Menopur And Rekovelle Combination Study Version 2.0

Launched by CLINIQUE OVO · May 21, 2025

Keywords

ClinConnect Summary

The Menopur and Rekovelle Combination Study is a clinical trial designed to test a new approach for helping women aged 18 to 40 who are experiencing fertility problems and are undergoing in vitro fertilization (IVF). The researchers want to see if personalizing the starting doses of two medications, Rekovelle and Menopur, based on a woman's age and weight leads to the same outcomes as using a more standard method that considers hormone levels and weight. Participants in this study will receive tailored doses of these medications, and their progress will be monitored through ultrasounds and blood tests while they go through the IVF process.

To be eligible for this trial, women should be between 18 and 40 years old, have regular menstrual cycles, and have certain types of infertility, such as unexplained infertility or mild endometriosis. They should also have both ovaries and be preparing for their first IVF cycle. It's important to note that women with specific medical conditions or who have had certain treatments may not qualify. If you participate, you can expect personalized care and thorough monitoring during your IVF journey, which aims to assess the safety and effectiveness of this new dosing strategy.

Gender

FEMALE

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