The Effect of Pre-treatment With GnRH Analogues Prior in Vitro Fertilization in Patients With Endometriosis
Condition: Endometriosis; Infertility
MeSH terms: Infertility; Endometriosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the administration of an analogue of
      gonadotropin-releasing hormone (GnRH) during the three months prior to the performing of an
      IVF may improve the response to ovarian stimulation, implantation rate and clinical pregnancy
      rate in patients with endometriosis/ endometriomas.
    

Detailed description: 
      Endometriosis is defined as the presence of ectopic endometrial tissue which induces a local
      inflammatory reaction. Usually, this tissue is located at any level in the pelvic region, but
      extrapelvic locations have been described. It is a chronic disease whose cause is unknown,
      although a genetic predisposition has been proven. It is estimated that endometriosis affects
      7-15% of women of fertile age, and up to 30-40% of women with endometriosis have infertility.

      Assisted reproduction techniques (ART) are the treatment of many causes of infertility,
      including endometriosis. The results of assisted reproduction in women with endometriosis
      appear to be somewhat worse than those obtained from women without endometriosis. Some
      authors have proven a significant reduction in implantation and pregnancy rates in these
      patients.

      The worst pregnancy rate and implantation is believed to be originated in a poor oocyte
      quality, which can lead to a lower rate of fertilization. This poor oocyte quality produce
      poorer quality embryos with a reduced capacity to implant, particularly in severe
      endometriosis.

      On the other hand, endometrial receptivity does not appear to contribute to the reduction of
      results of ART in these women.

      In an attempt to improve ART outcomes in women with endometriosis, different strategies have
      been proposed prior to the cycle realization, with different results.

      Surgical resection of endometriomas (endometriosis cysts) before the cycle of IVF/ICSI may
      adversely affect the results. On the other hand, careful laparoscopic cystectomy appears not
      to affect the ovarian response to stimulation.

      In addition to surgical approaches, have been tried different medical treatments to improve
      the results of IVF / intracytoplasmatic sperm injection (ICSI) in women with endometriosis.
      It has been suggested that treatment with Danazol prior to IVF may improve results.
      Similarly, prolonged treatment with GnRH analogues few months before IVF could improve the
      implantation and pregnancy rates. Unfortunately, many of these studies were not randomized
      and / or controlled so that the true value of therapy with GnRH analogues before IVF in women
      with endometriosis still needs to be valued. A recent meta-analysis showed that a 3-6 month
      treatment with GnRH analogues before IVF increased 4 times the odds of clinical pregnancy in
      women with endometriosis. Nevertheless, these results were concluded from 165 patients and 78
      pregnancies, included in 3 clinical trials, which was not specifically to patients with
      endometriomas.

      The lack of studies with proper design, suggests that there is insufficient evidence at
      present to establish firm recommendations in this regard. This study will contribute to
      increasing scientific evidence to recommend or not pretreatment with GnRH agonists before IVF
      en patients with endometriosis.
    

Intervention name(s): Triptorelin acetate
Intervention type(s): Drug
Intervention description(s): Triptorelin acetate Dosing regimen: 1 subcutaneous injection of 3,75 mg/28 days, total of 3 doses
Placebo Dosing regimen: subcutaneous injection of the same volume of physiological serum/28 days, total of 3 doses
Other intervention name(s): Gonapeptyl Depot 3,75
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endometriosis; GnRH treatment; Infertility; IVF