Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome

Launched by MOUNT SINAI HOSPITAL, CANADA · Dec 2, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a method called "dual trigger" to see if it can help improve outcomes for women undergoing in vitro fertilization (IVF) who are at high risk of developing a condition known as Ovarian Hyperstimulation Syndrome (OHSS). In this study, researchers are focusing on women who are undergoing what’s called a freeze-all cycle, where embryos are frozen for later use instead of being transferred immediately. By doing this, they can better understand how the dual trigger affects the quality of eggs and embryos without other factors getting in the way.

To be eligible for this trial, women must be between the ages of 18 and 40, be undergoing IVF with a specific treatment plan that uses a GnRH antagonist, and have certain risk factors for OHSS, such as having a certain number of mature follicles or high hormone levels on the day of treatment. Participants in the trial will receive close monitoring and care, and their experiences will help determine if this new approach can improve IVF success rates for those at risk of OHSS. This trial is currently active, but it is not recruiting new participants at this time.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • They are between the ages of 18 and 40.
• • They are undergoing IVF treatment with a GnRH antagonist protocol.
• * During their current treatment cycle, they have at least one of the following risk factors for OHSS:
• • Greater or equal to 13 follicles measuring at least 11 mm on the day of trigger.
• • Serum estradiol levels greater or equal to 15,000 pmol/L on the day of trigger.
• Exclusion Criteria:
• • They are using a GnRH agonist protocol (which is a contraindication to using a GnRH agonist trigger).
• • They are planning on using a "dual trigger" (based on poor outcomes in a previous IVF cycle using a GnRH agonist trigger).
• • They have a low ovarian reserve (AFC \< 7 follicles or AMH \< 10 pmol/L).
• • They have had a previous failed GnRH agonist trigger.
• • They have a known diagnosis of hypogonadotropic hypogonadism.
• • They have had a previous adverse or allergic reaction to GnRH agonist in the past.
• • They are using surgically retrieved sperm.
• • They are undergoing treatment for fertility preservation (oncofertility patients).
• • They have a history of recurrent implantation failure (defined as no clinical pregnancy after transfer of \> 4 good-quality embryos).
• • They have any congenital or acquire uterine anomalies distorting the uterine cavity.
• • If serum estradiol levels are equal or exceed 28,000 pmol/L on the day of trigger