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 range
18 Years – 40 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.