NCT06997900

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
15mo left

Started Jul 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Jul 2025Aug 2027

First Submitted

Initial submission to the registry

May 21, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 4, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

May 21, 2025

Last Update Submit

July 29, 2025

Conditions

IVFControlled Ovarian SimulationFertility Disorders

Outcome Measures

Primary Outcomes (1)

  • number of good quality (>3BB) or utilizable blastocysts per treatment cycle at day 5 or 6 of embryo culture

    5 to 6 days after egg retrieval (up to 1 to 2 months after enrollment)

Secondary Outcomes (1)

  • Safety profile of follitropin delta + HP-hMG mixed protocol

    up to 15 days after egg retrieval

Study Arms (1)

Follitropin delta and HP-hMG

EXPERIMENTAL
Drug: Combination therapy : Follitropin delta and HP-hMG

Interventions

Combination therapy : Follitropin delta and HP-hMGDRUG

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

Follitropin delta and HP-hMG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify 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
  • First IVF/ICSI cycle
  • IVF antagonist protocol prescribed
  • Partner or donor ejaculated sperm (fresh or frozen) used for fertilization

You may not qualify 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ottawa fertility centre

Ottawa, Ontario, Canada

RECRUITING

Clinique ovo

Montreal, Quebec, H4P 2S4, Canada

RECRUITING

Related Publications (1)

  • Bissonnette F, Minano Masip J, Kadoch IJ, Librach C, Sampalis J, Yuzpe A. Individualized ovarian stimulation for in vitro fertilization: a multicenter, open label, exploratory study with a mixed protocol of follitropin delta and highly purified human menopausal gonadotropin. Fertil Steril. 2021 Apr;115(4):991-1000. doi: 10.1016/j.fertnstert.2020.09.158. Epub 2020 Nov 30.

    PMID: 33267959BACKGROUND

Central Study Contacts

Marya Far

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 31, 2025

Study Start

July 4, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)