Recruiting
Phase 2

Rekovelle & Menopur

Sponsor:

Clinique Ovo

Code:

NCT06997900

Conditions

IVF

Controlled Ovarian Simulation

Fertility Disorders

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Combination therapy : Follitropin delta and HP-hMG

Study Details

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 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

IVF

Controlled Ovarian Simulation

Fertility Disorders

Study ID

NCT06997900

Start date

Jul 4, 2025

Status verified date

Jul, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Follitropin delta and HP-hMG

Interventions

Combination therapy : Follitropin delta and HP-hMG

Follitropin delta dose will be determined by age. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight.

Primary outcome measure

  • number of good quality (>3BB) or utilizable blastocysts per treatment cycle at day 5 or 6 of embryo culture [ Time Frame: 5 to 6 days after egg retrieval (up to 1 to 2 months after enrollment) ]

Central Contacts and Locations

Central contacts

Marya Far

514-798-2000m.far@cliniqueovo.com

Locations

Ottawa fertility centre

Recruiting

Ottawa, Ontario, Canada

Principal Investigator:

Jenna Gale, MD

Clinique ovo

Recruiting

Montreal, Quebec, Canada, H4P 2S4

Principal Investigator:

Isaac-Jacques Kadoch, MD

More Information

Sponsor

Clinique Ovo

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Clinique Ovo on 2025-07-31.