Fertility Disorders Clinical Trial
— MARCSOfficial title:
An Exploratory Study to Evaluate a Mixed Protocol of Menopur (Highly Purified Human Menopausal Gonadotropin) and REKOVELLE (Follitropin Delta) for Controlled Ovarian Stimulation in IVF (in Vitro Fertilization)
NCT number | NCT03483545 |
Other study ID # | 000324 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 17, 2018 |
Est. completion date | July 31, 2019 |
Verified date | August 2019 |
Source | OVO R & D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 established algorithm, combined with a variable, adjustable dose of Menopur based on body weight and ovarian reserve.
Status | Completed |
Enrollment | 160 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Clinique Ovo | Montreal | Quebec |
Canada | CReATe Fertility Centre | Toronto | Ontario |
Canada | Hannam Fertility Centre | Toronto | Ontario |
Canada | Olive Fertility Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Dr François Bissonnette | Create Fertility Center, Hannam Fertility Centre, Olive Fertility Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture | Utilizable blastocyst is defined as embryo at day 5 or 6 suitable for transfer | 6 days of embryo culture | |
Secondary | Determine dosage of REKOVELLE and Menopur in a mixed protocol | Evaluate the effect of adding HP-hMG (Menopur) to follitropin delta (REKOVELLE) during IVF stimulation | up to 20 days | |
Secondary | Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm | The safety profile is the proportion of women with early and late OHSS and/or preventive interventions for early OHSS (i.e., triggering with GnRH agonist, use of dopamine agonist, conversion of planned fresh transfer into a freeze-all). OHSS is defined as an iatrogenic complication that occurs mainly due to ovarian overstimulation by gonadotropins. | up to 20 days |
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