Menopur And Rekovelle Combination Study Version 2.0

What Was Tested

The trial (phase 2) is built around HMG (Human Menopausal Gonadotropin).

It had 1 arm (groups): Follitropin delta and HP-hMG (experimental).

The registry classes the interventions as drug.

More on the Plan

In vitro fertilization (IVF) is a multi-step process that includes controlled ovarian stimulation, oocyte retrieval, fertilization, and embryo transfer.

Success in IVF largely depends on how the ovaries respond to stimulation using exogenous gonadotropins.

Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are key to folliculogenesis and oocyte maturation, and are central to ovarian stimulation protocols.

This is a prospective, interventional, phase II clinical trial enrolling 200 participants across two fertility centers in Canada.

Who Took Part

200 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. First IVF/ICSI cycle.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: women undergoing oocyte donation; endometriosis stage iii/iv; 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.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the HMG (Human Menopausal Gonadotropin) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-07-04 with completion listed for 2026-08.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main 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)).

It also tracked 1 secondary outcome, for example Safety profile of follitropin delta + HP-hMG mixed protocol.

What This Means in Plain Language

Put simply, this is a phase 2 trial of HMG (Human Menopausal Gonadotropin) in 200 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the HMG (Human Menopausal Gonadotropin) compound page, all human trials.