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Sponsored by: |
Universitair Ziekenhuis Brussel |
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Information provided by: | Universitair Ziekenhuis Brussel |
ClinicalTrials.gov Identifier: | NCT00750100 |
In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.
Condition | Intervention | Phase |
---|---|---|
Infertility |
Drug: human chorionic gonadotropin Drug: recombinant gonadotropins |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Among ICSI Patients Undergoing Antagonist Protocols With Recombinant FSH, Does Replacement of Recombinant FSH by 200 IU of hCG in the Late Follicular Phase Compared With Continuing Recombinant FSH, Result in a Similar Number of Oocytes? |
Enrollment: | 70 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | November 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.
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Drug: recombinant gonadotropins
200 IU per day during controlled ovarian stimulation
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B: Experimental
Patients are undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins.
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Drug: human chorionic gonadotropin
hCG 200IU in the late follicular phase
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Ages Eligible for Study: | 18 Years to 36 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium, Brussels | |
UZ Brussel | |
Laarbeeklaan 101, Brussels, Belgium, 1090 |
Principal Investigator: | Christophe Blockeel, MD | UZ Brussel, Centre for Reproductive Medicine, Brussels |
Responsible Party: | Universitair Ziekenhuis Brussel ( Paul Devroey ) |
Study ID Numbers: | EC REF 2006-157 |
Study First Received: | September 9, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00750100 History of Changes |
Health Authority: | Belgium: Ethics Committee |
infertility IVF hCG |
primary infertility secondary infertility patients requiring in-vitro fertilisation |
Genital Diseases, Female Infertility Neoplasm Metastasis Chorionic Gonadotropin Genital Diseases, Male |
Genital Diseases, Female Infertility Therapeutic Uses Physiological Effects of Drugs |
Reproductive Control Agents Chorionic Gonadotropin Genital Diseases, Male Pharmacologic Actions |