Comparison Between hCG and GnRH Agonist for Ovulation Induction in Patients With High Response to IVF Drugs

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2007 by Eugonia.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Eugonia

ClinicalTrials.gov Identifier:

NCT00415792

First received: December 22, 2006

Last updated: January 4, 2007

Last verified: January 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

December 22, 2006

Last Updated Date

January 4, 2007

Start Date ^ICMJE

November 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Ongoing pregnancy per embryo transfer

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00415792 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Biochemical pregnancy per embryo transfer
Clinical pregnancy per embryo transfer
Embryological data

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison Between hCG and GnRH Agonist for Ovulation Induction in Patients With High Response to IVF Drugs

Official Title ^ICMJE

Administration of Human Chorionic Gonadotropin (hCG) Versus Gonadotropin Releasing Hormone (GnRH) Agonist for Ovulation Induction in Hyper-Responder Patients

Brief Summary

hCG and GnRH agonist can be used to induce final oocyte maturation and ovulation in IVF cycles. These two approaches will be compared in this study in terms of pregnancy rates and embryological data using patients with hyper-response to IVF drugs.

Detailed Description

hCG is commonly used for the substitution of the endogenous LH surge to induce oocyte maturation and ovulation induction in ovarian hyperstimulation protocols for in vitro fertilization (IVF). However, hCG is related to the occurrence of the ovarian hyperstimulation syndrome (OHSS), a potentially life-threatening complication and hyper-responding patients are particularly in high risk. An alternative to exogenous hCG is the administration of a GnRH agonist inducing an endogenous rise in both LH and FSH levels due to the initial flare effect.

Comparisons: Pregnancy rates and embryological data will be compared from hyper-responding patients receiving either GnRH agonist (Arvekap) or hCG (Pregnyl) for ovulatrion induction following a GnRH antagonist treatment cycle.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Infertility

Intervention ^ICMJE

Drug: Arvekap, Pregnyl

Study Arm (s)

Not Provided

Publications *

Griesinger G, Diedrich K, Devroey P, Kolibianakis EM. GnRH agonist for triggering final oocyte maturation in the GnRH antagonist ovarian hyperstimulation protocol: a systematic review and meta-analysis. Hum Reprod Update. 2006 Mar-Apr;12(2):159-68. Epub 2005 Oct 27. Review.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

July 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Hyper-responder patients (>20 oocytes retrieved)

Exclusion Criteria:

Normal responders
Poor responders
PCOS

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Greece

Administrative Information

NCT Number ^ICMJE

NCT00415792

Other Study ID Numbers ^ICMJE

arvekap vs pregnyl

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eugonia

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Tryfon Lainas, PhD

Eugonia

Information Provided By

Eugonia

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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