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The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles

Plain-language guide to NCT01780610: not phased randomized trial of hCG (human chorionic gonadotropin), endometriosis, 670 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01780610
Phase
not phased
Status
status unknown
Start
2012-01
Completion (planned or actual)
2015-01
Participants
670 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Infertility
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested hCG (human chorionic gonadotropin) for endometriosis.

At present, there is still no sufficient evidence that which kind of frozen embryo transfer cycle regimen to plan more advantage.

The purpose of this study was to compare the pregnancy outcome of hormone replacement therapy cycles (HRT) and ovulation induced cycles (OI) in women with irregular cycles.

It had two arms (groups): group OI-A (other) and group HRT-B (other).

The registry classes the interventions as drug.

More on the Plan

This study is a prospective randomized controlled trial.

They will be randomized to receive either the OI-FET cycle (group OI-A) or the HRT-FET cycle (group HRT-B).

Transfer of thawed embryos will be performed 3 days later.

Who Took Part

Enrollment: 670 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age forty years old or less. Frozen embryos number more than three.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: has chocolate cyst or adenomyosis of uterus; clear hydrosalpinx; uterine scar or intrauterine adhesion and endometrial thickness \<7mm before ovulation.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

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

Only one side, usually the endometriosis participants, was kept unaware of whether hCG (human chorionic gonadotropin) was given.

Those kept unaware of assignments: participant.

It started in 2012-01 with completion listed for 2015-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): ongoing pregnancy rate (time frame: 12 weeks after pregnancy).

It also tracked 2 secondary outcomes, for example pregnancy rate and clinical pregnancy rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 670 people with endometriosis.

With 670 participants it is a large trial for this field.

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.