Status:
COMPLETED
Synchronization of Follicle Wave Emergence and Ovarian Stimulation
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Royal University Hospital Foundation
Conditions:
Infertility
Eligibility:
FEMALE
18-43 years
Phase:
PHASE4
Brief Summary
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....
Detailed Description
Sample Population Eligible patients undergoing IVF or ICSI for the treatment of infertility in the Assisted Reproductive Technologies Center at the University of Saskatchewan (ARTUS; Department of Obs...
Eligibility Criteria
Inclusion
- Informed consent obtained
- Age of 43 years or younger
- 18 \< BMI \< 35
- History of poor response to ovarian stimulation as determined by:
- previously cancelled oocyte retrieval procedure due to \< 4 follicles greater than 12 mm on ultrasound OR
- \< 3 mature oocytes
- Physical exam performed within the past 12 months
- Normal or corrected levels of TSH and Prolactin within the past 12 months
- Has not taken ovarian suppression therapy within 1 month of initiating study drug
Exclusion
- Chronic medical conditions such as renal failure
- Documented ovarian failure
- Presence of only one ovary
- Serum Day 3 FSH \> 12 IU/L within the past 6 months
- Ovaries inaccessible transvaginally
- Concomitant glucocorticoid use
- Ongoing pregnancy
- Any contraindications to ovarian stimulation treatment
- Participation in an investigational drug trial in the 30 days prior to the pre-study visit
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00439829
Start Date
February 1 2007
End Date
May 1 2010
Last Update
May 25 2010
Active Locations (2)
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1
Genesis Fertility Centre
Vancouver, British Columbia, Canada, V5Z 3X7
2
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N0W8