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

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Arvekap, Pregnyl
Sponsored by
Eugonia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Ovulation induction, hCG, GnRH agonist, hyper-responders

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Hyper-responder patients (>20 oocytes retrieved)

Exclusion Criteria:

  • Normal responders
  • Poor responders
  • PCOS

Sites / Locations

  • Eugonia

Outcomes

Primary Outcome Measures

Ongoing pregnancy per embryo transfer

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2006
Last Updated
January 4, 2007
Sponsor
Eugonia
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1. Study Identification

Unique Protocol Identification Number
NCT00415792
Brief Title
Comparison Between hCG and GnRH Agonist for Ovulation Induction in Patients With High Response to IVF Drugs
Official Title
Administration of Human Chorionic Gonadotropin (hCG) Versus Gonadotropin Releasing Hormone (GnRH) Agonist for Ovulation Induction in Hyper-Responder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eugonia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Ovulation induction, hCG, GnRH agonist, hyper-responders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Arvekap, Pregnyl
Primary Outcome Measure Information:
Title
Ongoing pregnancy per embryo transfer
Secondary Outcome Measure Information:
Title
Biochemical pregnancy per embryo transfer
Title
Clinical pregnancy per embryo transfer
Title
Embryological data

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hyper-responder patients (>20 oocytes retrieved) Exclusion Criteria: Normal responders Poor responders PCOS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tryfon Lainas, PhD
Organizational Affiliation
Eugonia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eugonia
City
Athens
ZIP/Postal Code
11528
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
16254001
Citation
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. doi: 10.1093/humupd/dmi045. Epub 2005 Oct 27.
Results Reference
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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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