Timing of HCG Administration in IUI Cycles

What Was Tested

This registered phase 4 trial tested hCG (human chorionic gonadotropin).

Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.

It had three arms (groups): Group A (active comparator), Group B (active comparator) and Group C (active comparator).

IUI at time of HCG.

IUI 12 hours after HCG.

IUI 34-36 hours after HCG.

The registry classes the interventions as drug.

More on the Plan

Women will be randomly divided into 3 groups; the first group will undergo IUI at the time HCG administration, the second group will undergo IUI 12 hours after HCG administration and the third group will undergo IUI 34-36 hours after HCG administration.

Who Took Part

225 planned participants were the target.

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

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

Examples of who could join: Mild male factor infertility or unexplained infertility.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: advanced male factor infertility; polycystic ovary syndrome (pcos) as defined by the rotterdam criteria; tubal disease.

How the Study Was Run

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

Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when hCG (human chorionic 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 2015-01 with completion listed for 2019-07.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Clinical pregnancy rate (time frame: 4-6 weeks after IUI).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 225 people.

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, all human trials.