Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist

A Prospective Randomized Study Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist Administration in Patients at Risk for Severe OHSS

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.

Study Overview

• Status: Unknown
• Conditions: In Vitro Fertilization
• Intervention / Treatment: Procedure: withdrawing GnRH agonists; Procedure: GnRH antagonist

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jiann-Loung Hwang, MD; Phone Number: 3879 886-2-28332211; Email: m001015@ms.skh.org.tw
• Study Contact Backup: Name: Heng-Ju Chen, MD; Phone Number: 3870 886-2-28332211; Email: m004983@ms.skh.org.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memerial Hospital
    • Contact: Jiann-Loung Hwang, MD; Phone Number: 3879 886-2-28332211; Email: m001015@ms.skh.org.tw
    • Contact: Heng-Ju Chen, MD; Phone Number: 3870 886-2-28332211; Email: m004983@ms.skh.orh.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• the risk of ovarian hyperstimulation syndrome

Exclusion Criteria:

• allergic to GnRH antagonist

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decreased levels of estradiol (E2)		one year
The days of coasting	The interval between the day of starting intervention and the day of hCG administration	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
pregnancy rate	one year
number of oocytes retrieved	one year
the incidencess of OHSS	one year

Collaborators and Investigators

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
• Investigators: Study Chair: Jiann-Loung Hwang, MD, Shin-Kong Wu Ho-Su Memerial Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: April 26, 2011
• First Submitted That Met QC Criteria: May 2, 2011
• First Posted (Estimate): May 4, 2011

Study Record Updates

• Last Update Posted (Estimate): May 4, 2011
• Last Update Submitted That Met QC Criteria: May 2, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: IVF; GnRH antagonist; coasting; withdrawing GnRH agonist
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Prolactin Release-Inhibiting Factors
• Other Study ID Numbers: SKH-8302-100-DR-08