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NCT00953628 Clinical Trial

Endometrial Advancement After Rec or u-HCG Triggering

Infertility Clinical Trial

Official title:
Endometrial Advancement After Rec or u-HCG Triggering

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00953628
Other study ID # recHCG001
Secondary ID
Status Completed
Phase Phase 4
First received August 5, 2009
Last updated December 1, 2015
Start date August 2005
Est. completion date December 2008

Study information
Verified date December 2015
Source Universitair Ziekenhuis Brussel
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date December 2008
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 36 Years
Eligibility Inclusion Criteria:

- Less than 36 years old

- Male or tubal infertility

- FSH<12 on day 3

Exclusion Criteria:

- Endometriosis stage 3 & 4

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 10000 IU urinary HCG
bolus 10000 units for ovulation triggering
• 250 mcg recombinant HCG
bolus 250 mcg for ovulation triggering in IVF patients

Locations
Country Name City State
Belgium Centre for Reproductive Medicine, UZ Brussel Brussels Jette

Sponsors (2)
Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel Merck Serono International SA

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary endometrium histology on the day of OPU day of oocytre pick up No
Secondary pregnancy rate 14 days after oocyte pick up No
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