Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility

What Was Tested

The trial (phase 4) is built around HMG (Human Menopausal Gonadotropin).

Ovulation disorders are a common cause of infertility in women.

Most of these women can be classified as World Health Organization (WHO) Group II anovulatory patients as they have irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation hormone (FSH) and estradiol.

It had 1 arm (groups): Ovulation induction (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 75 actual participants took part.

It was open to women only aged from 18 years up to 39 years.

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

Examples of who could join: Age 18 - 39 years. Anovulation with oligomenorrhoea (\> 35 days of mean cycle length) or amenorrhoea. BMI \< 35. First FSH/HMG cycle at the Fertility clinic. A sperm sample compatible with conception or semen from a donor.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: A history of \>12 ovulation induction cycles without achieving pregnancy; known hyperprolactinaemia or any other endocrine disturbance or systemic disease of the pituitary gland, thyroid gland, adrenal gland, pancreas, liver or kidney; undiagnosed vaginal bleeding.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-12 with completion listed for 2012-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The proportion of patients who reach the criteria for hCG-administration within 14 days of FSH stimulation (time frame: 14 days of FSH stimulation).

It also tracked 1 secondary outcome, for example Endocrinological characteristics and follicular dynamics of anovulatory infertility WHO Group II.

What This Means in Plain Language

Put simply, this is a phase 4 trial of HMG (Human Menopausal Gonadotropin) in 75 people.

The trial is marked completed; 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.