Actively Recruiting

Phase 2
Age: 18Years - 40Years
FEMALE
ID06997900

Menopur and Rekovelle Combination Study Version 2.0 for Personalized Ovarian Stimulation in IVF

Led by Clinique Ovo · Updated on 2025-07-31

200

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

Clinique Ovo

Lead Sponsor

F

Ferring Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a personalized ovarian stimulation regimen for women aged 18 to 40 undergoing in vitro fertilization (IVF). This study aims to determine if adjusting the starting doses of follitropin delta (REKOVELLE) and highly purified human menopausal gonadotropin (HP-hMG or MENOPUR) based on age and body weight results in similar clinical outcomes as dosing based on anti-Müllerian hormone (AMH) and weight. This phase II interventional trial builds on previous studies showing benefits of combining these hormones for ovarian stimulation. Participants will receive a combination therapy where REKOVELLE dosing is personalized according to age, and MENOPUR dosing is determined based on the REKOVELLE dose and body weight. This differs from earlier protocols that used fixed doses. Throughout the treatment, participants will undergo ovarian stimulation followed by standard IVF procedures including egg retrieval and embryo assessment. During the study, participants will be monitored through ultrasound imaging and blood tests to measure hormone levels such as estradiol. The main measurement is the number of good quality or usable blastocysts five to six days after egg retrieval. Safety outcomes, including the risk of ovarian hyperstimulation syndrome, will also be tracked up to 15 days post-retrieval. The trial is designed to assess the feasibility and safety of this new dosing approach over the course of one treatment cycle.

CONDITIONS

Brief Title

Menopur And Rekovelle Combination Study Version 2.0

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Women undergoing oocyte donation
  • Endometriosis stage III/IV
  • High risk of OHSS (AMH ≥ 35 pmol/L)
  • Body Mass Index (BMI) > 40 kg/m2
  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 to 2 months after enrollment, including stimulation and egg retrieval phases

Participants receive combination therapy with follitropin delta and highly purified human menopausal gonadotropin (HP-hMG) for personalized ovarian stimulation in IVF.

Approximately 1 baseline visit and multiple visits during ovarian stimulation, egg retrieval, and embryo culture

Follow-up

Duration - Up to 15 days after egg retrieval

Participants are monitored for safety outcomes, including the risk of ovarian hyperstimulation syndrome (OHSS), up to 15 days after egg retrieval.

Approximately 1 to 2 post-treatment visits

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

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Research Team

M

Marya Far

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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Published Research Related To This Trial

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.

Francois Bissonnette, Jaume Minano Masip, Isaac-Jacques Kadoch...

https://pubmed.ncbi.nlm.nih.gov/33267959