Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome

What Was Tested

This registered phase 4 trial tested Gonadorelin.

Polycystic ovary syndrome (PCOS) patients are often accompanied by infertility.

Non-obese PCOS infertility is more difficult to treat than obese PCOS.

The study included non-obese PCOS patients who had not recovered from regular menstruation after six months of metformin treatment.

It had two arms (groups): Pulsatile Gonadotropin-releasing Hormone (experimental) and Clomiphene (experimental).

Use Clomiphene for 3 months to treat PCOS.

The registry classes the interventions as drug.

More on the Plan

By using GnRH pulse therapy and Clomiphene therapy. the investigators will intervent the participants for 3 months and to compare outcome in each group.

Who Took Part

Enrollment: 78 planned participants were the target.

It was open to women only aged from 24 years up to 45 years.

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

Examples of who could join: PCOS of childbearing age (24-45 years old);. No drug intervention except metformin was used in last 3 monthes:. There is a pregnancy plan within 1 years. The pregnancy test was negative. Heart and liver function is normal, thyroid function is normal, adrenal function is normal.

The full record lists 10 inclusion and 12 exclusion criteria; among the exclusions: PCOS was not diagnosed; other serious organic heart diseases, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, nyha cardiac function grade (\> iii);; kallmann syndrome, secondary hypogonadotropic hypogonadism, acquired central nervous system diseases, infertility caused by hypothalamic amenorrhea and other secondary infertility;.

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 Gonadorelin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2019-07-01 with completion listed for 2020-12-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of participants with ovulation recovery (according to basal body temperature, progesterone levels on cycle day 21, or ultrasonography) (time frame: up to 12 weeks).

It also tracked 1 secondary outcome, for example Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Gonadorelin in 78 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Gonadorelin compound page, all human trials.