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Endometrial Advancement After Rec or u-HCG Triggering

Plain-language guide to NCT00953628: phase 4 randomized trial of hCG (human chorionic gonadotropin), endometriosis, 130 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00953628
Phase
phase 4
Status
completed
Start
2005-08
Completion (planned or actual)
2006-12
Participants
130 (actual)
Design
randomized, single-blind, treatment
Conditions studied
Infertility
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test hCG (human chorionic gonadotropin) for endometriosis.

The purpose of this study is to investigate any potential advantages of replacing human chorionic gonadotropin (uhCG) with recombinant human chorionic gonadotropin (recHCG) for final oocyte maturation with regard to Ovarian hyperstimulation syndrome (OHSS)pathophysiology, endometrium receptivity and embryo quality and clinical pregnancy.

It had two arms (groups): o Group A=uHCG ovul trig (active comparator) and o Group B=recHCG ovul trig (experimental).

HCG for triggering.

Recombinant HCG for triggering.

The registry classes the interventions as drug.

More on the Plan

Biopsies of endometrium were taken in different groups Pregnancy rates were compared among defferent groups.

Who Took Part

The registry lists 130 actual participants took part.

It was open to women only aged from 20 years up to 36 years.

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

Examples of who could join: Less than 36 years old. Male or tubal infertility. FSH\<12 on day 3.

The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: endometriosis stage 3 \& 4.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The endometriosis participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

In this single-blind hCG (human chorionic gonadotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2005-08 with completion listed for 2006-12.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): endometrium histology on the day of OPU (time frame: day of oocytre pick up).

It also tracked 1 secondary outcome, for example pregnancy rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 130 people with endometriosis.

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, 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.