Double GnRH Antagonist Daily Dose in Hyperresponding IVF/ICSI Cycles May Prevent the OHSS
1 other identifier
observational
38
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Feb 2009
Shorter than P25 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 30, 2011
CompletedFirst Posted
Study publicly available on registry
November 23, 2011
CompletedNovember 28, 2011
November 1, 2011
1 year
June 30, 2011
November 23, 2011
Conditions
Keywords
Eligibility Criteria
PILOT STUDY
You may qualify if:
- Women stimulated with the antagonist protocol who are at risk of ovarian hyperstimulation syndrome
You may not qualify if:
- Has chosen other preventive protocols (coasting and/or cryopreservation)were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Iakentro Fertility Centrelead
- Aristotle University Of Thessalonikicollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
June 30, 2011
First Posted
November 23, 2011
Study Start
February 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
November 28, 2011
Record last verified: 2011-11