Status:
RECRUITING
Menopur And Rekovelle Combination Study Version 2.0
Lead Sponsor:
Clinique Ovo
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
IVF
Controlled Ovarian Simulation
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
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 quest...
Detailed Description
In vitro fertilization (IVF) is a multi-step process that includes controlled ovarian stimulation, oocyte retrieval, fertilization, and embryo transfer. Success in IVF largely depends on how the ovari...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06997900
Start Date
July 4 2025
End Date
August 1 2027
Last Update
July 31 2025
Active Locations (2)
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1
Ottawa fertility centre
Ottawa, Ontario, Canada
2
Clinique ovo
Montreal, Quebec, Canada, H4P 2S4