Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination.

What Was Tested

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

The present study aims to elucidate if the FSH and LH activity contained in hMG preparations is comparable to the recombinant FSH and LH administration in a 1:1 ratio.

It had two arms (groups): Group A (active comparator) and Group B (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 80 planned participants were the target.

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

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

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: ovarian policystic syndrome; severe endometriosis; uterine disease (polyps, myomas, intracavitarios, malformations…).

How the Study Was Run

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

Because people in this HMG (Human Menopausal Gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2009-01 with completion listed for 2009-05.

It ran at 2 sites in Spain (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The present study aims to elucidate if the FSH and LH activity contained in hMG preparations is comparable to the recombinant FSH and LH administration in proporción 1:1. Mean outcome: - Ovarian response according to the protocol used (time frame: one month).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in 80 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.