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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415792
Recruitment Status : Unknown
Verified January 2007 by Eugonia.
Recruitment status was:  Active, not recruiting
First Posted : December 25, 2006
Last Update Posted : January 5, 2007
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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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Arvekap, Pregnyl Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Administration of Human Chorionic Gonadotropin (hCG) Versus Gonadotropin Releasing Hormone (GnRH) Agonist for Ovulation Induction in Hyper-Responder Patients
Study Start Date : November 2003
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Ongoing pregnancy per embryo transfer

Secondary Outcome Measures :
  1. Biochemical pregnancy per embryo transfer
  2. Clinical pregnancy per embryo transfer
  3. Embryological data

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Hyper-responder patients (>20 oocytes retrieved)

Exclusion Criteria:

  • Normal responders
  • Poor responders
  • PCOS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00415792

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Athens, Greece, 11528
Sponsors and Collaborators
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Principal Investigator: Tryfon Lainas, PhD Eugonia

Layout table for additonal information Identifier: NCT00415792     History of Changes
Other Study ID Numbers: arvekap vs pregnyl
First Posted: December 25, 2006    Key Record Dates
Last Update Posted: January 5, 2007
Last Verified: January 2007
Keywords provided by Eugonia:
Ovulation induction
GnRH agonist
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reproductive Control Agents
Physiological Effects of Drugs