Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women

What Was Tested

The trial (phase 3) is built around hCG (human chorionic gonadotropin).

Ovulation induction therapy will be undertaken with follitropin alfa.

It had two arms (groups): MSJ-0011 (experimental) and urinary hCG (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 81 actual participants took part.

It was open to women only aged from 20 years up to 39 years.

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

Examples of who could join: Premenopausal women aged between 20 to 39 years inclusive and wishing to conceive. Body Mass Index (BMI) of 17.0 to 29.0 kilogram per square meter (kg/m\^2) inclusive (value up to first decimal place). Anovulation or oligo-ovulation. Any one of the following: spontaneous menstruation (at least twice per year) or a positive response to progestin as evidenced by menstruation. Eligible for ovarian stimulation with gonadotropins (e.g. documented failure to ovulate or achieve pregnancy with anti-estrogenic therapy such as clomiphene citrate).

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: subjects with known surgical/histological diagnosis of endometriosis greater than stage ii (american fertility society classification), or endometriosis requiring treatment; infertility secondary to amenorrhea of uterine cause; infertility secondary to primary or premature ovarian failure.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-09 with completion listed for 2014-11.

It ran at 6 sites in Japan (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Subjects With Ovulation Mid-luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 5 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy (time frame: Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment).

It also tracked 4 secondary outcomes, for example Mid-luteal Endometrial Thickness, Percentage of Participants With Biochemical Pregnancy and Percentage of Participants With Clinical Pregnancy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) in 81 people.

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

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.