Prediction of High Ovarian Response After Assisted Reproductive Techniques

NCT ID: NCT02358421

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

PCOS; OHSS

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Initial cohort

Patients at risk of developing OHSS according to the inclusion criteria

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vicente Montañana-Ramirez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigaciones Sanitarias La Fe

Locations

La Fe University Hospital

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Vicente Montañana-Ramírez, MD, PhD

Role: CONTACT

monti8121@yahoo.com

+34 961 245 841

Other Identifiers

Highresponse_ART

Identifier Type: -

Identifier Source: org_study_id