Prediction of High Ovarian Response After Assisted Reproductive Techniques (HighART)

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.

Study Overview

• Status: Unknown
• Conditions: PCOS; OHSS

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Vicente Montañana-Ramírez, MD, PhD; Phone Number: +34 961 245 841; Email: monti8121@yahoo.com

Study Locations

• Spain
  • Valencia, Spain, 46026
    • Recruiting
    • La Fe University Hospital
    • Principal Investigator: Vicente Montañana-Ramírez, MD, PhD
    • Sub-Investigator: César Díaz-García, MD
    • Sub-Investigator: José María Rubio-Rubio, MD, PhD
    • Sub-Investigator: Patrocinio Polo, MD, PhD
    • Sub-Investigator: Alicia Martínez-Varea, MD
    • Sub-Investigator: Antonio Pellicer, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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)

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Initial cohort; Patients at risk of developing OHSS according to the inclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Investigators: Principal Investigator: Vicente Montañana-Ramirez, MD, PhD, Instituto de Investigaciones Sanitarias La Fe

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 9, 2015

Study Record Updates

• Last Update Posted (Estimate): February 9, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Rotterdam's diagnostic criteria of PCOS; Risk of OHSS
• Other Study ID Numbers: Highresponse_ART