Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.

What Was Tested

The trial (phase 3) is built around HMG (Human Menopausal Gonadotropin).

It had two arms (groups): hMG (experimental) and Placebo (placebo comparator).

Human Menopausal Gonadotropin, daily subcutaneous injection.

Placebo, daily subcutaneous injection.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 659 planned participants were the target.

It was open to women only aged from 18 years up to 42 years.

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

Examples of who could join: Pre-menopausal women aged 18-42 years old at the time of consent. BMI ≥18 and \<38 kg/m² at the time of consent. Menstrual cycles between 21-35 days. Normal mammogram or breast ultrasound if patient is \>40 or if participant is younger as indicated by physician recommendation, within 2 years of screening. Anti-Müllerian hormone (AMH) \>1.2 ng/ml within 6 months of screening.

The full record lists 18 inclusion and 38 exclusion criteria; among the exclusions: persistent (for \>1 cycle), clinically relevant (per pi discretion) ovarian cystic lesion (≥20 mm), including ovarian endometrioma or dermoid cyst; greater than one ivf cycle canceled due to inability to meet ovulation trigger criteria (i.e. at least 2-3 follicles reach ≥18 mm.); known history of anovulation.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this HMG (Human Menopausal Gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind HMG (Human Menopausal Gonadotropin) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-11-01 with completion listed for 2028-11.

It ran at 16 sites in United States (16).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: cumulative live birth rate (time frame: 12 months).

It also tracked 26 secondary outcomes, for example Positive pregnancy (serum β-human chorionic gonadotropin [hCG]), Clinical pregnancy (intrauterine gestational sac with fetal heartbeat), Ongoing pregnancy (intrauterine pregnancy with fetal heartbeat), Live birth rate, Number of oocytes retrieved per stimulation cycle and Number of metaphase II (MII) oocytes retrieved.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of HMG (Human Menopausal Gonadotropin) in 659 people.

With 659 participants it is a large trial for this field.

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.