Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders

What Was Tested

The trial (phase 4) is built around Nafarelin.

Gonadotropin Releasing Hormone agonist (GnRHa) triggering is used as an alternative to human chorionic gonadotropin (hCG) in GnRH antagonist protocol to eliminate the risk of ovarian hyperstimulation syndrome (OHSS).

In order to preserve a high pregnancy rates, several luteal support regimens were investigated, including an intensive estrogen and progesterone supplementation and a daily GnRHa treatment.

It had two arms (groups): GnRHa treatment based luteal support (active comparator) and Estrogen and progesterone supplementation (active comparator).

The registry classes the interventions as drug.

More on the Plan

The administration of human chorionic gonadotropin (hCG) for final oocyte maturation is an accepted practice in in vitro fertilization (IVF) treatments.

In 2004, Tesarik et al, conducted a prospective randomized trial including 276 oocyte recipients.

Of note, the endometrium was prepared by oral estradiol valerate treatment following by vaginal progesterone (Utrogestan) as widely accepted.

A study by Pirard et al. was the first to evaluate the administration of GnRH agonist alone for luteal support compared to compared to the standard treatment with vaginal progesterone.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: High responder patients, defined as either reaching a serum estradiol levels of ≥ 3500 pg/ml on the day of trigger or having ≥ 15 oocytes retrieved.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: repeated implantation failure (3 or more previous failed embryo transfer cycles while transferring good quality embryos); oocyte donation, fertility preservation or freeze all (freezing all the embryos) cycles; moderate to severe endometriosis.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Nafarelin and who got the comparison, which limits bias.

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

Being open-label, the Nafarelin study did not mask who received what.

It started in 2017-12-29 with completion listed for 2021-09-30.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: clinical pregnancy rate (time frame: 3 weeks after positive serum bHCG results). Clinical pregnancy rate with fetal heart beat (time frame: 3 weeks after positive serum bHCG results).

It also tracked 2 secondary outcomes, for example Miscarriage rate and Ovarian hyperstimulation syndrome (OHSS) rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Nafarelin in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Nafarelin compound page, all human trials.