Actively Recruiting
Menopur And Rekovelle Combination Study Version 2.0
Led by Clinique Ovo · Updated on 2025-07-31
200
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
Sponsors
C
Clinique Ovo
Lead Sponsor
F
Ferring Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Menopur And Rekovelle Combination Study Version 2.0
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 40 years inclusive at the time of consent
- Diagnosed with unexplained infertility, tubal infertility, endometriosis stage I or II, or male factor infertility
- Regular menstrual cycles of 24 to 35 days
- Presence of both ovaries
- Early follicular phase FSH serum concentration less than 10 IU/L measured between Day 2 and Day 5 of menstrual cycle within the previous 24 months
- First IVF or ICSI cycle
- Prescribed IVF antagonist protocol
- Use of partner or donor ejaculated sperm (fresh or frozen) for fertilization
You will not qualify if you...
- Women undergoing oocyte donation
- Endometriosis stage III or IV
- High risk of ovarian hyperstimulation syndrome (AMH 35 pmol/L or higher)
- Body Mass Index greater than 40 kg/m2
- Gynecological hemorrhages of unknown cause
- History of three or more consecutive miscarriages
- Renal or hepatic impairment
- Hypersensitivity to follitropin delta or HP-hMG or their ingredients
- Tumors of hypothalamus or pituitary gland
- Ovarian enlargement or cysts not caused by polycystic ovarian syndrome
- Current or history of ovarian, uterine, or breast cancer
- History of thrombophilia
- Use of hormonal medications (except 17β-estradiol, testosterone gel, DHEA, and thyroid medication) during the last menstrual cycle
- Participation in any other interventional research project
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Ottawa fertility centre
Ottawa, Ontario, Canada
Actively Recruiting
2
Clinique ovo
Montreal, Quebec, Canada, H4P 2S4
Actively Recruiting
Research Team
M
Marya Far
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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