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Endometrial Advancement After Rec or u-HCG Triggering

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.
ClinicalTrials.gov Identifier: NCT00953628
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : December 3, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Infertility 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  (Clinical Trial)
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 : August 2005
Primary Completion Date : December 2006
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: August 6, 2009    Key Record Dates
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