Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test hCG (human chorionic gonadotropin) and Triptorelin.

This comparative study will help clinicians to select the relevant protocol of ovarian stimulation related to the female infertility disorders.

It had five arms (groups): Protocol "A" (active comparator), Protocol "B" (active comparator), Protocol "C" (active comparator), Protocol "D" (active comparator) and Protocol "E" (active comparator).

The registry classes the interventions as drug.

More on the Plan

One in six couples worldwide is affected by infertility, which defined as the inability to conceive after one year or more of regular and unprotected intercourse.

The desire to procreate is naturally present in women all over the world.

Due to various advances in medical procreation techniques, it has become possible for many women to realize their hope.

Who Took Part

200 actual participants took part.

It was open to women only aged from 21 years up to 44 years.

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

Examples of who could join: Must not show any of the excluded criteria. The selection of subjects' age must be group matched between protocols of treatment. Premature ovarian failure is defined as AMH (Anti Mullerian Hormone) ≤ 2 ng/mL. Willing to collaborate and to attend to the clinical follow-ups for the next three years. Patients willing to sign informed consent. Able and willing to comply with all study requirements.

The full record lists 12 inclusion and 4 exclusion criteria; among the exclusions: subjects to be excluded from the study if the male (husband) had any male infertility problem(s); patients with any genetic abnormalities; women aged 45 years and older, under 21 years.

How the Study Was Run

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

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

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2018-02-01 with completion listed for 2019-08-22.

It ran at 1 site in Lebanon.

Its stated primary purpose is health services research.

What Was Measured

Researchers chose this as the main measure: Ovulation Induction (time frame: 36 hours).

It also tracked 4 secondary outcomes, for example fertilization rate, embryo quality, pregnancy rate and live birth rate.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of hCG (human chorionic gonadotropin) and Triptorelin in 200 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 and the Triptorelin compound page, all human trials.