Back to resultsEndometrial Advancement After Rec or u-HCG Triggering
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
10000 IU urinary HCG
250 mcg recombinant HCG
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring endometrium, histology, pregnancy
Eligibility Criteria
Inclusion Criteria:
- Less than 36 years old
- Male or tubal infertility
- FSH<12 on day 3
Exclusion Criteria:
- Endometriosis stage 3 & 4
Sites / Locations
- Centre for Reproductive Medicine, UZ Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
o Group A=uHCG ovul trig
o Group B=recHCG ovul trig
Arm Description
HCG for triggering
recombinant HCG for triggering
Outcomes
Primary Outcome Measures
endometrium histology on the day of OPU
Secondary Outcome Measures
pregnancy rate
Full Information
NCT ID
NCT00953628
First Posted
August 5, 2009
Last Updated
December 1, 2015
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Merck Serono International SA
1. Study Identification
Unique Protocol Identification Number
NCT00953628
Brief Title
Endometrial Advancement After Rec or u-HCG Triggering
Official Title
Endometrial Advancement After Rec or u-HCG Triggering
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2008 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Merck Serono International SA
4. Oversight
Data Monitoring Committee
No
5. 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.
Detailed Description
Biopsies of endometrium were taken in different groups Pregnancy rates were compared among defferent groups
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
endometrium, histology, pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
o Group A=uHCG ovul trig
Arm Type
Active Comparator
Arm Description
HCG for triggering
Arm Title
o Group B=recHCG ovul trig
Arm Type
Experimental
Arm Description
recombinant HCG for triggering
Intervention Type
Drug
Intervention Name(s)
10000 IU urinary HCG
Other Intervention Name(s)
Pregnyl
Intervention Description
bolus 10000 units for ovulation triggering
Intervention Type
Drug
Intervention Name(s)
250 mcg recombinant HCG
Other Intervention Name(s)
Ovitrelle
Intervention Description
bolus 250 mcg for ovulation triggering in IVF patients
Primary Outcome Measure Information:
Title
endometrium histology on the day of OPU
Time Frame
day of oocytre pick up
Secondary Outcome Measure Information:
Title
pregnancy rate
Time Frame
14 days after oocyte pick up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Less than 36 years old
Male or tubal infertility
FSH<12 on day 3
Exclusion Criteria:
Endometriosis stage 3 & 4
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Devroey, Professor
Organizational Affiliation
Professor or OB-GYN
Official's Role
Study Director
Facility Information:
Facility Name
Centre for Reproductive Medicine, UZ Brussel
City
Brussels
State/Province
Jette
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.brusselsivf.be/taalkeuze.aspx
Description
main web page of the centre for reproductive medicine in UZ Brussels
Learn more about this trial
Endometrial Advancement After Rec or u-HCG Triggering
We'll reach out to this number within 24 hrs