80 Participants Needed

Dual Trigger IVF for OHSS

MR
RL
EG
Overseen ByEllen Greenblatt, MD
Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Mount Sinai Hospital, Canada
Must be taking: GnRH antagonist
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.12678

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.127910

Who Is on the Research Team?

MR

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.
See 1 more

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.
See 8 more

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?
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).

Find a Clinic Near You

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.
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

[Ovulation induction in high risk IVF patients: GnRH-agonist, diminished dose of urinary or recombinant chorion gonadotropin]. [2016]
Combined ovulation triggering with GnRH agonist and hCG in IVF patients. [2017]
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]
Ovarian hyperstimulation syndrome following GnRH agonist trigger-think ectopic. [2018]
Dual Trigger with Gonadotropin Releasing Hormone Agonist and Human Chorionic Gonadotropin of Fresh Autologous Cycles in High Responders: A Systematic Review. [2022]
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]
GnRH antagonist rescue of a long-protocol IVF cycle and GnRH agonist trigger to avoid ovarian hyperstimulation syndrome: three case reports. [2011]
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]
[Dual Cycle and Dual Channel Regimen in the Treatment of Severe Ovarian Hyperstimulation Syndrome with Pregnancy]. [2018]
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]
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