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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial cohort | Patients at risk of developing OHSS according to the inclusion criteria |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity, negative and positive predictive values of each inclusion criteria (independently and combined) to predict OHSS and high ovarian response after ART | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of metabolic syndrome in the cohort of included patients | 18 months | After COH for ART |
| Incidence of metabolic syndrome in patients with at least one criterion of PCOS | 15 years in average |
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Inclusion criteria:
Patients with primary infertility undergoing ovarian stimulation for IVF/ICSI plus one of the following criteria:
Exclusion Criteria:
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Patients with primary infertility at risk of developing ovarian hyperstimulation syndrome during controlled ovarian hyperstimulation. This population was defined according to the presence of at least one Rotterdam criterion or the presence of an abnromal luteal phase, invesion of the FSH/LH ratio or an increased AMH level (see inclusion and exclusion criteria below)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicente Montañana-Ramírez, MD, PhD | Contact | +34 961 245 841 | monti8121@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Vicente Montañana-Ramirez, MD, PhD | Instituto de Investigaciones Sanitarias La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Fe University Hospital | Recruiting | Valencia | Valencia | 46026 | Spain |
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| Incidence of cardiiovascular events in patients with at least one criterion of PCOS | 15 years in average |