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Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer

Plain-language guide to NCT01643993: not phased randomized trial of hCG (human chorionic gonadotropin), 300 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01643993
Phase
not phased
Status
completed
Start
2012-05
Completion (planned or actual)
2014-01
Participants
300 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Control Media Only; Study hCG and Media
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).

However, in IVF cycles, the embryos have limited time to secrete hCG before implantation must occur because embryos are placed into the uterus rather than traveling there from the fallopian tubes.

It had two arms (groups): hCG at Time of Embryo Transfer (experimental) and Control (other).

The registry classes the interventions as other.

Who Took Part

300 actual participants took part.

It was open to women only aged from 18 years up to 43 years.

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

Examples of who could join: All patients 43 years old or under undergoing fresh or frozen IVF cycles are eligible to participate.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: patients greater than 43 years old; patinets currently participating in any other research studies.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

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

It started in 2012-05 with completion listed for 2014-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Sustained implantation rate (time frame: 12 weeks).

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

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 300 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.

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.