Prediction of High Ovarian Response After Assisted Reproductive Techniques

PCOS Clinical Trial

— HighART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02358421
• Other study ID #: Highresponse_ART
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2014
• Last updated: February 3, 2015
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: Vicente Montañana-Ramírez, MD, PhD
• Phone: +34 961 245 841
• Email: monti8121[@]yahoo.com
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• OHSS
• PCOS

Locations

Country	Name	City	State
Spain	La Fe University Hospital	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe

Country where clinical trial is conducted

Spain, 

Outcome

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