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
  Purpose

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 Intervention Phase
Infertility
Drug: Arvekap, Pregnyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eugonia:

Primary Outcome Measures:
  • Ongoing pregnancy per embryo transfer

Secondary Outcome Measures:
  • Biochemical pregnancy per embryo transfer
  • Clinical pregnancy per embryo transfer
  • Embryological data

Estimated Enrollment: 60
Study Start Date: November 2003
Estimated Study Completion Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hyper-responder patients (>20 oocytes retrieved)

Exclusion Criteria:

  • Normal responders
  • Poor responders
  • PCOS
  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: NCT00415792

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

Publications:
ClinicalTrials.gov Identifier: NCT00415792     History of Changes
Other Study ID Numbers: arvekap vs pregnyl
Study First Received: December 22, 2006
Last Updated: January 4, 2007
Health Authority: Greece: National Organization of Medicines

Keywords provided by Eugonia:
Ovulation induction
hCG
GnRH agonist
hyper-responders

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

ClinicalTrials.gov processed this record on August 19, 2014