HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles

What Was Tested

In this early phase 1 trial, researchers set out to test hCG (human chorionic gonadotropin).

It had two arms (groups): spontaneous LH (other) and HCG (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 300 actual participants took part.

It was open to women only aged from 18 years up to 36 years.

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

Examples of who could join: Age ≤ 36 years,. Regular menstrual cycles,. Body mass index (BMI) between 18 and 29 kg/m²,. Estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle, normal hysterosalpingography (maximum 3 months prior starting the cycle). The use of donor sperm was also accepted as inclusion criteria.

The full record lists 6 inclusion and 2 exclusion criteria.

How the Study Was Run

It was run as a randomized, single-group and double-blind study.

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

As a double-blind hCG (human chorionic gonadotropin) study, the assignments were hidden from both participants and investigators until the end.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and investigator.

It started in 2009-04 with completion listed for 2011-07.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): ongoing pregnancy rate (time frame: 1 year).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of hCG (human chorionic gonadotropin) in 300 people.

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

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.