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New treatment option for IVF
Official title Menopur And Rekovelle Combination Study Version 2.0
ClinicalTrials.gov ID: NCT06997900
What this study is testing
What is Combination therapy : Follitropin delta and HP-hMG?
Combination therapy : Follitropin delta and HP-hMG is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for ivf.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 ?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 treatment research project
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.