Comapring Luteal Phase Support in IVF Patients Who Are at High Risk for Developing OHSS

What Was Tested

The trial (not phased) is built around hCG (human chorionic gonadotropin) and Triptorelin.

The purpose of this study is to compare two luteal support protocols in In vitro fertilization patients (IVF) and are at risk of developing ovarian hyperstimulation syndrome (OHSS).

It had two arms (groups): Decapeptyl support (experimental) and hCG luteal support (active comparator).

The registry classes the interventions as drug.

More on the Plan

This is randomized clinical trial studying two luteal support protocols of In vitro fertilization patients (IVF) treated by a GnRH antagonist (GnRH ant) protocol and are at risk of developing ovarian hyperstimulation syndrome (OHSS).

The randomization procedure will be performed by a third party in the hospital by using a randomization table: patients fulfilling the inclusion and exclusion criteria and giving their informed consent will be randomized into one of two arms.

This study does not include any intervention affecting the ovarian stimulation and is solely intended to test the post ova pickup period.

One arm will be treated by luteal Decapeptyl on days 3, 6,9 post ovulation triggering.

Who Took Part

Enrollment: 50 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: GnRH antagonist protocol. GnRH agonist triggering of ovulation. High risk for OHSS as expressed by either E2 serum level \>2500 pg/ml.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: background maternal morbidity; any protocol other than gnrh antagonist protocol; hcg triggering of ovulation.

How the Study Was Run

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

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

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

Only one side, usually the participants, was kept unaware of whether hCG (human chorionic gonadotropin) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2016-08 with completion listed for 2017-08.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progesterone serum level (time frame: day 5 post ovum pickup).

It also tracked 3 secondary outcomes, for example positive pregnancy test, implantation rate and clinical pregnancy rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) and Triptorelin in 50 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.