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

• Sponsor: Eugonia (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00415792
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 20
• Patients Per Site Per Month: 3

Study Details

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.

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 Design

• Study Type: Interventional
• 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: Nov 1, 2003
• Study Completion Date: Jul 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Hyper-responder patients (>20 oocytes retrieved)

Exclusion Criteria:

• Normal responders

• Poor responders

• PCOS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eugonia	Athens		Greece	11528

Sponsors and Collaborators

• Eugonia

Investigators

• Principal Investigator: Tryfon Lainas, PhD, Eugonia

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Epub 2005 Oct 27.

• ClinicalTrials.gov Identifier: NCT00415792
• Other Study ID Numbers: arvekap vs pregnyl
• First Posted: Dec 25, 2006
• Last Update Posted: Jan 5, 2007
• Last Verified: Jan 1, 2007

• Keywords provided by , ,: Ovulation induction; hCG; GnRH agonist; hyper-responders
• Additional relevant MeSH terms: Infertility; Chorionic Gonadotropin

Study Results

No Results Posted as of Jan 5, 2007