Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 11, 2009
March 24, 2010
January 2009
November 2009   (final data collection date for primary outcome measure)
number of oocytes [ Time Frame: 2 weeks after start of the treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00976651 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Infertility
Drug: human menopausal gonadotropin
200 IU per day in the late follicular phase
  • 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.
    Intervention: Drug: human menopausal gonadotropin
  • 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

    Intervention: Drug: human menopausal gonadotropin
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 Jul 17; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2009
November 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 36 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00976651
CBLD2
No
Paul Devroey, Universitair Ziekenhuis Brussel
Universitair Ziekenhuis Brussel
Not Provided
Not Provided
Universitair Ziekenhuis Brussel
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP