Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: Decapeptyl Daily; Drug: pregnyl

• Registration Number: NCT01607203
• Lead Sponsor: AZ Jan Palfijn Gent

Brief Summary

The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-30
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2013-12-30
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-03
• Last Update Submitted: 2015-02-03
• Results First Posted: 2015-02-19
• Last Update Posted: 2015-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Intra-cytoplasmic sperm injection (ICSI) patients below 38 years
• 1,2 or 3 rd IVF-cycle

Exclusion Criteria

• polycystic ovary syndrome (PCOS) patients
• patients with endocrinological diseases or problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hCG and GnRH agonist	pregnyl	5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC
hCG	pregnyl	5000 IU Pregnyl SC
hCG and GnRH agonist	Decapeptyl Daily	5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC

Primary Outcome Measures

Name	Time	Method
MII Oocytes	3 weeks	the number of mature oocytes retrieved

Secondary Outcome Measures

Name	Time	Method
Pregnancy Rate	12 weeks	the number of pregnancies obtained, wich still is the most important issue for the patients
Patients With Cryopreserved Embryos	4 weeks

Trial Locations

Locations (1)

A Z Jan Palfijn; 🇧🇪 Gent, Oost-vlaanderen, Belgium