Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP

What Was Tested

In this not phased trial, researchers set out to test HMG (Human Menopausal Gonadotropin).

Follicular development were monitored until the protocol hCG requirement is met and a single injection of hCG was administered.

It had two arms (groups): one (experimental) and one (experimental).

This is a prospective randomized study using two in-label treatments for the patient disease: Pergoveris and Menopur. Pergoveris arms can be considered as experimental for the aim of the study, anyway it is standard routine practice for HH women.

This is a prospective randomized study using two in-label treatments for the patient disease: Pergoveris and Menopur. Menopur can be considered as experimental for the aim of the study, anyway it is standard routine practice for HH women.

The registry classes the interventions as drug.

More on the Plan

This results in abnormally low serum levels of Follicular Stimulation Hormone (FSH) and Luteinizing Hormone (LH) and negligible oestrogen (E2) activity.

The LH activity could be produced by LH itself or by human Chorionic Gonadotropin (hCG) and the two gonadotropins are available to be used in the WHO type I patients in two different formulations both in indication for this type of patients.

It would be worth of interest to assess if these two different formulations could elicit the same clinical outcomes in standard clinical practice or not.

After this, a single injection of hCG was administered in order to induce final oocyte maturation.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to women only aged from 25 years up to 36 years.

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

Examples of who could join: WHO Type I HH Women. Age 25-36 years. No ovarian tumor. ≤ 13 small follicles (mean diameter ≤ 10mm). BMI between 18 - 32 Kg/m2.

The full record lists 9 inclusion and 0 exclusion criteria.

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.

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.

It started in 2011-03 with completion listed for 2012-05.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: E2 in pmol/L (time frame: Day after the protocol hCG requirement is met (at least one follicle of 17mm is monitored by ultrasound)). Number of Follicles > 17mm (time frame: last US day before hCG administration). P4 in nmol/L (time frame: Day after the protocol hCG requirement is met (at least one follicle of 17mm by US)).

It also tracked 4 secondary outcomes, for example Endometrial thickness, Total number of Follicles and Clinical Pregnancy rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of HMG (Human Menopausal Gonadotropin) in 40 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.