Prediction of High Ovarian Response After Assisted Reproductive Techniques

• Conditions: OHSS; PCOS

• Registration Number: NCT02358421
• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe

Brief Summary

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

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-03-21
• Status Verified: 2015-01
• Study First Submitted QC: 2015-02-03
• Last Update Submitted: 2015-02-03
• Study First Posted: 2015-02-09
• Last Update Posted: 2015-02-09
• Primary Completion: 2015-07
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

1. Age <18 or >39 years
2. FSH >10
3. Uterine fibroids requiring surgery
4. Diagnosis of hyperprolactinemia , hypothyroidism, congenital adrenal hyperplasia, Cushing's syndrome, ovarian tumors, adrenal tumors or hypogonadotropic hypogonadism
5. Intake of oral contraceptives three months prior to the completion of IVF
6. Diagnosis of endometriosis (by ultrasound or surgical findings)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Prevalence of metabolic syndrome in the cohort of included patients	After COH for ART	18 months
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

Trial Locations

Locations (1)

La Fe University Hospital; 🇪🇸 Valencia, Spain