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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Eugonia

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.


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


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

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 ClinicalTrials.gov identifier (NCT number): NCT00415792


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

Publications:
ClinicalTrials.gov 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
hCG
GnRH agonist
hyper-responders

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Deslorelin
Chorionic Gonadotropin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reproductive Control Agents
Physiological Effects of Drugs