Trial | NCT01714648  Report issue

Title

Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    triptorelin ...

  • Study Participants

    6
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.
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 Started
Nov 30
2012
Primary Completion
Jan 31
2014
Study Completion
Jan 31
2014
Last Update
Aug 04
2015
Estimate

Drug Triptorelin 0.2 mg

A single bolus of 0.2 mg triptorelin given 34-36 hours before oocyte retrieval.

  • Other names: Decapeptyl 0.2 mg

OHSS high risk patients Experimental

Triptorelin 0.2 mg

Criteria 

Inclusion Criteria:

A female patient who needs IVF to become pregnant.
Regular menstrual cycle.
Antral follicular count (AFC) > 18
Following treatment with follitropin beta more than 18 follicles ≥ 11 mm will develop.

Exclusion Criteria:

Hypersensitivity to the active substance or to any of the medications used.
Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
Pregnancy.
Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
Primary ovarian failure.
Ovarian cysts or enlarged ovaries.
A history of Ovarian Hyperstimulation Syndrome (OHSS).
A previous COS cycle that resulted in more than 30 follicles > 11 mm measured by ultrasound examination.
Fibroid tumours of the uterus incompatible with pregnancy.
Malformations of the reproductive organs incompatible with pregnancy
No Results Posted