Androgenic Profile Following Controlled Ovarian Stimulation

What Was Tested

This registered phase 4 trial tested HMG (Human Menopausal Gonadotropin).

In this study the investigators will try to discover whether there is a difference for any of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris \& luveris) vs. human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of androgenic hormones profile.

The study question is whether using recombinant LH will result in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using highly purified urinary gonadotropins with hCG mimicking LH activity.

It had two arms (groups): Recombinant preparations (active comparator) and HP-HMG (active comparator).

Highly purified human menopausal gonadotropin.

The registry classes the interventions as drug.

More on the Plan

ABSTRACT: The optimal controlled ovarian stimulation (COH) protocol is yet to be decided and most probably there is no right protocol that is optimal for all patients.

In contrast to LH activity in HMG which is mainly due to hCG rather than from LH, using r-LH provides true, consistent and precise LH activity.

In the present study the investigators aim to elucidate whether there is a difference for any of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris \& luveris) vs. human menopausal gonadotropin (menopur) during GnRH-antagonist cycles.

MATERIALS \& METHODS: Study design - A non-intervention observational trial.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: Infertile women between 20-40 years of age. Undergoing their 1-4 IVF cycle.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: suspected pcos; history of ohss.

How the Study Was Run

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

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 2016-12 with completion listed for 2018-01.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Serum hormonal profile. Follicular fluid hormonal profile (time frame: Ovum pick up day).

It also tracked 9 secondary outcomes, for example Implantation rate, Clinical pregnancy, Biochemical pregnancy, Ongoing pregnancy, Live birth rate and Number of follicles.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of HMG (Human Menopausal Gonadotropin) in 100 people.

Its status is unknown; 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.