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Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)

This study has been terminated.
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01109888
First received: April 22, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

Coasting is one of the means to reduce the risk of OHSS for patients at risk for severe OHSS. During coasting gonadotrophin administration is withheld until serum E2 levels drop to a range considered safe. Prolonged coasting reduces the chance for implantation and pregnancy. The aim of the study is to explore whether an increased dose of GnRH Antagonist will shorten the coasting period without an adverse effect on cycle outcome.


Condition Intervention Phase
Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)
 Drug: Cetrotide
 Phase 1
Phase 2

Study Type: Interventional
Official Title: Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian During Controlled Ovarian Stimulation(COH) for In Vitro Fertilisation(IVF)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wolfson Medical Center:

Arms Assigned Interventions
Active Comparator: Cetrotide Drug: Cetrotide

Detailed Description:

30 patients undergoing IVF using a GnRH antagonist protocol that present with a high response to gonadotrophin stimulation, will be randomized into one of two groups: group A - withdrawal of gonadotrophin support and continue a daily dose of 0.25 mg of the GnRH antagonist. group B - withdrawal of gonadotrophin support and continue a double daily dose of 0.5 mg of the GnRH antagonist.

The main outcome measures will be the duration of coasting (days)and the rate of serum E2 drop (%).

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:30 women undergoing IVF cycle with GnRH Antagonist protocol under 35 years old.

E2 higher than 3000 pg/ml. -

Exclusion Criteria: 3 or more failed fresh IVF cycles.

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  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Levran D., M.D, IVF Unit, Wolfson Medical center
ClinicalTrials.gov Identifier: NCT01109888     History of Changes
Other Study ID Numbers: 12101967
Study First Received: April 22, 2010
Last Updated: April 22, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
 Cetrorelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013