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Frozen Embryo Transfer (FET) in Natural Cycles or in Natural Cycles Controlled by Human Chorionic Gonadotropin (hCG) Administration

Plain-language guide to NCT00809107: not phased randomized trial of hCG (human chorionic gonadotropin), 150 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00809107
Phase
not phased
Status
completed
Start
2006-10
Completion (planned or actual)
2008-07
Participants
150 (estimated)
Design
randomized, open label (everyone knows who gets what), 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).

The rational of the study is to assess the implantation, pregnancy and live birth rates after the transfer of frozen- thawed embryos in natural cycles with spontaneous Luteinizing Hormone (LH)/Progesterone rise or in natural cycles controlled by human chorionic gonadotropin (hCG) for final oocyte maturation and ovulation.

It had two arms (groups): 1 (experimental) and 2 (no intervention).

HCG GROUP.

LH pick.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 150 planned participants were the target.

It was open to women only aged from 17 years up to 40 years.

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

Examples of who could join: Day 3 embryo transfers. Previously IVF or ICSI.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: irregular cycles; oocyte donation cycles.

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.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2006-10 with completion listed for 2008-07.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Implantation rate (time frame: 2 years).

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 150 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.