Trials
Search / Trial NCT05638529

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

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

Trial Information

Current as of February 05, 2025

Active, not recruiting

Keywords

Oocyte Maturity Dual Trigger Infertility, Female

ClinConnect Summary

While the use of GnRH-a trigger has nearly eliminated the risk of OHSS, several studies have shown that this strategy may be associated with poorer IVF outcomes after a fresh embryo transfer (Engmann et al., 2008; Galindo et al., 2009; Melo et al., 2017; Sismanoglu et al., 2009; Youssef et al., 2014). These findings may be partly explained by an inadequate LH surge, following a GnRH-a trigger, and raises two separate concerns. The first concern is whether an inadequate LH surge can have an detrimental effect on luteal support following a fresh embryo transfer. The corpus luteum requires con...

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

Trial Officials

Miguel Russo, MD

Principal Investigator

Mount Sinai Hospital, Canada

About Mount Sinai Hospital, Canada

Mount Sinai Hospital, located in Canada, is a leading academic health institution renowned for its commitment to innovative research and high-quality patient care. As a sponsor of clinical trials, Mount Sinai Hospital leverages its extensive expertise in various medical disciplines to advance clinical knowledge and develop new therapies. The hospital collaborates with a diverse network of healthcare professionals, researchers, and institutions to conduct rigorous trials that aim to improve health outcomes and enhance the quality of life for patients. With a focus on ethical standards and patient safety, Mount Sinai Hospital is dedicated to translating scientific discoveries into effective clinical practices.

Locations

Toronto, Ontario, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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