Dual Trigger IVF for OHSS

Overseen By Ellen Greenblatt, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Mount Sinai Hospital, Canada

Must be taking: GnRH antagonist

Must not be taking: GnRH agonist

Disqualifiers: Low ovarian reserve, Hypogonadotropic hypogonadism, Recurrent implantation failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3-5 days

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Dual Trigger IVF for OHSS safe for humans?

Research indicates that using a dual trigger approach in IVF, which involves a combination of medications like GnRH agonist and low dose hCG, can help prevent severe ovarian hyperstimulation syndrome (OHSS) in high-risk patients. While some cases of OHSS still occur, the studies suggest that this method is generally safe and can improve outcomes in IVF treatments. ^{1 2 3 4 5}

How does the drug Pregnyl differ from other treatments for OHSS?

Pregnyl, when used in a dual trigger approach with a GnRH agonist, helps reduce the risk of ovarian hyperstimulation syndrome (OHSS) by combining two mechanisms to trigger ovulation, which can improve pregnancy outcomes and reduce OHSS compared to using a GnRH agonist alone. ^{1 2 6 7 8}

What data supports the effectiveness of the dual trigger IVF treatment for OHSS?

Research shows that using a combination of a GnRH agonist and a reduced dose of hCG (dual trigger) in IVF can improve pregnancy rates and reduce the risk of ovarian hyperstimulation syndrome (OHSS) in high responders, compared to using hCG alone. ^{1 2 7 9 10}

Who Is on the Research Team?

Miguel Russo, MD

Principal Investigator

Mount Sinai Hospital, Canada

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are between 18 and 40 years old.

You are currently receiving a specific type of treatment for infertility.

You have a high risk for Ovarian Hyperstimulation Syndrome (OHSS) because you have a lot of large follicles in your ovaries.

Exclusion Criteria

They plan to use a "dual trigger" because a previous IVF cycle using a GnRH agonist trigger had poor results.

You have a low number of eggs in your ovaries.

You are currently getting treatment to save your ability to have children in the future.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 'dual trigger' or placebo comparator followed by oocyte retrieval and embryo transfer

3-5 days

Multiple visits for injections and monitoring

Follow-up

Participants are monitored for safety and effectiveness after embryo transfer, including assessment of pregnancy and live birth rates

10 months

Regular follow-up visits

Outcome Assessment

Assessment of live birth rate, OHSS incidence, and other secondary outcomes

Up to 20 weeks post-pregnancy confirmation

What Are the Treatments Tested in This Trial?

Interventions

• Normal Saline
• Pregnyl

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Arm- Group A Experimental Treatment 1 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 B Placebo Group 1 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).

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

Published Research Related to This Trial

The study aims to evaluate the safety and efficacy of using low dose hCG alongside GnRH agonist for oocyte maturation in 82 women undergoing IVF, focusing on preventing ovarian hyperstimulation syndrome (OHSS) and improving pregnancy rates.

By comparing two groups—one receiving low dose hCG at the trigger and placebo at retrieval, and the other receiving placebo at trigger and higher hCG at retrieval—the study will assess live birth rates and OHSS incidence, providing insights into optimal IVF protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS. Griffin, D., Benadiva, C., Budinetz, T., et al.[2020]

Citations

1. Bulgaria pubmed.ncbi.nlm.nih.gov

[Ovulation induction in high risk IVF patients: GnRH-agonist, diminished dose of urinary or recombinant chorion gonadotropin]. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Combined ovulation triggering with GnRH agonist and hCG in IVF patients. [2017]

3. England pubmed.ncbi.nlm.nih.gov

A simplified universal approach to COH protocol for IVF: ultrashort flare GnRH-agonist/GnRH-antagonist protocol with tailored mode and timing of final follicular maturation. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Ovarian hyperstimulation syndrome following GnRH agonist trigger-think ectopic. [2018]

5. Iran pubmed.ncbi.nlm.nih.gov

Dual Trigger with Gonadotropin Releasing Hormone Agonist and Human Chorionic Gonadotropin of Fresh Autologous Cycles in High Responders: A Systematic Review. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

GnRH antagonist administered twice the day before hCG trigger combined with a step-down protocol may prevent OHSS in IVF/ICSI antagonist cycles at risk for OHSS without affecting the reproductive outcomes: a prospective randomized control trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

GnRH antagonist rescue of a long-protocol IVF cycle and GnRH agonist trigger to avoid ovarian hyperstimulation syndrome: three case reports. [2011]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS. [2020]

9. China pubmed.ncbi.nlm.nih.gov

[Dual Cycle and Dual Channel Regimen in the Treatment of Severe Ovarian Hyperstimulation Syndrome with Pregnancy]. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A novel oocyte maturation trigger using 1500 IU of human chorionic gonadotropin plus 450 IU of follicle-stimulating hormone may decrease ovarian hyperstimulation syndrome across all in vitro fertilization stimulation protocols. [2022]