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

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ClinicalTrials.gov Identifier: NCT02358421
Recruitment Status : Unknown
Verified January 2015 by Instituto de Investigacion Sanitaria La Fe.
Recruitment status was:  Recruiting
First Posted : February 9, 2015
Last Update Posted : February 9, 2015
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

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.


Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Months
Official Title: High Response Predictive Parameters After Controlled Ovarian Stimulation in Women Undergoing Assisted Reproductive Techniques
Study Start Date : October 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

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



Primary Outcome Measures :
  1. Sensitivity, specificity, negative and positive predictive values of each inclusion criteria (independently and combined) to predict OHSS and high ovarian response after ART [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Prevalence of metabolic syndrome in the cohort of included patients [ Time Frame: After COH for ART ]
    18 months

  2. Incidence of metabolic syndrome in patients with at least one criterion of PCOS [ Time Frame: 15 years in average ]
  3. Incidence of cardiiovascular events in patients with at least one criterion of PCOS [ Time Frame: 15 years in average ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358421


Contacts
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Contact: Vicente Montañana-Ramírez, MD, PhD +34 961 245 841 monti8121@yahoo.com

Locations
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Spain
La Fe University Hospital Recruiting
Valencia, Spain, 46026
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         
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
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Principal Investigator: Vicente Montañana-Ramirez, MD, PhD Instituto de Investigaciones Sanitarias La Fe

Additional Information:

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Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT02358421    
Other Study ID Numbers: Highresponse_ART
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: February 9, 2015
Last Verified: January 2015
Keywords provided by Instituto de Investigacion Sanitaria La Fe:
Rotterdam's diagnostic criteria of PCOS
Risk of OHSS