NCT06997900 Menopur And Rekovelle Combination Study Version 2.0
| NCT ID | NCT06997900 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Clinique Ovo |
| Condition | IVF |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-07-04 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-07-04 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the safety and effectiveness of a personalized ovarian stimulation regimen in women aged 18 to 40 undergoing in vitro fertilization (IVF). The main question it aims to answer is: \- Does personalizing the starting doses of follitropin delta (REKOVELLE) and HP-hMG (MENOPUR) based on both age and body lead to similar results as anti-Müllerian hormone (AMH) and weight based dosing ? Researchers will compare the new dosing regimen to the MARCS study results to see if this new approach leads to similar outcomes Participants will: * Receive ovarian stimulation using a personalized dose of REKOVELLE aND MENOPUR based on age and weight * Be monitored through ultrasound imaging and blood tests to measure estradiol (E2) levels * Undergo standard IVF procedures including egg retrieval and embryo assessment
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06997900 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying IVF. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06997900 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06997900 currently recruiting?
Yes, NCT06997900 is actively recruiting participants. Contact the research team at m.far@cliniqueovo.com for enrollment information.
Where is the NCT06997900 trial being conducted?
This trial is being conducted at Ottawa, Canada, Montreal, Canada.
Who is sponsoring the NCT06997900 clinical trial?
NCT06997900 is sponsored by Clinique Ovo. The trial plans to enroll 200 participants.