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Comparative Study of Long-acting and Short Acting Triptorelin in PCOS Patients Who Underwent IVF/ICSI

Plain-language guide to NCT02477566: not phased randomized trial of Triptorelin, pcos, 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02477566
Phase
not phased
Status
status unknown
Start
2014-12
Completion (planned or actual)
2016-12
Participants
200 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
In Vitro Fertilization; Polycystic Ovary Syndrome
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Triptorelin for pcos.

It had two arms (groups): Long-acting Triptorelin (experimental) and Short-acting Triptorelin (active comparator).

The registry classes the interventions as drug.

More on the Plan

All patients received standard ovarian stimulation with rFSH under pituitary suppression with GnRH agonist according to a protocol used routinely.

Transvaginal ultrasound and E2 measurement were used to monitor follicular growth, and gonadotropin dosages were adjusted accordingly.

Serum HCG value were measured at 12 h after HCG trigger using the immunoassay.

Oocytes were retrieved 36 h after the injection of HCG.

Who Took Part

The registry lists 200 planned participants were the target.

It was open to women only aged from 22 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: PCOS patients diagnosis by Rotterdam Consensus on Diagnostic Criteria who underwent IVF/ICSI treatment.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: patients with poor ovarian reserve,; immunological disease,; uterine abnormality,.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

Neither the pcos participants nor the staff measuring them knew who was on Triptorelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2014-12 with completion listed for 2016-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Clinical pregnancy rate (time frame: 2 years).

It also tracked 1 secondary outcome, for example moderate/severe OHSS rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Triptorelin in 200 people with pcos.

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

More context: the Triptorelin compound page, PCOS research.

Our Notes on the Compound

Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.