Human Reproduction Unit of the La Fe University and Politechnic Hospital
Valencia, 46026, Spain
NCT Number: NCT01581359
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.
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Notify Me18 year–40 year
Female
Interventional
Phase 4
Valencia, 46026, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Gonapeptyl Depot 3,75
Time frame: 2 weeks after biochemical diagnosis of pregnancy
Number of pregnancies with fetal hearth beat on ultrasound exam divided by total number of started cycle
Time frame: In the moment of oocyte retrieval
Time frame: Two-three days after oocyte recovery and IVF
Time frame: Day of the Basal ultrasound
Total number in each ovary, uni or bilateral cysts and maximum diameter (mm) of the biggest endometrioma
Time frame: 37 weeks after cycle
Number of deliveries at 37th to 41st weeks of pregnancy divided by total number of pregnancies
Time frame: 22nd week of pregnancy
Number of pregnancy losses divided by total number clinical pregnancies
Time frame: 37th to 41st weeks of pregnancy
Number of healthy and live births divided by total number of started cycle
Time frame: Two days after oocyte recovery and IVF
Number of cleavage embryos divided by total number of metaphase II oocytes
Time frame: Day of the administration of human chorionic gonadotropin (hCG)
Total dose of gonadotropins in IU, and total days on treatment
Time frame: Last day of gonadotropin treatment
Number of cancelled cycles divided by total number or started cycles
Time frame: One month after hCG
Number of patients diagnosed of OHSS divided by ended cycles. Classification in mild, moderate and severe
Instituto de Investigacion Sanitaria La Fe
Other
A Comparative Study, Randomized, Blinded, About the Effect of Pre-treatment With GnRH Analogues Versus Placebo in Infertile Patients With Endometriosis Undergoing in Vitro Fertilization Treatment
Acronym: ENDOFIV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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