Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium

NCT ID: NCT00976651

Last Updated: 2010-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-12-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Recombinant FSH

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.

Group Type: ACTIVE_COMPARATOR

human menopausal gonadotropin

Intervention Type: DRUG

200 IU per day in the late follicular phase

human chorionic 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

Group Type: EXPERIMENTAL

human menopausal gonadotropin

Intervention Type: DRUG

200 IU per day in the late follicular phase

Interventions

human menopausal gonadotropin

200 IU per day in the late follicular phase

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Universitair Ziekenhuis Brussel

Locations

UZ Brussel

Laarbeeklaan 101, Brussels Capital, Belgium

Countries

Belgium

References

Blockeel C, De Vos M, Verpoest W, Stoop D, Haentjens P, Devroey P. Can 200 IU of hCG replace recombinant FSH in the late follicular phase in a GnRH-antagonist cycle? A pilot study. Hum Reprod. 2009 Nov;24(11):2910-6. doi: 10.1093/humrep/dep253. Epub 2009 Jul 17.

Reference Type: RESULT

PMID: 19617207 (View on PubMed)

Other Identifiers

CBLD2

Identifier Type: -

Identifier Source: org_study_id