Menopur and Rekovelle combination for personalized ovarian stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.