PROtecting Ovaries and Fertility During Chemotherapy - The PROOF Trial

What Was Tested

The trial (phase 3) is built around Leuprolide.

The purpose of this study is to determine whether gonadotropin releasing hormone agonists (medical therapy) will protect against ovarian failure in reproductive aged women undergoing sterilizing chemotherapy.

It had two arms (groups): Placebo (placebo comparator) and one (active comparator).

Placebo.

The registry classes the interventions as drug.

More on the Plan

Fertility preservation is defined as the maintenance of one's ability to reproduce.

The hypothesis for this study is that medical treatment (GnRHa) will help female cancer patients, receiving sterilizing chemotherapy, preserve their ovarian function and therefore fertility.

This study is a feasibility trial of the drug (GnRHa)vs placebo in female cancer patients receiving gonadotoxic chemotherapy between the ages of 18 and 38 who wish to participate.

The same protocol will be followed as proposed for the definitive trial but with a smaller sample size.

Who Took Part

30 actual participants took part.

It was open to women only aged from 18 years up to 38 years.

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

Examples of who could join: Women who are:. Between ages 18 to 38;. Who will be undergoing gonadotoxic (sterilizing) curative/ adjuvant chemotherapy for early stage disease; and.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: women who:; have advanced stage disease and/or whose median survival is expected to be less than 6 months; have cancer of the ovaries, uterus, or fallopian tubes;.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Leuprolide, so expectations could not easily colour the readings.

It started in 2007-01 with completion listed for 2010-01.

It ran at 4 sites in Canada (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Protection against ovarian failure (time frame: 12 months post Chemo therapy).

It also tracked 1 secondary outcome, for example Sonographic (biophysical) and biochemical markers of ovarian reserve.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.