Human Chorionic Gonadotropin (hCG) Test: A Novel Method to Evaluate the Ovarian Reserve

Plain-language guide to NCT00646568: not phased interventional trial of hCG (human chorionic gonadotropin), 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00646568
Phase: not phased
Status: completed
Start: 2008-06
Completion (planned or actual): 2010-01
Participants: 60 (estimated)
Design: na, open label (everyone knows who gets what), diagnostic
Conditions studied: Infertility
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test hCG (human chorionic gonadotropin).

The current tests include serum FSH, Inhibin B, Mullerian inhibiting factor (MIF) and ultrasonographic measures such as ovarian volume and number of antral follicles are non-specific and with questionable reliability.

The biochemical tests represent the function of production of androgens, as a predictor of ovarian reserve, has not been tested yet.

The registry classes the interventions as drug.

More on the Plan

20 women \>40 years old and 20 women \<35 years old, attended to their IVF unit were included in the study.

Another 20 other young women (\<35 years) with poor response in previous IVF cycles will be participate.

Hormone levels of LH, FSH, E2, P, Testosterone, Androstendione and 17-OHP were taken prior to the injection and on days 1, 3 and 7 afterwards. hCG induced hormone levels will be compared with IVF results.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: All women on IVF cycle.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: any allergy to injection of human chorionic gonadotropin before.

How the Study Was Run

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

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the participants and staff both knew the treatment.

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

It started in 2008-06 with completion listed for 2010-01.

It ran at 1 site in Israel.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): androgens levels after stimulation in relation to the ovarian reserve (time frame: 2 weeks).

What This Means in Plain Language

Put simply, this is a not phased trial of hCG (human chorionic gonadotropin) in 60 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.

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.