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| Sponsors and Collaborators: |
University of Saskatchewan Royal University Hospital Foundation |
| Information provided by: | University of Saskatchewan |
| ClinicalTrials.gov Identifier: | NCT00439829 |
Purpose
The objective of the study is to elucidate the effect of synchronizing initiation of ovarian stimulation treatment with follicular wave emergence in poor responder patients undergoing IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.
| Condition | Intervention | Phase |
|
Infertility |
Drug: Gonal F Drug: Luveris Drug: Cetrotide Drug: hCG |
Phase IV |
| MedlinePlus related topics: | Infertility |
| ChemIDplus related topics: | Follitropin beta Urofollitropin Choriogonadotropin Alfa Chorionic gonadotropin Cetrorelix Cetrorelix acetate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Synchronization of Follicle Wave Emergence and Ovarian Stimulation in Women With a History of Poor Ovarian Response to Treatment |
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Initiation of ovarian stimulation therapy on day 1 (i.e., first day of menses)
|
Drug: Gonal F
- 10,000 IU hCG (Pharmaceutical Partners of Canada Inc.) subcutaneously when: o > 3 follicles are > 17 mm in diameter |
|
2: Active Comparator
Initiation of ovarian stimulation therapy on day 4 (day 1= first day of menses)
|
Drug: Gonal F
- 10,000 IU hCG (Pharmaceutical Partners of Canada Inc.) subcutaneously when: o > 3 follicles are > 17 mm in diameter |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 43 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
History of poor response to ovarian stimulation as determined by:
Exclusion Criteria:
Contacts and Locations| Contact: Angela R Baerwald, PhD | 306-966-8073 | angela.baerwald@usask.ca |
| Canada, British Columbia | |||||
| Genesis Fertility Centre | Recruiting | ||||
| Vancouver, British Columbia, Canada, V5Z 3X7 | |||||
| Contact: Margo Fluker, MD FRCSC 1-800-753-0111 fluker@genesis-fertility.com | |||||
| Contact: Stephanie Fisher, MD FRCSC 1-800-753-0111 fisher@genesis-fertility.com | |||||
| Sub-Investigator: Margo Fluker, MD FRCSC | |||||
| Sub-Investigator: Stephanie Fisher, MD FRCSC | |||||
| Canada, Saskatchewan | |||||
| Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan | Recruiting | ||||
| Saskatoon, Saskatchewan, Canada, S7N0W8 | |||||
| Sub-Investigator: Angela R Baerwald, PhD CCRP | |||||
| Principal Investigator: Allison M Case, MD FRCSC | |||||
| University of Saskatchewan |
| Royal University Hospital Foundation |
| Study Director: | Angela R Baerwald, PhD | Dept OB/GYN, University of Saskatchewan |
| Principal Investigator: | Allison M Case, MD FRCSC | Dept OB/GYN, University of Saskatchewan |
More Information
| Responsible Party: | Reproductive Biology Research Unit, Dept OB/GYN, University of Saskatchewan ( Angela Baerwald - Scientific Investigator ) |
| Study ID Numbers: | BIO-REB 06-03, HlthCanadaFile#9427-U0208-47C |
| First Received: | February 13, 2007 |
| Last Updated: | May 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00439829 |
| Health Authority: | Canada: Health Canada |
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