Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome (NCT05638529) | Clinical Trial Compass
UnknownPhase 4
Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome
Canada80 participantsStarted 2019-05-01
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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