Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist

Phase 4

• Conditions: In Vitro Fertilization
• Interventions: Procedure: withdrawing GnRH agonists; Procedure: GnRH antagonist

• Registration Number: NCT01347268
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Brief Summary

Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of ovulation induction and is a life threatening iatrogenic complication. 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.

Detailed Description

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 Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-05-02
• Last Update Submitted: 2011-05-02
• Study First Posted: 2011-05-04
• Last Update Posted: 2011-05-04
• Primary Completion: 2012-06
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• the risk of ovarian hyperstimulation syndrome

Exclusion Criteria

• allergic to GnRH antagonist

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
withdrawing GnRH agonists	withdrawing GnRH agonists	-
GnRH antagonist administration	GnRH antagonist	-

Primary Outcome Measures

Name	Time	Method
The days of coasting	one year	The interval between the day of starting intervention and the day of hCG administration
decreased levels of estradiol (E2)	one year

Secondary Outcome Measures

Name	Time	Method
number of oocytes retrieved	one year
the incidencess of OHSS	one year
pregnancy rate	one year

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memerial Hospital; 🇨🇳 Taipei, Taiwan