Menopur And Rekovelle Combination Study Version 2.0
Clinique Ovo
200 participants
Jul 4, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria14
- 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
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Interventions
Follitropin delta dose will be determined by age. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06997900