Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI

What Was Tested

This registered phase 4 trial tested Triptorelin and Cetrorelix for pcos.

Patients will be divided into two groups Group A; patients using long protocol and freeze all embryos Group B; patients using antagonist protocol with fresh embryo transfer Patients will be carefully chosen according to a strict inclusion and exclusion criteria after meticulous revision of patient files.

It had two arms (groups): Long GnRH agonist (active comparator) and GnRH antagonist (active comparator).

The registry classes the interventions as drug.

More on the Plan

Cycle cancellation was decided when transvaginal ultrasound scan on cycle day (9) revealed no adequate follicular growth (\<3 mature follicles),if no oocytes were retrieved on ovum pick up,or if failure of fertilization occurred.

If signs of early OHSS were observed at 3rd day of ovum pickup ,cancellation of ET was done with elective embryo cryopreservation as it may end with life-threatening OHSS .

ET was cancelled also if any criteria of hospital admission was found.

Who Took Part

Enrollment: 204 actual participants took part.

It was open to women only aged from 20 years up to 39 years.

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

Examples of who could join: PCOS diagnosed by Roterdam criteria. Protocol used for ovulation induction either long procol with freeze all embryos vs antagonist with fresh embryo transfer. BMI less than 30.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: PCOS on long protocol with fresh embryo transfer and those on antagonist protocol with freezing all embryo; BMI more than 30; PCOS patients not given adjuvant drugs in prophylaxis of OHSS.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The pcos participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

Groups ran in parallel: each of the pcos 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 2017-04-21 with completion listed for 2017-11-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): clinical pregnancy rate (time frame: 4 weeks after embryo transfer).

It also tracked 4 secondary outcomes, for example chemical pregnancy rate, abortion rate, Ovarian hyperstimulation syndrome and Late Ovarian hyperstimulation syndrome.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin and Cetrorelix in 204 people with pcos.

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

More context: the Triptorelin compound page and the Cetrorelix compound page, PCOS research.