Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles

What Was Tested

The trial (phase 3) is built around Triptorelin and Nafarelin.

The development of stimulation protocols for in vitro fertilisation (IVF) has led to a paradox.

It has now been established that obtaining a large number of oocytes is a key to success, but that it is also a risk factor for embryo transfer failure after puncture (disruption of endometrial receptivity due to luteal insufficiency) and a risk factor for complications such as ovarian hyperstimulation syndrome (OHSS).

It had two arms (groups): Ovulation triggering with hCG + Luteal phase support with vaginal progesterone (active comparator) and Ovulation triggering with Triptorelin + Luteal phase support with Nafarelin (experimental).

The registry classes the interventions as drug.

More on the Plan

It is currently established that obtaining a large number of oocytes is a key of success in IVF/ICSI cycles.

However, it is also a risk factor for ovarian hyperstimulation syndrome (OHSS) and a risk factor of implantation failure after fresh embryo transfer because of the alteration of endometrial receptivity.

A freeze all strategy can be proposed to avoid these risks but vitrification of embryos, although more efficient than slow freezing in terms of embryo survival, is not without risk.

Furthermore, proper endometrial and embryo timing for frozen-thawed embryo transfer is still debated.

Who Took Part

Enrollment: 652 planned participants were the target.

It was open to women only aged from 18 years up to 39 years.

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

Examples of who could join: Patients requiring conventional IVF or IVF with sperm injection (ICSI) from the partner or donor under the conditions of management defined by French law. Patients aged 18 to 39 included. First or second attempt at IVF or ICSI for pregnancy. BMI \< 35 kg/m2. AMH \< 5 ng/ml and/or antral follicle count \<40 within the year prior to inclusion.

The full record lists 11 inclusion and 20 exclusion criteria; among the exclusions: patient diagnosed with hiv infection; ICSI with sperm from testicular biopsy; pre-implantation diagnosis.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

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

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

It started in 2024-06-27 with completion listed for 2027-09.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Live birth, defined as the presence of a live birth after 22 weeks' gestation. Twin pregnancies will be counted as a single birth (time frame: 22 weeks' gestation).

It also tracked 29 secondary outcomes, for example Embryo implantation defined as the presence of a gestational sac on the first ultrasound (5-8 WG), Clinical pregnancy, defined as an intrauterine gestational sac with embryo showing cardiac activity on ultrasound at 5-10 WG, Miscarriage prior to 12 WG, defined as the termination of a pregnancy prior to 12 WG, Number of patients with gravidic hypertension and its onset,, Number of patients with pre-eclampsia and its onset, and Number of patients with gestational diabetes and its onset.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin and Nafarelin in 652 people.

With 652 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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