Overview

This trial is active, not recruiting.

Condition infertility
Treatment arvekap, pregnyl
Phase phase 4
Sponsor Eugonia
Start date November 2003
End date July 2005
Trial size 60 participants
Trial identifier NCT00415792, arvekap vs pregnyl

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Ongoing pregnancy per embryo transfer
time frame:

Secondary Outcomes

Measure
Biochemical pregnancy per embryo transfer
time frame:
Clinical pregnancy per embryo transfer
time frame:
Embryological data
time frame:

Eligibility Criteria

Female participants from 18 years up to 50 years old.

Inclusion Criteria: - Hyper-responder patients (>20 oocytes retrieved) Exclusion Criteria: - Normal responders - Poor responders - PCOS

Additional Information

Official title Administration of Human Chorionic Gonadotropin (hCG) Versus Gonadotropin Releasing Hormone (GnRH) Agonist for Ovulation Induction in Hyper-Responder Patients
Principal investigator Tryfon Lainas, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2007.
Information provided to ClinicalTrials.gov by Eugonia.