MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer

What Was Tested

This registered phase 3 trial tested HMG (Human Menopausal Gonadotropin).

It had two arms (groups): Highly Purified Menotrophin (experimental) and Recombinant FSH (active comparator).

The registry classes the interventions as drug.

More on the Plan

The use of oral contraceptives for programming of the trial cycle was prohibited.

On day 2-3 of the menstrual cycle, participants were randomized in a 1:1 fashion to treatment with either highly purified menotrophin (MENOPUR) or recombinant FSH, and stimulation was initiated.

Hereafter, the participants were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation.

Oocyte retrieval took place 36h (± 2h) after hCG administration.

Who Took Part

749 actual participants took part.

It was open to women only aged from 21 years up to 34 years.

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

Examples of who could join: Informed Consent Documents signed prior to screening evaluations. In good physical and mental health. Pre-menopausal females 21-34 years of age. Body mass index (BMI)18-25 kg/m2. Eligible for intracytoplasmic sperm injection (ICSI).

The full record lists 14 inclusion and 10 exclusion criteria; among the exclusions: known polycystic ovarian syndrome or known endometriosis stage i-iv; diagnosed as "poor responder" in a previous controlled ovarian stimulation (cos) cycle; severe ovarian hyperstimulation syndrome (ohss)in a previous cos cycle.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got HMG (Human Menopausal Gonadotropin) and who got the comparison, which limits bias.

The HMG (Human Menopausal Gonadotropin) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether HMG (Human Menopausal Gonadotropin) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2009-07 with completion listed for 2010-07.

It ran at 25 sites in Spain (6), Belgium (4), Denmark (4), Czechia (3), Sweden (3) and Turkey (Türkiye) (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set (time frame: 10-11 weeks after embryo transfer at the blastocyst stage). Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set (time frame: 10-11 weeks after embryo transfer at the blastocyst stage).

It also tracked 14 secondary outcomes, for example Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set, Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set, Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set, Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set, Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set and Endocrine Profile (Prolactin), Intention-to-treat (ITT) Analysis Set.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of HMG (Human Menopausal Gonadotropin) in 749 people.

With 749 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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