter G McGovern, MD
Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: University Reproductive Associates
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that GnRH Agonist for Infertility is an effective treatment?

The available research shows that GnRH agonists are effective in improving pregnancy and live birth rates, especially in women with polycystic ovary syndrome (PCOS) undergoing in vitro fertilization (IVF). They are used in a 'long protocol' before other fertility drugs, which has consistently shown better outcomes. However, GnRH antagonists, a different type of treatment, are becoming more popular because they offer similar success rates with shorter treatment times and fewer side effects. This suggests that while GnRH agonists are effective, there might be more convenient alternatives available.12345

What safety data is available for GnRH agonists used in infertility treatment?

GnRH agonists, also known by names like LHRH and Gonadorelin, have been studied primarily in the context of prostate cancer treatment. Some studies suggest they may have a higher risk of adverse events compared to other therapies, such as antiandrogens or GnRH antagonists, particularly concerning cardiovascular risks. However, these findings are not consistent across all studies. In terms of fertility treatments, GnRH antagonists have been shown to be safe with no adverse effects on offspring in animal studies, and careful study of pregnancy outcomes in humans is recommended. Overall, GnRH analogues are considered safe and effective in clinical settings, though they may have specific safety considerations like initial flare-ups in prostate cancer treatment.678910

Is the drug used in the trial titled 'GnRH Agonist for Infertility' a promising treatment?

Yes, the drug used in the trial is promising for treating infertility. GnRH agonists help control ovarian stimulation, which is important in assisted reproductive technology. They have shown positive results in improving pregnancy outcomes and are considered valuable in reproductive treatments.311121314

What is the purpose of this trial?

During IVF cycles an embryo is generally placed into the uterine cavity between 3 and 5 days after fertilization. For a successful pregnancy to take place, that embryo must then implant in the properly primed and staged endometrium, which subsequently must continue to develop to accommodate the growing and maturing embryo and then fetus. This process is normally regulated by hormonal interactions between the fetal, endometrial and luteal tissue. It has been found that after IVF additional support for the endometrium with progesterone improves implantation and subsequent live birth rates in IVF cycle . Recent data has shown that additional supplementation with a single administration of a GnRH agonist around the time the time of embryo transfer may further enhance these rates .

Research Team

PG

Peter G McGovern, MD

Principal Investigator

Rutgers University

Eligibility Criteria

This trial is for women under 40 years old undergoing IVF, ICSI, or frozen embryo transfers to help with infertility. It's not for those having an embryo transfer on day 3 of the process.

Inclusion Criteria

I am a woman under 40 planning to undergo IVF/ICSI or FET.

Exclusion Criteria

Day 3 transfers

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a GnRH agonist or placebo around the time of embryo transfer to support endometrial development

1 week

Follow-up

Participants are monitored for implantation success and pregnancy outcomes

12 weeks

Treatment Details

Interventions

  • GnRH
Trial Overview The study tests if a single dose of GnRH agonist given around the time of embryo transfer improves implantation and live birth rates in IVF cycles compared to a placebo.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GnRH agonistExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Reproductive Associates

Lead Sponsor

Trials
6
Recruited
460+

Findings from Research

In a study of 40 women with previous IVF or ICSI failures, using the GnRH antagonist cetrorelix led to a significantly higher number of patients developing at least one expanded blastocyst compared to the GnRH agonist protocol (25 vs. 9).
The cetrorelix protocol resulted in a pregnancy rate of 42.1%, with 16 women becoming pregnant, indicating that this approach may enhance pregnancy outcomes by improving blastocyst quality in patients with a history of unsuccessful treatments.
GnRH antagonist improved blastocyst quality and pregnancy outcome after multiple failures of IVF/ICSI-ET with a GnRH agonist protocol.Takahashi, K., Mukaida, T., Tomiyama, T., et al.[2019]
GnRH antagonists, such as cetrorelix and ganirelix, provide a promising alternative to traditional GnRH agonists for preventing premature LH surges during ovarian stimulation, with comparable clinical outcomes and reduced treatment times.
These antagonists are associated with a lower risk of ovarian hyperstimulation syndrome (OHSS) and are preferred by patients over agonist treatments, indicating their potential to become the preferred choice in assisted reproductive techniques.
The place of gonadotrophin-releasing hormone antagonists in reproductive medicine.Howles, CM.[2019]
GnRH agonists are essential for enhancing the effectiveness of gonadotrophins in ovulation induction during assisted reproduction, indicating their critical role in fertility treatments.
Long regimens of GnRH agonists are particularly effective, as they help optimize patient scheduling and improve clinical outcomes in assisted reproductive technologies.
Role of different GnRH agonist regimens in pituitary suppression and the outcome of controlled ovarian hyperstimulation.Filicori, M., Cognigni, GE., Arnone, R., et al.[2019]

References

GnRH antagonist improved blastocyst quality and pregnancy outcome after multiple failures of IVF/ICSI-ET with a GnRH agonist protocol. [2019]
The place of gonadotrophin-releasing hormone antagonists in reproductive medicine. [2019]
Role of different GnRH agonist regimens in pituitary suppression and the outcome of controlled ovarian hyperstimulation. [2019]
Use of luteinizing hormone releasing hormone agonists in polycystic ovary syndrome. [2019]
Optimal usage of the GnRH antagonists: a review of the literature. [2022]
Androgen Deprivation Therapies and Changes in Comorbidity: A Comparison of Gonadotropin-releasing Hormone Agonists and Antiandrogen Monotherapy as Primary Therapy in Men with High-risk Prostate Cancer. [2019]
Cardiovascular Risk in Prostate Cancer Patients Using Luteinizing Hormone-Releasing Hormone Agonists or a Gonadotropin-Releasing Hormone Antagonist. [2023]
Single dose responses to the gonadotropin-releasing hormone agonist analogue [(imBz 1)-D-His6,Pro9-NEt]GnRH. [2013]
Perinatal outcome of pregnancy after GnRH antagonist (ganirelix) treatment during ovarian stimulation for conventional IVF or ICSI: a preliminary report. [2019]
Clinical pharmacology and regulatory consequences of GnRH analogues in prostate cancer. [2022]
[GnRH analogs in gynecology. Possibilities for therapeutic use]. [2006]
Comparison of pregnancy outcome in half-dose Triptorelin and short-acting Decapeptyl in long protocol in ART cycles: A randomized clinical trial. [2021]
13.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Non-peptidic GnRH receptor antagonists. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Clinical applications of gonadotropin-releasing hormones in reproductive disorders. [2006]
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