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Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Shin Kong Wu Ho-Su Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01347268
First received: April 26, 2011
Last updated: May 2, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
In Vitro Fertilization
Procedure: GnRH antagonist
Procedure: withdrawing GnRH agonists
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist Administration in Patients at Risk for Severe OHSS

Resource links provided by NLM:


Further study details as provided by Shin Kong Wu Ho-Su Memorial Hospital:

Primary Outcome Measures:
  • decreased levels of estradiol (E2) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • The days of coasting [ Time Frame: one year ] [ Designated as safety issue: No ]
    The interval between the day of starting intervention and the day of hCG administration


Secondary Outcome Measures:
  • number of oocytes retrieved [ Time Frame: one year ] [ Designated as safety issue: No ]
  • pregnancy rate [ Time Frame: one year ] [ Designated as safety issue: No ]
  • the incidencess of OHSS [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • the risk of ovarian hyperstimulation syndrome

Exclusion Criteria:

  • allergic to GnRH antagonist
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347268

Contacts
Contact: Jiann-Loung Hwang, MD 886-2-28332211 ext 3879 m001015@ms.skh.org.tw
Contact: Heng-Ju Chen, MD 886-2-28332211 ext 3870 m004983@ms.skh.org.tw

Locations
Taiwan
Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memerial Hospital Recruiting
Taipei, Taiwan
Contact: Jiann-Loung Hwang, MD    886-2-28332211 ext 3879    m001015@ms.skh.org.tw   
Contact: Heng-Ju Chen, MD    886-2-28332211 ext 3870    m004983@ms.skh.orh.tw   
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Investigators
Study Chair: Jiann-Loung Hwang, MD Shin-Kong Wu Ho-Su Memerial Hospital
  More Information

No publications provided

Responsible Party: Jiann-Loung Hwang, Shin-Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT01347268     History of Changes
Other Study ID Numbers: SKH-8302-100-DR-08
Study First Received: April 26, 2011
Last Updated: May 2, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
coasting
withdrawing GnRH agonist
GnRH antagonist
IVF

Additional relevant MeSH terms:
Deslorelin
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Enzyme Inhibitors
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014