Dydrogesterone, Cetrorelix Acetate and Triptorelin in Intra Cytoplasmic Sperm Injection Outcomes

What Was Tested

The trial (phase 3) is built around Triptorelin and Cetrorelix.

It had three arms (groups): Dydrogesterone (experimental), GnRH antagonist (active comparator) and GnRH agonist (active comparator).

The registry classes the interventions as drug.

More on the Plan

Study Design: A randomized clinical trial (RCT).

Women will be recruited for enrollment when they come to fertility clinic and scheduled for ICSI trial.

They will be counseled and asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria.

Study Sample: The study consisted of 387 women which will be randomized into 3 groups.

Who Took Part

The registry lists 387 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: Having indications for ICSI.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: any known contraindications to the approved fertility drugs; severe endometriosis; uterine malformations or abnormal uterine cavity.

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 2023-07-15 with completion listed for 2023-12-31.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of oocytes retrieved (time frame: 1cycle (1 month)). maturity of oocytes retrieved (time frame: 1 cycle (1month)).

It also tracked 1 secondary outcome, for example Duration of stimulation.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin and Cetrorelix in 387 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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