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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
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 belowSelect...
You are between 18 and 40 years old.
Select...
You are currently receiving a specific type of treatment for infertility.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-3 days after oocyte retrieval
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 days after oocyte retrieval
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 moreSide effects data
From 2006 Phase 4 trial • 166 Patients • NCT0024983410%
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
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
196 Previous Clinical Trials
67,528 Total Patients Enrolled
Miguel Russo, MDPrincipal InvestigatorMount Sinai Hospital, Canada
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have tried to get pregnant multiple times, but have not been successful after transferring more than 4 healthy embryos.If your blood estradiol levels are 28,000 pmol/L or higher on a specific dayYou have tried a specific type of medication called GnRH agonist trigger before, and it didn't work.They have been diagnosed with hypogonadotropic hypogonadism.You have had a bad reaction to GnRH agonist before.They are currently using sperm that was taken out through surgery.You have a uterine condition that changes the shape of your uterus.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.Your blood has high levels of estradiol.You are currently using a certain type of medication that makes it unsuitable for you to use another specific type of medication.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm- Group A
- Group 2: Control Arm- Group B
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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