COMPARING TWO PROTOCOLS FOR FINAL OOCYTE MATURATION IN POOR RESPONDERS UNDERGOING GnRH-ANTAGONIST ICSI CYCLES

What Was Tested

The trial (phase 3) is built around Triptorelin.

It had two arms (groups): Group(A) (experimental) and Group(B) (experimental).

The registry classes the interventions as drug.

More on the Plan

Two of these criteria are required for a POR diagnosis.

In addition, two cycles with POR after maximal stimulation are sufficient to classify a patient as a poor responder even in the absence of other criteria mentioned.

So far, most of the modifications had limited success, therefore, optimal protocol for poor responders has remained elusive.(7) ESHRE in 2019 stated GnRH antagonists and GnRH agonists are equally recommended for predicted low responders.

(8) Final oocyte maturation trigger is one of the most important key success factors in assisted reproductive technologies (ARTs).

Who Took Part

The registry lists 160 planned participants were the target.

It was open to women only aged from 19 years up to 45 years.

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

Examples of who could join: Women with a spontaneous normal menstrual cycle and a normal uterine cavity. Body mass index (BMI) \< 35. Age less than 45. Anti-Mullerian Hormone (AMH) ≤ 1.1 ng/ ml. Antral Follicle Count (AFC) ≤ 7 follicles.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: comorbidities including, hypertension, diabetes mellitus or other endocrinopathies; surgically retrieved sperms; communicating hydrosalpinx.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Triptorelin study: the participants and staff both knew the treatment.

It started in 2022-06-01 with completion listed for 2022-12-01.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of metaphase II oocytes retrieved (time frame: On 1 day of oocyte retrieval).

It also tracked 13 secondary outcomes, for example Total number of oocytes, Ratio between number of follicles seen on day of trigger and number of oocytes retrieved, Maturity index, Fertilization rate, Cancellation rate and Number of obtained embryos.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 160 people.

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

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