GnRH-a and Pregnancy Rate in In Vitro Fertilization (IVF) Cycles.

What Was Tested

The trial (not phased) is built around Leuprolide for endometriosis.

The investigators attempted to establish a rationale for the Gonadotropin Releasing Hormone-agonist (GnRH-a) administration, post-laparoscopically, in women with mild endometriosis (until stage II, according to AFS) who underwent IVF-ET procedure.

It had three arms (groups): Endometriosis, leuprolide, IVF (active comparator), Endometriosis, IVF (active comparator) and Tubal infertility, IVF (active comparator).

Women with stage II endometriosis received GnRH-a (leuprolide) prior to an IVF attempt.

Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.

Women with tubal infertility underwent an IVF attempt.

The registry classes the interventions as drug and procedure.

More on the Plan

The study population consisted of 120 infertile women (more than a year of sexual attempts), aged 29-38 years, with laparoscopically documented endometriosis referred to the In Vitro Fertilization (IVF) Unit of the Department for infertility treatment during a 7-years period (May 2004 to September 2010).

In addition, in the current study, the researchers used 60 women with tubal infertility, documented by laparoscopy, without prior history of ovarian surgery, hydrosalpinx, and/or endometriosis as control group.

This group was used to see if endometriosis affect the women's fertility.

The participant's enrolment was made by three following authors A.K., K.Z., and M.P.

Who Took Part

180 actual participants took part.

It was open to women only aged from 29 years up to 38 years.

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

Examples of who could join: Mild endometriosis (until stage II).

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: ovarian endometrioma \> 2 cm; FSH \> 12 mIU/ml; mail factor infertility.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Leuprolide study: the endometriosis participants and staff both knew the treatment.

It started in 2004-05 with completion listed for 2010-08.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Clinical Pregnancy Rate (time frame: June 2004-August 2010). Embryo Quality (the Percentage of Grade 1 Embryos Per Participant) (time frame: June 2004-August 2010). Fertilization Rate (Percentage of Fertilized Oocytes) (time frame: June 2004-August 2010).

It also tracked 1 secondary outcome, for example Follicular Fluid's TNF-a Concentration.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Leuprolide in 180 people with endometriosis.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, Endometriosis research.