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Clinical Trials/NCT01347268
NCT01347268UnknownPhase 4

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

Shin Kong Wu Ho-Su Memorial Hospital1 site in 1 country120 target enrollmentStarted: January 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Enrollment
120
Locations
1
Primary Endpoint
The days of coasting

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 38 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • the risk of ovarian hyperstimulation syndrome

Exclusion Criteria

  • allergic to GnRH antagonist

Arms & Interventions

withdrawing GnRH agonists

Experimental

Intervention: withdrawing GnRH agonists (Procedure)

Outcomes

Primary Outcomes

The days of coasting

Time Frame: one year

The interval between the day of starting intervention and the day of hCG administration

decreased levels of estradiol (E2)

Time Frame: one year

Secondary Outcomes

  • the incidencess of OHSS(one year)
  • pregnancy rate(one year)
  • number of oocytes retrieved(one year)

Investigators

Sponsor Class
Other

Study Sites (1)

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