A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction

What Was Tested

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

It had 1 arm (groups): Follitropin alfa injected by Pen device (experimental).

The registry classes the interventions as device.

Who Took Part

62 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Premenopausal and aged 18-40 years, inclusive. Normal Papanicolaou (PAP) smear within 6 months prior to initial visit. Patency and apparent normality of at least 1 fallopian tube with an ipsilateral functional ovary, as documented by an hysterosonogram or hysterosalpingography (HSG) within 3 years prior to study entry. Been willing and able to comply with the protocol for the duration of the study.

The full record lists 11 inclusion and 19 exclusion criteria; among the exclusions: known infection with human immunodeficiency virus (hiv), hepatitis b or c virus; prior severe ovarian hyperstimulation syndrome (ohss); ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-07 with completion listed for 2005-11.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of subjects who prefer Gonal-f® Pen device compared to previously used injection for gonadotropin treatment (time frame: Stimulation Day 6).

It also tracked 6 secondary outcomes, for example Number of subjects with categorical score on subject satisfaction questionnaire, Percentage of subjects with induced ovulation, Number of follicles categorized by size on r-hCG administration day, Duration of follitropin alfa treatment and Percentage of subjects with pregnancy.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of hCG (human chorionic gonadotropin) in 62 people.

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

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