Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist
|ClinicalTrials.gov Identifier: NCT01347268|
Recruitment Status : Unknown
Verified January 2011 by Shin Kong Wu Ho-Su Memorial Hospital.
Recruitment status was: Recruiting
First Posted : May 4, 2011
Last Update Posted : May 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|In Vitro Fertilization||Procedure: GnRH antagonist Procedure: withdrawing GnRH agonists||Phase 4|
Background: Elevated estradiol (E2) levels and multiple folliculogenesis predispose to development of ovarian hyperstimulation syndrome (OHSS). In patients with GnRH agonist protocol, both withdrawing GnRH agonist and GnRH antagonist administration are associated with a reduction in (E2) levels with subsequent decreasing the incidence and severity of OHSS. This work is to compare the clinical and endocrine outcome response of cycles in which GnRH agonist withdrawing with cycles in which the GnRH antagonist administration in patients at risk of severe OHSS.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Study Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist Administration in Patients at Risk for Severe OHSS|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||December 2012|
|Experimental: withdrawing GnRH agonists||
Procedure: withdrawing GnRH agonists
withdrawing GnRH agonists and continued low dose r-FSH 75 IU
|Experimental: GnRH antagonist administration||
Procedure: GnRH antagonist
GnRH antagonist administration and continued low dose r-FSH 75 IU
- decreased levels of estradiol (E2) [ Time Frame: one year ]
- The days of coasting [ Time Frame: one year ]The interval between the day of starting intervention and the day of hCG administration
- number of oocytes retrieved [ Time Frame: one year ]
- pregnancy rate [ Time Frame: one year ]
- the incidencess of OHSS [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347268
|Contact: Jiann-Loung Hwang, MD||886-2-28332211 ext firstname.lastname@example.org|
|Contact: Heng-Ju Chen, MD||886-2-28332211 ext email@example.com|
|Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memerial Hospital||Recruiting|
|Contact: Jiann-Loung Hwang, MD 886-2-28332211 ext 3879 firstname.lastname@example.org|
|Contact: Heng-Ju Chen, MD 886-2-28332211 ext 3870 email@example.com|
|Study Chair:||Jiann-Loung Hwang, MD||Shin-Kong Wu Ho-Su Memerial Hospital|