Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist

NCT ID: NCT01347268

Last Updated: 2011-05-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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In Vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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withdrawing GnRH agonists

Group Type EXPERIMENTAL

withdrawing GnRH agonists

Intervention Type PROCEDURE

withdrawing GnRH agonists and continued low dose r-FSH 75 IU

GnRH antagonist administration

Group Type EXPERIMENTAL

GnRH antagonist

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

withdrawing GnRH agonists

withdrawing GnRH agonists and continued low dose r-FSH 75 IU

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* the risk of ovarian hyperstimulation syndrome

Exclusion Criteria

* allergic to GnRH antagonist
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jiann-Loung Hwang, MD

Role: CONTACT

886-2-28332211 ext. 3879

Heng-Ju Chen, MD

Role: CONTACT

886-2-28332211 ext. 3870

Facility Contacts

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Jiann-Loung Hwang, MD

Role: primary

886-2-28332211 ext. 3879

Heng-Ju Chen, MD

Role: backup

886-2-28332211 ext. 3870

Other Identifiers

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SKH-8302-100-DR-08

Identifier Type: -

Identifier Source: org_study_id

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