The aim of this phase 4 trial is to assess if a single dose of a gonadotrophin-releasing hormone (GnRH) agonist enhances implantation during in vitro fertilization (IVF). The main outcome to be measured is the rate of live births. This study is being conducted in New Jersey, in the United States.
The details
In very early pregnancy, an embryo must successfully implant in the uterine lining (endometrium) at the correct time. During IVF patients are routinely administered a hormone called progesterone, to improve the chances of the fertilized embryo becoming implanted in the endometrium.
Recent data has shown that incorporating a single dose of a GnRH agonist into the IVF strategy may enhance implantation rates. This study will evaluate if GnRH agonist treatment results in an increased live birth rate.
Who are they looking for?
The study will recruit approximately 350 women (aged 18-40) undergoing IVF/intracytoplasmic sperm injection (ICSI) or frozen embryo transfers (FET).
Patients undergoing day 3 embryo transfers cannot be included in the trial.
How will it work
Patients will be randomly assigned to 2 groups. One group will receive a single dose of a GnRH agonist in addition to the standard IVF additional support regime. The other group will receive placebo (substance with no active effect).
The live birth per embryo transfer will be the main outcome. The time frame for this will be 9 months. Additional outcomes will include the implantation rate and the rate of clinical pregnancy. The time frame for these outcomes is 4 weeks.
