Modified Luteal Support for Frozen-Thawed Embryo Transfer - A Prospective Study

What Was Tested

In this phase 4 trial, researchers set out to test hCG (human chorionic gonadotropin) and Triptorelin.

This study evaluates the outcomes of frozen-thawed embryo transfer (FET) success rate with modified luteal support - addition of a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively vs. traditional luteal support with vaginal progesterone only in ovulating women.

It had two arms (groups): Study group (experimental) and Control group (no intervention).

The usual progesterone only luteal phase support.

The registry classes the interventions as drug.

More on the Plan

There are several currently employed replacement protocols for FET.

The choice of protocol depends on the individual woman's ovarian function and convenience of the method, as well as on the experience gained with the method by the physicians.

Whatever protocol is used, the success requires optimal synchronization between the embryonic stage at thawing and date of the endometrium within the endometrial preparation cycle.

Starting on the day of spontaneous ovulation, patients received daily vaginal progesterone, supplemented by a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively.

Who Took Part

The registry lists 62 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: 20-40 years old women. Spontaneously ovulating women. Treated in their IVF unit for frozen-thawed embryo transfer. At least one top quality embryo.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: PGD patients; more than 4 previous embryo transfers.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

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

Neither the 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 and care provider.

It started in 2016-07 with completion listed for 2017-06.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Ongoing pregnancy (time frame: About 10-12 weeks after embryo transfer).

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

What This Means in Plain Language

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

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 and the Triptorelin compound page, all human trials.