Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium

NCT00976651 | Completed Phase 4

• 1 other identifier: CBLD2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

infertility; ICSI; hCG; infertility treatment

Outcome Measures

Primary Outcomes (1)

• number of oocytes

  2 weeks after start of the treatment

Study Arms (2)

Recombinant FSH

ACTIVE COMPARATOR

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.

Drug: human menopausal gonadotropin

human chorionic gonadotropin

EXPERIMENTAL

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

Drug: human menopausal gonadotropin

Interventions

human menopausal gonadotropin DRUG

200 IU per day in the late follicular phase

Recombinant FSH; human chorionic gonadotropin

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \< 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Laarbeeklaan 101, Brussels Capital, 1090, Belgium

Location

Related Publications (1)

• 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.

  PMID: 19617207 RESULT

MeSH Terms

Conditions

Infertility

Interventions

Menotropins

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 25, 2010

Record last verified: 2009-09

Locations

BE (1)