Prediction of High Ovarian Response After Assisted Reproductive Techniques

NCT02358421 | Unknown

• 1 other identifier: Highresponse_ART
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS; OHSS

Keywords

Rotterdam's diagnostic criteria of PCOS; Risk of OHSS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Prevalence of metabolic syndrome in the cohort of included patients

  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

Study Arms (1)

Initial cohort

Patients at risk of developing OHSS according to the inclusion criteria

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

La Fe University Hospital

Valencia, Valencia, 46026, Spain

RECRUITING

Study Officials

• Vicente Montañana-Ramirez, MD, PhD

  Instituto de Investigaciones Sanitarias La Fe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicente Montañana-Ramírez, MD, PhD

CONTACT

+34 961 245 841; monti8121@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: February 9, 2015
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 9, 2015

Record last verified: 2015-01

Locations

ES (1)