We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endometrial Advancement After Rec or u-HCG Triggering

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953628
First Posted: August 6, 2009
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
Papanikolaou Evangelos, Universitair Ziekenhuis Brussel
  Purpose
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 Intervention Phase
Infertility Drug: 10000 IU urinary HCG Drug: 250 mcg recombinant HCG Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Endometrial Advancement After Rec or u-HCG Triggering

Resource links provided by NLM:


Further study details as provided by Papanikolaou Evangelos, Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • endometrium histology on the day of OPU [ Time Frame: day of oocytre pick up ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: 14 days after oocyte pick up ]

Enrollment: 130
Study Start Date: August 2005
Estimated Study Completion Date: December 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: o Group A=uHCG ovul trig
HCG for triggering
Drug: 10000 IU urinary HCG
bolus 10000 units for ovulation triggering
Other Name: 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 Name: Ovitrelle

Detailed Description:
Biopsies of endometrium were taken in different groups Pregnancy rates were compared among defferent groups
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953628


Locations
Belgium
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
  More Information

Additional Information:
Responsible Party: Papanikolaou Evangelos, Lecturer Aristotle University Greece, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00953628     History of Changes
Other Study ID Numbers: recHCG001
First Submitted: August 5, 2009
First Posted: August 6, 2009
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Papanikolaou Evangelos, Universitair Ziekenhuis Brussel:
endometrium
histology
pregnancy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female