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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
They are between the ages of 18 and 40.
They are undergoing IVF treatment with a GnRH antagonist protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days after the fertilization of oocyte
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Study Summary

This trial looks at whether using a "dual trigger" can improve IVF outcomes compared to GnRH agonist (GnRH-a) alone in patients at high 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 18 and 40 years old.
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You are currently receiving a specific type of treatment for infertility.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 days after oocyte retrieval
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 days after oocyte retrieval for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total number of Day 5 embryos
Secondary outcome measures
Clinical pregnancy rate
Fertilization rate
Implantation rate
+8 more

Side effects data

From 2006 Phase 4 trial • 166 Patients • NCT00249834
10%
Influenza
10%
Pneumonia
10%
Ovarian hyperstimulation syndrome
10%
Breast pain
10%
Headache
10%
Myasthenic syndrome
10%
Abdominal pain
10%
Pelvic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gonal-f 225 IU
Gonal-f 150 IU
Gonal-f 187.5 IU
Gonal-f 75 IU
Gonal-f 112.5 IU

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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).

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
193 Previous Clinical Trials
67,282 Total Patients Enrolled
Miguel Russo, MDPrincipal InvestigatorMount Sinai Hospital, Canada

Media Library

Pregnyl (Gonadotropin-releasing hormone agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05638529 — Phase 4
Female Infertility Research Study Groups: Treatment Arm- Group A, Control Arm- Group B
Female Infertility Clinical Trial 2023: Pregnyl Highlights & Side Effects. Trial Name: NCT05638529 — Phase 4
Pregnyl (Gonadotropin-releasing hormone agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05638529 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Treatment Arm-Group A attained regulatory approval from the FDA?

"With the completion of Phase 4 trials, Treatment Arm - Group A is rated at a 3 in terms of its safety profile."

Answered by AI

Does this trial accept participants under the age of 40?

"As detailed in the study's entry criteria, only those aged 18 - 40 are eligible to participate."

Answered by AI

Are there any opportunities for eligible participants to join this experiment?

"That is accurate. According to information featured on clinicaltrials.gov, this trial was initially posted on May 1st 2019 and has been actively searching for volunteers since then. The study requires 88 participants from one location only."

Answered by AI

Who is eligible to be a part of this clinical trial?

"This study seeks 88 female participants between 18 and 40 years old struggling with infertility. In order to qualify, applicants must be within the age bracket mentioned earlier and possess 13 or more follicles measuring at least 11 mm on trigger day, a serum estradiol level of 15,000 pmol/L during that same period, as well as currently engaging in an IVF program using GnRH antagonists."

Answered by AI

What is the upper limit for enrolment in this investigation?

"Affirmative. The information on clinicaltrials.gov affirms that this investigation is proactively searching for participants, starting from May 1st 2019 and last updated in December 2nd 2022. 88 patients are needed to be enrolled at one facility."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Mount Sinai Hospital, Fertility Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

May of 2022 me and my husband were informed that my fallopian tubes would have to be removed. The only way for us to have a child is ivf. We are currently saving to have the treatment.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Do you accept people that have to travel from the US?
PatientReceived no prior treatments
~14 spots leftby Feb 2025