Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium

This study has been completed.
Sponsor:
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00976651
First received: September 11, 2009
Last updated: March 24, 2010
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: human menopausal gonadotropin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Influence of Ovarian Stimulation With 200 IU of hCG, (Administered in the Late Follicular Phase Among ICSI Patients Undergoing a GnRH-antagonist Protocol), on the Endometrium on the Day of Oocyte Pick-up

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • number of oocytes [ Time Frame: 2 weeks after start of the treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: human menopausal gonadotropin
200 IU per day in the late follicular phase
Experimental: 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

Drug: human menopausal gonadotropin
200 IU per day in the late follicular phase

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00976651

Locations
Belgium
UZ Brussel
Laarbeeklaan 101, Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
  More Information

Publications:
Responsible Party: Paul Devroey, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00976651     History of Changes
Other Study ID Numbers: CBLD2
Study First Received: September 11, 2009
Last Updated: March 24, 2010
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitair Ziekenhuis Brussel:
infertility
ICSI
hCG
infertility treatment

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Chorionic Gonadotropin
Menotropins
Fertility Agents
Fertility Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014