What side effects are associated with this type of intervention?

Common treatments for Ovarian Hyperstimulation Syndrome (OHSS) include the use of GnRH agonists and human chorionic gonadotropin (hCG) for ovulation triggering. The 'dual trigger' approach, which combines GnRH agonists and hCG, aims to improve oocyte maturation and embryo quality. Known side effects of these treatments can include abdominal pain, bloating, nausea, vomiting, and, in severe cases, rapid weight gain, shortness of breath, and blood clots. It is important to monitor patients closely to manage these potential side effects effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Ovarian Hyperstimulation Syndrome (OHSS), focusing on reducing the risk and managing symptoms. One notable approach is the use of gonadotropin-releasing hormone (GnRH) agonists and antagonists to trigger ovulation, which can help mitigate the risk of OHSS. For instance, GnRH agonists like leuprolide acetate are used to induce final oocyte maturation in high-risk patients. Additionally, cabergoline, a dopamine agonist, has been approved to prevent OHSS by reducing vascular permeability. The 'Dual Trigger' method, which combines GnRH agonist with low-dose human chorionic gonadotropin (hCG), is being studied for its potential to improve oocyte quality and embryo potential while minimizing OHSS risk.

What other types of research exist?

Promising alternatives to the Dual Trigger approach for OHSS patients include: 1) GnRH agonist trigger alone, which reduces the risk of OHSS by inducing a shorter luteinizing hormone surge; 2) Use of letrozole during ovarian stimulation to lower estrogen levels and reduce OHSS risk; 3) Freeze-all strategy, where all embryos are frozen for later transfer, avoiding fresh transfer cycles that can exacerbate OHSS; 4) Low-dose hCG trigger combined with GnRH agonist to balance oocyte maturation and OHSS risk. These methods focus on optimizing outcomes while minimizing the risk of OHSS.

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Gonadotropin-releasing hormone agonist

Dual Trigger IVF for OHSS

Phase 4

Waitlist Available

Led By Miguel Russo, MD

Research Sponsored by Mount Sinai Hospital, Canada

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-5 days after the egg retrieval

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing a combination of two medications to improve egg quality in IVF for patients at high risk of complications. The goal is to retrieve more mature eggs without increasing the risk of OHSS.

Who is the study for?

This trial is for women aged 18-40 undergoing IVF with a risk of Ovarian Hyperstimulation Syndrome (OHSS). They must have at least 13 follicles or high estradiol levels on the day of trigger. Women who've had poor outcomes with dual triggers, low ovarian reserve, are preserving fertility due to cancer, have recurrent implantation failure, or certain medical conditions can't participate.

What is being tested?

The study tests if a 'dual trigger' (Pregnyl and saline) improves IVF outcomes compared to just GnRH agonist in patients at high OHSS risk. It focuses on oocyte quality and embryo potential by looking only at freeze-all cycles followed by frozen embryo transfers.

What are the potential side effects?

Possible side effects from Pregnyl may include reactions at the injection site, headache, restlessness, depression, fatigue, swelling from fluid retention and rarely hyperstimulation of the ovaries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 5 days of oocyte fertilization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 5 days of oocyte fertilization

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 5 days of oocyte fertilization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Total number of Day 5 embryos

Secondary study objectives

Clinical pregnancy rate

Fertilization rate

Implantation rate

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment Arm- Group AExperimental Treatment1 Intervention

A subcutaneous injection of a GnRH agonist (Suprefact 0.5 mg) and a separate intramuscular injection of hCG (Pregnyl 1,500 IU).

Group II: Control Arm- Group BPlacebo Group1 Intervention

A subcutaneous injection of a GnRH agonist (Suprefact 0.5 mg) and a separate intramuscular injection of normal saline (1.5 mL) (sham-placebo).

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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

The most common treatments for Ovarian Hyperstimulation Syndrome (OHSS) include the use of GnRH agonists, hCG, and dopamine agonists. GnRH agonists help by reducing the risk of OHSS through a shorter half-life and less luteal phase support compared to hCG. hCG is used to trigger ovulation but can increase the risk of OHSS due to its longer half-life. Dopamine agonists, such as cabergoline, reduce vascular permeability and thus the severity of OHSS. The 'Dual Trigger' approach, which combines LH and FSH, aims to improve oocyte maturation and embryo quality while potentially reducing the risk of OHSS by optimizing the hormonal environment. This matters for OHSS patients as it can enhance treatment outcomes and minimize complications associated with excessive ovarian stimulation.

Combined gonadotropin releasing hormone agonist/human menopausal gonadotropin therapy (GnRH-a/hMG) in normal, high, and poor responders to hMG.