A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique

What Was Tested

In this phase 3 trial, researchers set out to test hCG (human chorionic gonadotropin).

This is a phase IIIb, interventional, multicenter, multinational, randomised, open-label, comparative trial which primary objective is to generate data on the ovarian stimulation profile obtained when Luveris® is started either on Day 1 or Day 6 in women in advanced reproductive age (36-42) undergoing Assisted Reproductive Technique (ART).

It had two arms (groups): Gonal-f®+Luveris® (experimental) and Gonal-f® Followed by Luveris® (experimental).

The registry classes the interventions as biological and drug.

More on the Plan

The subjects who complete the screening assessments and fulfil all the eligibility criteria will start down-regulation treatment on day 21-22 of the cycle.

Down-regulation treatment must start within 2 months following the screening visit.

The routine long luteal phase protocol for Gonadotrophin-releasing hormone (GnRH) agonist treatment will be followed.

Once down-regulation has been confirmed, a pregnancy test will be performed within 1 week prior to start of Recombinant human follicle stimulating hormone (r-hFSH) treatment to rule out any pre-existing pregnancy.

Who Took Part

The registry lists 174 actual participants took part.

It was open to women only aged from 36 years up to 42 years.

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

Examples of who could join: Should be a female subject justifying an In Vitro Fertilization/Embryo transfer (IVF)/ET treatment. Should be between 36th and 42nd birthday (both included) at the time of the randomization visit. Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length. Presence of both ovaries. Normal uterine cavity, which in the investigator's opinion is compatible with Pregnancy.

The full record lists 11 inclusion and 20 exclusion criteria; among the exclusions: had previous severe ovarian hyperstimulation syndrome (ohss); presence of endometriosis requiring treatment; uterine myoma requiring treatment.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when hCG (human chorionic 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 2012-05 with completion listed for 2014-01.

It ran at 1 site in United Arab Emirates.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation (time frame: 34-38 hours post r-hCG administration).

It also tracked 10 secondary outcomes, for example Total Number of Stimulation Treatment Days, Implantation Rate, Number of Fetal Sacs With Activity, Number of Fetal Sacs With Detectable Heart Beats, Total Pregnancy Rate and Clinical Pregnancy Rate and Cycle Cancellation Rate Prior to r-hCG.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) in 174 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.