Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?
|ClinicalTrials.gov Identifier: NCT01714648|
Recruitment Status : Terminated (Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated)
First Posted : October 26, 2012
Last Update Posted : August 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Hyperstimulation Syndrome||Drug: Triptorelin 0.2 mg||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
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
- 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. ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714648
|IVF Unit, Elisha Hospital|
|Haifa, Israel, 31064|
|Principal Investigator:||Shahar Kol, MD||Elisha Hospital, Haifa, Israel|