Menopur and Rekovelle combination for personalized ovarian stimulation
Menopur And Rekovelle Combination Study Version 2.0
This test will see if starting Rekovelle and Menopur doses set by a woman's age and weight work as well as doses set by AMH and weight for women aged 18–40 having IVF.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Clinique Ovo Industry-sponsored |
| Locations | 2 sites (Ottawa, Ontario and 1 other locations) |
| Trial ID | NCT06997900 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives women personalized starting doses of follitropin delta (Rekovelle) plus HP‑hMG (Menopur) based on age and body weight during an antagonist IVF protocol. Participants are closely monitored with serial transvaginal ultrasounds and blood tests (including estradiol) through stimulation, followed by standard egg retrieval, fertilization, and embryo assessment. Results will be compared to outcomes reported in the MARCS study to determine whether age/weight dosing produces similar oocyte yield and early embryo development. Safety monitoring includes tracking ovarian hyperstimulation risk and adverse events.
Who should consider this trial
Good fit: Women aged 18–40 having their first IVF/ICSI cycle with regular cycles, both ovaries present, early follicular FSH <10 IU/L, an antagonist protocol prescribed, and infertility due to unexplained, tubal, mild endometriosis (I/II), or male factor are ideal candidates.
Not a fit: Women at high risk of OHSS (AMH ≥35 pmol/L), with endometriosis stage III/IV, those undergoing oocyte donation, BMI >40 kg/m2, significant renal/hepatic impairment, or prior recurrent miscarriages are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the approach could allow clinics that do not routinely use AMH to deliver comparable IVF stimulation results using simpler age-and-weight dosing.
How similar studies have performed: Prior trials such as ESTHER-1 validated AMH-based Rekovelle dosing, MARCS found added benefit when combining Rekovelle with Menopur, and RITA-1/2 provided preliminary support for age/weight dosing, so this approach builds on existing promising data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 18 to 40 years inclusively at the time of consent form signature * Diagnosis of unexplained infertility, tubal infertility, endometriosis stage I/II or 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 and Day 5 of menstrual cycle within the previous 24 months * First IVF/ICSI cycle * IVF antagonist protocol prescribed * Partner or donor ejaculated sperm (fresh or frozen) used for fertilization Exclusion Criteria: * Women undergoing oocyte donation * Endometriosis stage III/IV * High risk of OHSS (AMH ≥ 35 pmol/L) * Body Mass Index (BMI) \> 40 kg/m2 Protocol number: IIS-1056 MARCS 2.0 Study Version: 1.1 - Date : 14 APR 2025 Page 12 of 28 * Gynaecological haemorrhages of unknown aetiology * History of recurrent miscarriages defined as ≥ 3 consecutive losses * Renal or hepatic impairment * Hypersensitivity to any active ingredient or excipients in follitropin delta and/or HP-hMG * Tumours of hypothalamus or pituitary gland * Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome * Current or history of ovarian, uterine or mammary carcinoma * History of thrombophilia * Use of hormonal preparations (except for 17β-estradiol, testosterone gel, DHEA and thyroid medication) during the last menstrual cycle * Women participating in any other interventional research project
Where this trial is running
Ottawa, Ontario and 1 other locations
- Ottawa fertility centre — Ottawa, Ontario, Canada (Recruiting)
- Clinique ovo — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Marya Far
- Email: m.far@cliniqueovo.com
- Phone: 514-798-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.