Frozen-thawed Embryo Transfer in a Natural Cycle: hCG Triggering Versus LH Home Test

What Was Tested

This registered phase 4 trial tested hCG (human chorionic gonadotropin).

It had two arms (groups): Pregnyl (Human chorionic gonadotropin) (experimental) and Home ovulation test (other).

The patients randomized to the LH surge group perform the ovulation home test daily from the urine. Thus, the ovulation in this group is corfimed by the urine test. The day of transferring embryo is depending on the positive ovulation test and the age of the embryo. The day zero day is defined by positive ovulation test.

The registry classes the interventions as drug and other.

More on the Plan

The aim of this study is to find out the best method for the ovulation triggering.

The researchers study the live birth rates in the both groups.

Who Took Part

Enrollment: 62 actual participants took part.

It was open to women only aged from 18 years up to 42 years.

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

Examples of who could join: \- Patient with IVF or ICSI cycle and therefore having frozen-thawed embryos. Regular menstruation cycle. Patient's willingness to participate in the study.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: \- irregular menstrual cycle demanding preparing endometrium with hormones for frozen-thawed embryo; no frozen embryos after ivf cycle; allergy to pregnyl® or some of its ingredients in the medication or other contraindications due to pregnyl®.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-01 with completion listed for 2019-11.

It ran at 1 site in Finland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Live birth rate (time frame: At possible delivery (about 40 weeks)).

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

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 62 people.

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, all human trials.