hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF

What Was Tested

In this phase 4 trial, researchers set out to test HMG (Human Menopausal Gonadotropin) for pcos.

There have been some controversies regarding the use of preparations with LH activity in patients with polycystic ovary syndrome (PCOS) who have high endogenous LH activity.

It had two arms (groups): menotrophin (active comparator) and recombinant FSH (active comparator).

The registry classes the interventions as drug.

More on the Plan

Polycystic ovary syndrome was diagnosed according to the Rotterdam criteria.

Patients older than 38 years or with serum FSH level ≥12mIU/ml and a history of ovarian surgery were excluded from the study.

All of their patients were given combined oral contraceptive (Yasmin) prior to ovulation induction cycles.

Serial Estrodiol (E2) levels and two-dimensional follicle measurements by transvaginal ultrasonography (LOGIC 200 PRO, General Electric, Korea) were performed until at least two dominant follicles reached dimensions of 18 mm or greater in diameter.

Who Took Part

80 actual participants took part.

It was open to women only aged from 20 years up to 38 years.

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

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: patients older than 38 years or with serum fsh level ≥12miu/ml and a history of ovarian surgery were excluded from the study.

How the Study Was Run

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

The pcos participants were allocated by chance, so the HMG (Human Menopausal Gonadotropin) 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 HMG (Human Menopausal Gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-01 with completion listed for 2008-06.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: the incidence of OHSS (time frame: 6 Months). peak serum E2 levels (time frame: 6 months).

It also tracked 3 secondary outcomes, for example the need of coasting,, number of intermediate follicles and fertilization rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in 80 people with pcos.

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

More context: the HMG (Human Menopausal Gonadotropin) compound page, PCOS research.