Effect of Luteal Progesterone Support on Pregnancy Rates With Combined Clomid/ Gonadotropin & IUI

Plain-language guide to NCT02510534: phase 1 randomized trial of HMG (Human Menopausal Gonadotropin), 520 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02510534
Phase: phase 1
Status: terminated early
Start: 2015-07
Completion (planned or actual): 2016-04
Participants: 520 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Pregnancy
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around HMG (Human Menopausal Gonadotropin).

It had two arms (groups): Control (active comparator) and Treatment (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patients will be randomized in a treatment arm or control arm.

The treatment arm receives the luteal progesterone support and the control arm does not.

Each arm will have 260 patients.

Who Took Part

Enrollment: 520 actual participants took part.

It was open to women only aged from 18 years up to 37 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: BMI 19-34 kg/m2. Estradiol (E2) less than 80 pg/mL. Anti-mullerian hormone (AMH) more than 1.5 ng/mL; or antral follicle count (AFC) up to 10. Two patent fallopian tubes confirmed by hysterosalpingogram (HSG) or chromopertubation. Normal uterine cavity confirmed by HSG, saline sonohysterogram (SIS) or hysteroscopy.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the HMG (Human Menopausal Gonadotropin) group and the comparison group should start out alike.

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

Nothing was hidden in this open-label HMG (Human Menopausal Gonadotropin) study: the participants and staff both knew the treatment.

It started in 2015-07 with completion listed for 2016-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect on Pregnancy rate measured by detectable embryonic cardiac activity (time frame: 10 months).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of HMG (Human Menopausal Gonadotropin) in 520 people.

With 520 participants it is a large trial for this field.

It ended early (terminated); 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.

Our Notes on the Compound

HMG (Human Menopausal Gonadotropin): Menotropins: a glycoprotein preparation that supplies follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity.

HMG (Human Menopausal Gonadotropin) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.