Observational Epidemiologic Study in Women With Premature Ovarian Failure (POF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT02068976
First received: February 17, 2014
Last updated: September 14, 2015
Last verified: September 2015
  Purpose
This is an observational epidemiologic multicentric study of follow-up a cohort for described the situation of patients with primary ovarian insufficiency in public population with respect to the age of apparition the primary ovarian insufficiency .

Condition
Primary Ovarian Insufficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Epidemiologic Study in Women With Premature Ovarian Failure (POF)

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Age [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Age when diagnosed primary ovarian insufficiency


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women with Primary Ovarian Insufficiency

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients procedints of gynecology deparment of the centers participants
Criteria

Inclusion criteria:

  • Women between 18 years and 39 years.
  • Primary ovarian insufficiency demonstrated with amenorrhea and levels of follicle stimulating hormone (FSH) over to 40 IU in two determinations measured with a difference of one moth.
  • Not present linguistic barriers ,shaw attitude towards collaboration ,be able to attend the study center for all follow-up visits.
  • Signed informed consent before inclusion in the study and after having been informed of the procedures performed in this study.

Exclusion criteria :

  • Women with secondary hormonal alteration that do no meet the diagnostic criteria of the disease.
  • Refusal to participate.
  • Withdrawal of informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068976

Contacts
Contact: Misericordia Guinot, MD PhD +34935537041 mguinot@santpau.cat

Locations
Spain
Hospital de Manacor Recruiting
Manacor, Palma de Mallorca, Spain
Contact: Calvo Pérez, MD         
Principal Investigator: Calvo Pérez, MD         
Hospital Universitario Central de Asturias Recruiting
Asturias, Spain
Contact: Placido Llaneza, MD         
Principal Investigator: Placido Llaneza, MD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Misericordia Guinot, MD PhD    +935537041    mguinot@santpau.cat   
Hospital Terrasa Recruiting
Barcelona, Spain
Contact: Beatriz Roca, MD         
Principal Investigator: Beatriz Roca, MD         
Hospital Universitari Mutua de Terrasa Recruiting
Barcelona, Spain
Contact: Jordi Tomas, MD         
Principal Investigator: Jordi Tomas, MD         
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain
Contact: Jorge Fernandez, MD         
Principal Investigator: Jorge Fernandez, MD         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Study Chair: Misericordia Guinot, MD PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02068976     History of Changes
Other Study ID Numbers: IIBSP-IOP-2012-109 
Study First Received: February 17, 2014
Last Updated: September 14, 2015
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Primary Ovarian Insufficiency
Gonadal Dysgenesis
Turner Syndrome
Menopause, Premature
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 21, 2016