Synchronization of Follicle Wave Emergence and Ovarian Stimulation in Women With a History of Poor Ovarian Response to Treatment
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Saskatchewan
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- number of follicles greater than or equal to 15 mm on day of hCG
Study Overview
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. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.
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 Obstetrics, Gynecology and Reproductive Sciences) in Saskatoon, Saskatchewan and the Genesis Fertility Centre in Vancouver, British Columbia will be identified by study physicians and nurses. Patients with a history of poor response to ovarian stimulation therapy in a previous IVF or ICSI cycle, who have already decided to undergo a subsequent treatment cycle, will be contacted by a study physician and offered enrolment into the study. Patients exhibiting all inclusion criteria and no exclusion criteria will be eligible to participate.
Inclusion Criteria:
- 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 Criteria:
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 43 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
1
Initiation of ovarian stimulation therapy on day 1 (i.e., first day of menses)
Intervention: Gonal F (Drug)
1
Initiation of ovarian stimulation therapy on day 1 (i.e., first day of menses)
Intervention: Luveris (Drug)
1
Initiation of ovarian stimulation therapy on day 1 (i.e., first day of menses)
Intervention: Cetrotide (Drug)
1
Initiation of ovarian stimulation therapy on day 1 (i.e., first day of menses)
Intervention: hCG (Drug)
2
Initiation of ovarian stimulation therapy on day 4 (day 1= first day of menses)
Intervention: Gonal F (Drug)
2
Initiation of ovarian stimulation therapy on day 4 (day 1= first day of menses)
Intervention: Luveris (Drug)
2
Initiation of ovarian stimulation therapy on day 4 (day 1= first day of menses)
Intervention: Cetrotide (Drug)
2
Initiation of ovarian stimulation therapy on day 4 (day 1= first day of menses)
Intervention: hCG (Drug)
Outcomes
Primary Outcomes
number of follicles greater than or equal to 15 mm on day of hCG
Time Frame: March 2009
peak serum estradiol concentrations
Time Frame: March 2009
Secondary Outcomes
- number of follicles aspirated(March 2009)
- number of oocytes obtained(March 2009)
- fertilization rates(March 2009)
- blastocyst rate(March 2009)
- clinical pregnancy rate (serum ß-hCG)(March 2009)
- number of antral follicles (day 1 or day 4)(March 2009)
- oocyte morphology(March 2009)
- number of viable embryos (day 3 and day 5)(March 2009)
- number of embryos transferred(March 2009)