Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

What Was Tested

This registered phase 3 trial tested HMG (Human Menopausal Gonadotropin).

These findings provide a strong rationale for a definitive large RCT.

It had two arms (groups): Corifollitropin alfa followed by hpHMG (experimental) and recombinant FSH (active comparator).

The registry classes the interventions as drug.

More on the Plan

Recently, the European Society of Human Reproduction and Embryology developed a new definition in order to select patients suitable for inclusion in future clinical trials as poor ovarian responders, the so-called "Bologna criteria".

However, a limited number of studies has been published to date including patients with poor ovarian response according to the "Bologna criteria", whereas no randomized trial is published or ongoing for this population.

Preliminary reports in "Bologna poor responders" highlight the limited prospects for these women.

Who Took Part

Enrollment: 150 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 less than 40 years. Fulfillment of the "Bologna criteria" for poor ovarian response. Women \< 40 years old AND ≤3 oocytes in one of the previous cycles AND (Antral follicle count \<7 or antimullerian hormone serum values \<1.1 ng/ml). Women \<40 years old and ≤3 oocytes in two the previous cycles with maximum ovarian stimulation.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: uterine abnormalities; recent history of any current untreated endocrine abnormality; unilateral or bilateral hydrosalpinx (visible on transvaginal ultrasound, unless clipped).

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.

Being open-label, the HMG (Human Menopausal Gonadotropin) study did not mask who received what.

It started in 2013-03 with completion listed for 2016-05.

It ran at 2 sites in Belgium (1) and Vietnam (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Ongoing pregnancy (time frame: 9-10 weeks of gestation).

It also tracked 3 secondary outcomes, for example Clinical pregnancy, Biochemical pregnancy and Number of oocytes retrieved.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of HMG (Human Menopausal Gonadotropin) in 150 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.