Prediction of High Ovarian Response After Assisted Reproductive Techniques

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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High Response Predictive Parameters After Controlled Ovarian Stimulation in Women Undergoing Assisted Reproductive Techniques

Conditions
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PCOS, OHSS

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with primary infertility undergoing ovarian stimulation for IVF/ICSI plus one of the following criteria: Ovulation dysfunction. Androgen excess: clinical and/or biochemical. Polycystic ovary by transvaginal ultrasound in early follicular phase. AMH>35 pmol/l FSH/LH<1 P4 levels on the day of menstrual cycle <10ng/ml and cycle duration <26 days Patients who undergo a second cycle after a previous one in which they were considered high responders (the cycle was canceled due to high risk of OHSS or the patient underwent coasting) Exclusion Criteria: Age <18 or >39 years FSH >10 Uterine fibroids requiring surgery Diagnosis of hyperprolactinemia , hypothyroidism, congenital adrenal hyperplasia, Cushing's syndrome, ovarian tumors, adrenal tumors or hypogonadotropic hypogonadism Intake of oral contraceptives three months prior to the completion of IVF Diagnosis of endometriosis (by ultrasound or surgical findings)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Initial cohort<br>Patients at risk of developing OHSS according to the inclusion criteria | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Incidence of cardiiovascular events in patients with at least one criterion of PCOS |  | 15 years in average | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotterdam's diagnostic criteria of PCOS, Risk of OHSS