Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: human menopausal gonadotropin

• Registration Number: NCT00976651
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

The purpose of the present study is to assess the influence of the administration of low dose hCG on the endometrium. The study is a randomised trial where 2 groups of patients, undergoing a gonadotropin-releasing hormone antagonist protocol for in vitro fertilization, are studied. In addition to the histological findings, by analysing the correlation of the morphological pattern and gene expression profile of human endometrium on the day of oocyte retrieval in patients of both treatment groups, the investigators want to study the implantation potential.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-09
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Last Update Submitted: 2010-03-24
• Last Update Posted: 2010-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• < 36 years on day of randomisation
• FSH < 12 in the early follicular phase
• Normal ultrasound scan
• BMI between 18 and 29 (both inclusive)
• Randomisation at outpatient clinic

Exclusion Criteria

• Endometriosis ≥ grade 3
• PCO syndrome
• Poor responder
• Endocrine or metabolic abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant FSH	human menopausal gonadotropin	Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins. Histology and gene expression is studied on the endometrium.
human chorionic gonadotropin	human menopausal gonadotropin	Patients undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins. Histology and gene expression is studied on the endometrium

Primary Outcome Measures

Name	Time	Method
number of oocytes	2 weeks after start of the treatment

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Laarbeeklaan 101, Brussels, Belgium