Prediction of High Ovarian Response After Assisted Reproductive Techniques

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02358421

Acronym

HighART

Enrollment

300

Registered

2015-02-09

Start date

2013-10-31

Completion date

2015-12-31

Last updated

2015-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OHSS, PCOS

Keywords

Rotterdam's diagnostic criteria of PCOS, Risk of OHSS

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 39 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
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	—

Countries

Spain

Contacts

Primary ContactVicente Montañana-Ramírez, MD, PhD

monti8121@yahoo.com+34 961 245 841

Outcome results