Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes

Plain-language guide to NCT04852029: not phased randomized trial of hCG (human chorionic gonadotropin), female fertility, 12 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04852029
Phase: not phased
Status: terminated early
Start: 2021-08-16
Completion (planned or actual): 2021-12-31
Participants: 12 (actual)
Design: randomized, quadruple-blind, other
Conditions studied: Infertility, Female
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around hCG (human chorionic gonadotropin) for female fertility.

It had two arms (groups): Control Group (active comparator) and Intervention Group (experimental).

The registry classes the interventions as other.

Who Took Part

The registry lists 12 actual participants took part.

It was open to women only aged from 18 years up to 46 years.

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

Examples of who could join: Negative serum hCG prior to start of COH. BMI \>18 and \<35. Plan for ejaculated sperm use. Plan for PGT testing with euploid embryo transfer.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: concomitant menopur administration during ovarian stimulation or during frozen embryo transfer cycle; BMI \<18 or \>35; age \<18 or \>46.

How the Study Was Run

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

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.

Neither the female fertility participants nor the staff measuring them knew who was on hCG (human chorionic gonadotropin), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-08-16 with completion listed for 2021-12-31.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: sustained implantation rate (time frame: 8 weeks gestational age).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 12 people with female fertility.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, Female fertility research.

Our Notes on the Compound

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

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.