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HCG (Human Chorionic Gonadotropin) Priming for Thin Endometrium in IVF (in Vitro Fertilization)

Plain-language guide to NCT01768247: phase 4 interventional trial of hCG (human chorionic gonadotropin), endometriosis, 15 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01768247
Phase
phase 4
Status
status unknown
Start
2012-01
Completion (planned or actual)
2013-12
Participants
15 (estimated)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Endometrial Thickness; Pregnancy Outcome
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) for endometriosis.

It had 1 arm (groups): HCG priming (experimental).

Patients in this arm after 7-9 days of estrogen replacement they will receive a 150 international units (IU) HCG every day for 7 days concomitantly with the estradiol.

The registry classes the interventions as drug.

More on the Plan

In this pilot study subjects with repeatedly resistant thin endometrium, less than 6mm, will be recruited.

Who Took Part

15 planned participants were the target.

It was open to women only aged from 30 years up to 50 years.

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

Examples of who could join: (1) Less than 6mm endometrial thickness before, (2) at least two failed implantations before.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: abnormal uterine cavity in hysteroscopy.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

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

It started in 2012-01 with completion listed for 2013-12.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Endometrial thickness (time frame: 14 days after estrogen treatment).

It also tracked 1 secondary outcome, for example Pregnancy outcome.

What This Means in Plain Language

Put simply, this is a phase 4 trial of hCG (human chorionic gonadotropin) in 15 people with endometriosis.

Its size is small, so on its own it can only give an early look.

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, Endometriosis research.

Our Notes on the Compound

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

Related Pages

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.