Comparison Between Two Different Protocols in Polycystic Ovary Symdrome Women Undergoing Intra-cytoplasmic Injection

What Was Tested

The trial (phase 4) is built around Leuprolide and Cetrorelix.

Stein and Leventhal were the first to recognize an association between the presence of polycystic ovaries and signs of hirsutism and amenorrhea (eg,oligomenorrhea, obesity), After women diagnosed with Stein-Leventhal syndrome underwent successful wedge resection of the ovaries, their menstrual cycles became regular, and they were able to conceive.

As a consequence, a primary ovarian defect was thought to be the main culprit, and the disorder came to be known as polycystic ovarian disease.

It had two arms (groups): Study group (experimental) and control group (active comparator).

The antagonist protocol group" where they will do intra-cytoplasmic injection using classical antagonist protocol.

"agonist stop/antagonist protocol group" where they will receive mid luteal agonist in the preceding intra-cytoplasmic injection cycle before starting classical antagonist protocol.

The registry classes the interventions as drug.

Who Took Part

150 planned participants were the target.

It was open to women only aged from 20 years up to 35 years.

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

Examples of who could join: Women under 35 years with polycystic ovary syndrome criteria. Normal male semen parameters. Normal tubes either by hysterosalpingography \&/or laparoscopy. Free from other endocrine abnormalities.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: NON polycystic ovary syndrome Criteria; more than 35 years; abnormal semen parameters.

How the Study Was Run

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

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

It started in 2019-12-07 with completion listed for 2020-10.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The difference in clinical pregnancy rate in both groups (time frame: 6 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide and Cetrorelix in 150 people.

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

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