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Dual Trigger IVF for OHSS
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2006 Phase 4 trial • 166 Patients • NCT00249834Trial Design
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- 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.
- Group 1: Treatment Arm- Group A
- Group 2: Control Arm- Group B
- 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.
- 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
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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