Comparative Study Between Minidose Long Protocol and Microdose Flare Protocol in Controlled Ovarian Hyperstimulation

What Was Tested

In this phase 3 trial, researchers set out to test Triptorelin.

Objective: To compare two stimulation protocols, the minidose long protocol and the microdose flare protocol designed for low responders undergoing ICSI.

Patients: 60 poor responder patients coming for IVF center for ICSI.

It had two arms (groups): Minidose long protocol (active comparator) and Microdose flare protocol (active comparator).

The registry classes the interventions as drug.

More on the Plan

Exclusion criteria: * Polycystic ovarian syndrome patients. * Patients with Endometriosis. * Normal responders to ovulation induction. * Patients having ovarian cyst. * Patients receiving ovulation induction in the preceding cycle.

The study was approved by Kasr El-Aini IVF center research committee.

Each patient had given informed consent after full explanation of the procedure.

Randomization was performed according to a computer generated list.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to women only aged from 35 years up to 42 years.

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

Examples of who could join: Age \> 35 years. Day 3 serum FSH level \> 10m IU/ml. Number of antral follicles measuring 4-8mm during the early phase \< 6. Small ovarian volume. AMH \< 1.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: polycystic ovarian syndrome patients; patients with endometriosis; normal responders to ovulation induction.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Triptorelin 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 Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2011-01 with completion listed for 2011-12.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Oocytes Retrieved (time frame: 12 months).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 60 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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