Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).

What Was Tested

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

Multicenter, prospective, randomized, investigator blind, controlled clinical trial.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 144 planned participants were the target.

It was open to women only aged from 18 years up to 36 years.

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

Examples of who could join: Women undergoing ovarian stimulation for IVF with or without ICSI (intracytoplasmic sperm injection) and with the following characteristics:. Voluntary given informed consent to study participation in writing encompassing consent to data recording and verification procedures;. \> 18/= and \< 37 years old;. BMI between 18 and 28 kg/m2;. Less than 3 previous completed IVF cycles;.

The full record lists 8 inclusion and 17 exclusion criteria; among the exclusions: primary ovarian failure or women known as poor responders;; signs of pco, according to the rotterdam criteria;; at least one ovary inaccessible for oocyte retrieval;.

How the Study Was Run

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

The participants were allocated by chance, so the HMG (Human Menopausal Gonadotropin) group and the comparison group should start out alike.

The HMG (Human Menopausal Gonadotropin) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether HMG (Human Menopausal Gonadotropin) was given.

It started in 2005-05 with completion listed for 2008-05.

It ran at 2 sites in Italy (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: total number of oocytes retrieved 34 - 36 hours after hCG administration.

It also tracked 4 secondary outcomes, for example number of mature oocytes and inseminated oocytes; fertilization rate, embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate and Tolerability evaluation.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of HMG (Human Menopausal Gonadotropin) in 144 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.