PCOS Clinical Trial
— HighARTOfficial title:
High Response Predictive Parameters After Controlled Ovarian Stimulation in Women Undergoing Assisted Reproductive Techniques
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
Inclusion criteria: Patients with primary infertility undergoing ovarian stimulation for IVF/ICSI plus one of the following criteria: 1. Ovulation dysfunction. 2. Androgen excess: clinical and/or biochemical. 3. Polycystic ovary by transvaginal ultrasound in early follicular phase. 4. AMH>35 pmol/l 5. FSH/LH<1 6. P4 levels on the day of menstrual cycle <10ng/ml and cycle duration <26 days 7. 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: 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) |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Spain | La Fe University Hospital | Valencia |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigacion Sanitaria La Fe |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Prevalence of metabolic syndrome in the cohort of included patients | 18 months | After COH for ART | No |
Secondary | Incidence of metabolic syndrome in patients with at least one criterion of PCOS | 15 years in average | No | |
Secondary | Incidence of cardiiovascular events in patients with at least one criterion of PCOS | 15 years in average | No |
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