Mild Stimulation Protocol Versus Microdose Gonadotropin-releasing Hormone Agonist Flare up Protocol in Poor Responders

What Was Tested

The trial (phase 4) is built around Buserelin.

Despite the progression in assisted reproductive technology (ART), the preferred protocol for poor responders is still controversial.

The response to controlled ovarian hyperstimulation (COH) is lower regarding estradiol level , number of obtained oocytes , and fertilization , implantation and pregnancy rates in patients with low ovarian reserve .

It had two arms (groups): clomiphene citrate,pregnancy,poor responders (experimental) and buserelin,pregnancy,poor responder (active comparator).

The registry classes the interventions as drug.

More on the Plan

Despite the progression in assisted reproductive technology (ART) , the preferred protocol for poor responders is still controversial.

The response to controlled ovarian hyperstimulation (COH) is lower regarding estradiol (E₂) level , number of obtained oocytes , and fertilization , implantation and pregnancy rates in patients with low ovarian reserve .

Materials and Methods Study design This study was a prospective randomized controlled trial including 159 poor responder patients who were candidate for IVF .

Women with ≥38 years old who had one or more previous failed IVF cycles in which three or fewer oocyte were been retrieved and/or serum E2 level on the day of hCG administration was ≤500 pg/ml were enrolled in this study .

Who Took Part

Enrollment: 159 actual participants took part.

It was open to women only aged from 38 years up to 45 years.

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

Examples of who could join: Women with ≥38 years old.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: BMI \> 30; endocrine disorders; metabolic disorders.

How the Study Was Run

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

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

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

In this single-blind Buserelin study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2009-04 with completion listed for 2009-08.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example and implantation rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Buserelin in 159 people.

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

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