Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?
Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||An Uncontrolled, Open-label Feasibility Study to Demonstrate That a GnRH Agonist (Decapeptyl) Can be Safely Administered to Trigger Final Oocyte Maturation in High Responder Patients to Mitigate the Risk of OHSS|
- Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval. [ Time Frame: 12 day from GnRH agonist trigger day. ] [ Designated as safety issue: Yes ]OHSS usually occurs a few days following oocyte retrieval, and is not a threat once menses start.
- Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta. [ Time Frame: One month from embryo transfer date ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: OHSS high risk patients
Triptorelin 0.2 mg
Drug: Triptorelin 0.2 mg
A single bolus of 0.2 mg triptorelin given 34-36 hours before oocyte retrieval.
Other Name: Decapeptyl 0.2 mg
Administration of hCG (10.000 or 5.000 IU) is essential in IVF protocols to trigger final oocyte maturation after ovarian stimulation. In high responder patients with potential risk of developing OHSS, hCG is usually withheld and the treatment cycle is cancelled without obtaining (cryopreserved) embryos for replacement.
An alternative approach to trigger final oocyte maturation is to administer a GnRH agonist instead of hCG. This method is not possible following a long GnRH agonist protocol which causes down-regulation of the GnRH receptor. However, following GnRH antagonist treatment the GnRH receptor remains receptive to competitive binding by a GnRH agonist.
It has been well-described in earlier IVF trials that a bolus of GnRH agonist will displace the GnRH antagonist from the GnRH receptors in the pituitary inducing an endogenous LH (and FSH) surge resulting in the maturation of oocytes and good quality embryos. In addition, the risk of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) becomes minimal due to the rapid demise of the corpora lutea. Following luteolysis, fresh embryo transfer would require alternative luteal phase support to secure good clinical outcome. Alternatively, good quality embryos obtained after GnRH agonist triggering can be cryopreserved and replaced in following frozen-thawn embryo transfer (FTET) cycles. Thus, also eliminating late onset OHSS due to pregnancy.
|Contact: Shahar Kol, MDemail@example.com|
|Contact: Joseph Itskovitz, MDfirstname.lastname@example.org|
|IVF Unit, Elisha Hospital||Recruiting|
|Haifa, Israel, 31064|
|Contact: Shahar Kol, MD 972502064126 email@example.com|
|Contact: Joseph Itskovitz, MD 972502062035 firstname.lastname@example.org|
|Principal Investigator: Shahar Kol, MD|
|Principal Investigator:||Shahar Kol, MD||Elisha Hospital, Haifa, Israel|