Fertility Disorders
Conditions
Keywords
Ovarian Response, In vitro fertilization, Controlled ovarian stimulation
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 established algorithm, combined with a variable, adjustable dose of Menopur based on body weight and ovarian reserve.
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 initial dose of HP-hMG to be added on top of follitropin delta will be determined at enrolment by the total follitropin delta dose and body weight in Kg
Interventions
COMBINATION_PRODUCTFollitropin delta and HP-hMG
Follitropin delta dose will be determined by AMG and weight in Kg. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight in Kg
Sponsors
Create Fertility Center
Olive Fertility Centre
Hannam Fertility Centre
Dr François Bissonnette
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture | 6 days of embryo culture | Utilizable blastocyst is defined as embryo at day 5 or 6 suitable for transfer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine dosage of REKOVELLE and Menopur in a mixed protocol | up to 20 days | Evaluate the effect of adding HP-hMG (Menopur) to follitropin delta (REKOVELLE) during IVF stimulation |
| Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm | up to 20 days | 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. |
Countries
Canada
Outcome results
None listed