Double GnRH Antagonist Daily Dose in Hyperresponding IVF/ICSI Cycles May Prevent the OHSS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01477970
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : November 28, 2011
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
Yannis Prapas, Iakentro Fertility Centre

Brief Summary:

The possibility to prevent the early ovarian hyperstimulation syndrome (OHSS) by doubling the daily dose of GnRH-antagonist in women stimulated with the antagonist protocol who are at risk for OHSS was evaluated. Thirty-eight women of a study group who underwent ovarian stimulation using the GnRH-antagonist protocol and might have had their cycle cancelled because of OHSS were compared to 76 women of a control group. All cases of the study group were IVF women presenting a rapid rise of E2 ≥ 3500 pg/ml on the 7th day of stimulation or later while the follicles (> 12mm) were > 15 in total and the biggest one was ≤ 16mm in diameter. By decreasing the rFSH dose to 100IU a day and adding an additional dose of GnRH-antagonist (0.25 twice a day), estradiol levels were lowered or reached a plateau before hCG was given. A marked decrease or plateau of estradiol levels was observed the day of oocyte retrieval while the pregnancy rate was not adversely affected when compared with an optimum ovarian response cycles. None of the women were cancelled or developed OHSS.

In overresponding IVF cycles, doubling the usual GnRH-antagonist daily-dose during the ovarian stimulation, the estradiol rise could be blocked while a minimal follicular stimulation may continue without the risk of OHSS or adversely affect pregnancy rate.

Condition or disease
Ovarian Hyperstimulation Syndrome

Study Type : Observational
Actual Enrollment : 38 participants
Time Perspective: Prospective
Study Start Date : February 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  • Women stimulated with the antagonist protocol who are at risk of ovarian hyperstimulation syndrome

Exclusion Criteria:

  • Has chosen other preventive protocols (coasting and/or cryopreservation)were excluded

Responsible Party: Yannis Prapas, Associated Professor, Iakentro Fertility Centre Identifier: NCT01477970     History of Changes
Other Study ID Numbers: abcd1234
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: November 28, 2011
Last Verified: November 2011

Keywords provided by Yannis Prapas, Iakentro Fertility Centre:
GnRH antagonists
ovarian stimulation

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases