Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium

Universitair Ziekenhuis Brussel

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: human menopausal gonadotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT00976651

CBLD2

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Recombinant FSH

Active Comparator group

Description:

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.

Treatment:

Drug: human menopausal gonadotropin

human chorionic gonadotropin

Experimental group

Description:

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

Treatment:

Drug: human menopausal gonadotropin