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

This study is ongoing, but not recruiting participants.

Sponsored by: Eugonia
Information provided by: Eugonia
ClinicalTrials.gov Identifier: NCT00415792
  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 IV

MedlinePlus related topics:   Infertility   

ChemIDplus related topics:   Chorionic gonadotropin    Choriogonadotropin Alfa    Gonadorelin    Gonadorelin hydrochloride    LH-RH   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Administration of Human Chorionic Gonadotropin (hCG) Versus Gonadotropin Releasing Hormone (GnRH) Agonist for Ovulation Induction in Hyper-Responder Patients

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

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:

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

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

Study placed in the following topic categories:
Genital Diseases, Female
Deslorelin
Infertility
Hyperkinesis
Chorionic Gonadotropin
Genital Diseases, Male

Additional relevant MeSH terms:
Therapeutic Uses
Physiological Effects of Drugs
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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