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

This study has been completed.
Sponsor:
Collaborator:
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
Yannis Prapas, Iakentro Fertility Centre
ClinicalTrials.gov Identifier:
NCT01477970
First received: June 30, 2011
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

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
Ovarian Hyperstimulation Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Iakentro Fertility Centre:

Enrollment: 38
Study Start Date: February 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   25 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

PILOT STUDY

Criteria

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Yannis Prapas, Associated Professor, Iakentro Fertility Centre
ClinicalTrials.gov Identifier: NCT01477970     History of Changes
Other Study ID Numbers: abcd1234
Study First Received: June 30, 2011
Last Updated: November 23, 2011
Health Authority: Food and Drug Administration: Greece

Keywords provided by Iakentro Fertility Centre:
GnRH antagonists
OHSS
ovarian stimulation

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

ClinicalTrials.gov processed this record on July 20, 2014