Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist
NCT ID: NCT01347268
Last Updated: 2011-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2011-01-31
2012-12-31
Brief Summary
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Detailed Description
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Purpose: To compare the decreased levels of estradiol (E2), coasting days, severity of OHSS and pregnancy outcomes of cycles in which GnRH agonist withdrawing with cycles in which the GnRH antagonist administration in patients at risk of severe OHSS.
Methods: a prospective randomized study was designed to evaluate clinical and endocrine outcome in two different coasting protocols. Women (n=120) under controlled ovarian hyperstimulation with GnRH agonist protocol at the risk of OHSS (≧20 follicles \>12 mm development with E2\> 4000 pg/ml) randomized into two groups. Group I (n=60), withdrawing GnRH agonists and continued low dose r-FSH 75 IU. Group II (n=60), GnRH antagonist administration and continued low dose r-FSH 75 IU. When E2\< 3000 pg/ml, hCG was given. Oocyte retrieval was performed 36 h after hCG administration. The primary outcome measures were the decreased levels of estradiol (E2) and the days of coasting. The secondary outcome measures were number of oocytes retrieved, pregnancy rate and the incidence of OHSS.
anticipated results: No significant differences were seen in the levels of estradiol (E2) decreased, the days of coasting, number of oocytes, pregnancy rate and the incidence of OHSS. GnRH antagonist is not necessary in coasting treatment while stop GnRH agonist.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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withdrawing GnRH agonists
withdrawing GnRH agonists
withdrawing GnRH agonists and continued low dose r-FSH 75 IU
GnRH antagonist administration
GnRH antagonist
GnRH antagonist administration and continued low dose r-FSH 75 IU
Interventions
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GnRH antagonist
GnRH antagonist administration and continued low dose r-FSH 75 IU
withdrawing GnRH agonists
withdrawing GnRH agonists and continued low dose r-FSH 75 IU
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
38 Years
FEMALE
Yes
Sponsors
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Shin Kong Wu Ho-Su Memorial Hospital
OTHER
Responsible Party
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Shin-Kong Wu Ho-Su Memorial Hospital
Principal Investigators
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Jiann-Loung Hwang, MD
Role: STUDY_CHAIR
Shin-Kong Wu Ho-Su Memerial Hospital
Locations
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Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memerial Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SKH-8302-100-DR-08
Identifier Type: -
Identifier Source: org_study_id
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