Clincosm LogoSign in Get a demo

Endometrial Advancement After Rec or u-HCG Triggering

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Completed
CT.gov ID
NCT00953628
Collaborator
Merck Serono International SA (Industry)
130
Enrollment
1
Location
2
Arms
40
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate any potential advantages of replacing human chorionic gonadotropin (uhCG) with recombinant human chorionic gonadotropin (recHCG) for final oocyte maturation with regard to Ovarian hyperstimulation syndrome (OHSS)pathophysiology, endometrium receptivity and embryo quality and clinical pregnancy.

Condition or Disease Intervention/Treatment Phase
  • Drug: 10000 IU urinary HCG
  • Drug: 250 mcg recombinant HCG
 Phase 4

Detailed Description

Biopsies of endometrium were taken in different groups Pregnancy rates were compared among defferent groups

Study Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Endometrial Advancement After Rec or u-HCG Triggering
Study Start Date :
Aug 1, 2005
Actual Primary Completion Date :
Dec 1, 2006
Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: o Group A=uHCG ovul trig

HCG for triggering

Drug: 10000 IU urinary HCG
bolus 10000 units for ovulation triggering
Other Names:
  • Pregnyl

    		•
    Experimental: o Group B=recHCG ovul trig

    recombinant HCG for triggering

    Drug: 250 mcg recombinant HCG
    bolus 250 mcg for ovulation triggering in IVF patients
    Other Names:
  • Ovitrelle

    		•

    Outcome Measures

    Primary Outcome Measures

    1. endometrium histology on the day of OPU [day of oocytre pick up]

    Secondary Outcome Measures

    1. pregnancy rate [14 days after oocyte pick up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 36 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Less than 36 years old

    • Male or tubal infertility

    • FSH<12 on day 3

    Exclusion Criteria:
    • Endometriosis stage 3 & 4

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Reproductive Medicine, UZ Brussel Brussels Jette Belgium 1090

    Sponsors and Collaborators

    • Universitair Ziekenhuis Brussel
    • Merck Serono International SA

    Investigators

    • Study Director: Paul Devroey, Professor, Professor or OB-GYN

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Papanikolaou Evangelos, Lecturer Aristotle University Greece, Universitair Ziekenhuis Brussel
    ClinicalTrials.gov Identifier:
    NCT00953628
    Other Study ID Numbers:
    • recHCG001
    First Posted:
    Aug 6, 2009
    Last Update Posted:
    Dec 3, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Papanikolaou Evangelos, Lecturer Aristotle University Greece, Universitair Ziekenhuis Brussel
    endometrium
    histology
    pregnancy
    Additional relevant MeSH terms:
    Infertility
    Chorionic Gonadotropin

    Study Results

    No Results Posted as of Dec 3, 2015