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NCT05638529
Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome
Conditions: Ovarian Hyperstimulation Syndrome, Infertility, Female
Sex: Female
Ages: 18 Years – 40 Years
Phase: PHASE4
Enrollment: 88
Sponsor: Mount Sinai Hospital, Canada
Location: Canada
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.
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
Source: ClinicalTrials.gov (NCT05638529). StuddyBuddy aggregates publicly available trial information.