Prediction of High Ovarian Response After Assisted Reproductive Techniques (HighART)
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|ClinicalTrials.gov Identifier: NCT02358421|
Recruitment Status : Unknown
Verified January 2015 by Instituto de Investigacion Sanitaria La Fe.
Recruitment status was: Recruiting
First Posted : February 9, 2015
Last Update Posted : February 9, 2015
Polycystic ovarian syndrome (PCOS) patients have an increased risk of ovarian hyperstimulation syndrome (OHSS) after assisted reproduction techniques (ART). In addition, these women have a high risk of develop further metabolic disorders. Rotterdam criteria defined by the European Society of Human Reproduction and Endocrinology (ESHRE) are used for the diagnosis of PCOS.
The aim of this study is both to determine the prevalence of PCOS in infertile patients who require ART in our Center and to evaluate the usefulness of each specific diagnosis criterium within Rotterdam criteria of PCOS as predictor of risk of OHSS. It also seeks to establish a cohort of patients identified according to specific Rotterdam criteria of PCOS to assess the incidence of long term complications.
|Condition or disease|
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women. It affects 10 % of patients who undergo assisted reproductive techniques (ART). Rotterdam criteria defined by the European Society of Human Reproduction and Endocrinology (ESHRE) are used for the diagnosis of PCOS. According to such criteria, PCOS affects 5-10% of women of reproductive age.
Patients with PCOS according to the Rotterdam criteria, as well as those with polycystic ovaries by ultrasound, have a high risk of an exaggerated response to ovulation induction therapy. Complications of the ovarian hyperstimulation syndrome (OHSS) include hemoconcentration, thromboembolic disorders, electrolyte disorders, ascites, hydrothorax, ovarian torsion, respiratory failure, liver failure, kidney failure or even death.
There is a lack of reliable markers that indicate risk of OHSS. It is also unknown whether any specific criteria proposed in the Rotterdam consensus is more important than another or independently influence on the results of the ARTs.
The aim of this study is both to determine the prevalence of PCOS in infertile patients who require ART in our Center and to evaluate the usefulness of each specific diagnosis criteria of PCOS as predictor of risk of OHSS. It also seeks to establish a cohort of patients identified according to specific Rotterdam criteria of PCOS to assess the incidence of long term complications.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||30 Months|
|Official Title:||High Response Predictive Parameters After Controlled Ovarian Stimulation in Women Undergoing Assisted Reproductive Techniques|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2015|
Patients at risk of developing OHSS according to the inclusion criteria
- Sensitivity, specificity, negative and positive predictive values of each inclusion criteria (independently and combined) to predict OHSS and high ovarian response after ART [ Time Frame: 18 months ]
- Prevalence of metabolic syndrome in the cohort of included patients [ Time Frame: After COH for ART ]18 months
- Incidence of metabolic syndrome in patients with at least one criterion of PCOS [ Time Frame: 15 years in average ]
- Incidence of cardiiovascular events in patients with at least one criterion of PCOS [ Time Frame: 15 years in average ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358421
|Contact: Vicente Montañana-Ramírez, MD, PhD||+34 961 245 email@example.com|
|La Fe University Hospital||Recruiting|
|Valencia, Spain, 46026|
|Principal Investigator: Vicente Montañana-Ramírez, MD, PhD|
|Sub-Investigator: César Díaz-García, MD|
|Sub-Investigator: José María Rubio-Rubio, MD, PhD|
|Sub-Investigator: Patrocinio Polo, MD, PhD|
|Sub-Investigator: Alicia Martínez-Varea, MD|
|Sub-Investigator: Antonio Pellicer, MD, PhD|
|Principal Investigator:||Vicente Montañana-Ramirez, MD, PhD||Instituto de Investigaciones Sanitarias La Fe|