Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Poly Cystic Ovary Syndrome ( PCOS )

Plain-language guide to NCT02551367: phase 2 randomized trial of hCG (human chorionic gonadotropin), pcos, 110 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02551367
Phase: phase 2
Status: status unknown
Start: 2015-10
Completion (planned or actual): 2016-05
Participants: 110 (estimated)
Design: randomized, single-blind, treatment
Conditions studied: Anovulation; Polycystic Ovary Syndrome
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested hCG (human chorionic gonadotropin) for pcos.

Patients will be subjected to: Complete history taking: 1.

Details about name, age 2.

It had two arms (groups): letrozole (experimental) and clomiphene citrate (active comparator).

The registry classes the interventions as drug.

More on the Plan

Primary or secondary infertility 3.

Known or suspicious tubal factor infertility ( by hysteroslapingograrhy (HSG) or laparoscope. 6.

Endometrioses or pelvic inflammatory diseases .

Details a bout name, age 2.

Who Took Part

The registry lists 110 planned participants were the target.

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

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

Examples of who could join: Age between 20-35. Primary or secondary infertility.

The full record lists 3 inclusion and 13 exclusion criteria; among the exclusions: male factor of infertility; ph 7.2 to 8.0; liquefaction time 20 to 30 min.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

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

In this single-blind hCG (human chorionic gonadotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2015-10 with completion listed for 2016-05.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: ovulation rate (time frame: up to 24 weeks).

It also tracked 4 secondary outcomes, for example day 21 progesterone level, Endomertial thickness, On gowing pregnancy and Chemical pregnancy.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of hCG (human chorionic gonadotropin) in 110 people with pcos.

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

More context: the hCG (human chorionic gonadotropin) compound page, PCOS research.

Our Notes on the Compound

hCG (human chorionic gonadotropin): An LH analog that drives Leydig-cell testosterone production.

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.