Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer in Women With Previous IVF Failure

Plain-language guide to NCT02329197: phase 4 randomized trial of hCG (human chorionic gonadotropin), 380 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02329197
Phase: phase 4
Status: status unknown
Start: 2014-10
Completion (planned or actual): 2015-10
Participants: 380 (estimated)
Design: randomized, double-blind, treatment
Conditions studied: Infertility; Invitro Fertilization
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around hCG (human chorionic gonadotropin).

Women with history of previous IVF cycle failure will be subjected to a fresh IVF cycle.

It had two arms (groups): Group A (experimental) and Group B (no intervention).

Women undergoing IVF treatment will embryo transfer procedure performed in the standard way without intrauterine injection of HCG.

The registry classes the interventions as drug.

More on the Plan

Infertile women with history of previous IVF cycle failure will be subjected top a fresh IVF cycle.

Who Took Part

The registry lists 380 planned participants were the target.

It was open to women only aged from 19 years up to 40 years.

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

The full record lists 0 inclusion and 1 exclusion criteria; among the exclusions: women with hydrosalpinges women with intrauterine lesion like submucous fibroid or polyps.

How the Study Was Run

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

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.

Blinding on both sides kept the participants and researchers unaware of who received hCG (human chorionic gonadotropin).

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2014-10 with completion listed for 2015-10.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Live Birth (time frame: 9 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 380 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.

Our Notes on the Compound

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

hCG (human chorionic gonadotropin) in the library

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.