Status:
COMPLETED
Menopur And Rekovelle Combination Study
Lead Sponsor:
Dr François Bissonnette
Collaborating Sponsors:
Create Fertility Center
Olive Fertility Centre
Conditions:
Fertility Disorders
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in a "mixed protocol" regimen, using an individualized, fixed dose of follitropin delta based on the establis...
Detailed Description
The initial dose of follitropin delta will be determined at enrolment by the analysis of serum AMH on days 2 to 5 of the menstrual cycle preceding the IVF treatment cycle and body weight in Kg The ini...
Eligibility Criteria
Inclusion
- Women 18 to 40 years of age undergoing their first IVF/ICSI cycle
- Diagnosed with unexplained infertility, tubal infertility, endometriosis stage I/II, or with partners diagnosed with male factor infertility
- Regular menstrual cycles of 24-35 days
- Presence of both ovaries
- Early follicular phase FSH serum concentration \<10 IU/L measured between Day 2 to Day 5 of menstrual cycle within the previous 12 months
- Ejaculated sperm (fresh or frozen) for insemination
Exclusion
- Inability to consent
- Endometriosis stage III and IV
- High risk of OHSS (AMH ≥ 35 pmol/L)
- History of recurrent miscarriages defined as ≥ 3 consecutive losses
- Women undergoing egg donation
- Women participating in any other research project
- Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle
- Hypersensitivity to follitropin delta and/or HP-hMG
Key Trial Info
Start Date :
July 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03483545
Start Date
July 17 2018
End Date
July 31 2019
Last Update
August 28 2019
Active Locations (4)
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1
Olive Fertility Centre
Vancouver, British Columbia, Canada, V5Z 3X7
2
Hannam Fertility Centre
Toronto, Ontario, Canada, M4W 3R2
3
CReATe Fertility Centre
Toronto, Ontario, Canada, M5G 1N8
4
Clinique Ovo
Montreal, Quebec, Canada, H4P 2S4