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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The present study aims to evaluate whether the use of a "dual trigger" can improve IVF outcomes, compared to GnRH agonist (GnRH-a) alone, in patients at high risk of OHSS undergoing a freeze-all cycle. By examining freeze-all cycles with frozen embryo transfer(s) (FET) only, we eliminate the potential confounding issue of inadequate luteal support to the endometrium and focus primarily on the effect of a "dual trigger" on oocyte quality and embryo potential.

To our best knowledge, there have been no randomized, controlled trials conducted to address this hypothesis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mount Sinai Hospital, Canada
• Treatments: Chorionic Gonadotropin

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