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

May 4, 2022 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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 .

iPOI (Investigators in premature ovarian insufficiency): M. Guinot, B. Roca, J. Tomás, P. Escamilla, J. Hernández, P. Llaneza, N. Mendoza Ladrón de Guevara, B. Otero García, I. Ñiguez, A. Castro, L. Baquedano, P. Romero, S. Sánchez.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Almería, Spain
        • Recruiting
        • Hospital de Poniente de El Egido
        • Contact:
          • Pablo Romero, MD
      • Avila, Spain
        • Recruiting
        • Complejo Asistencial de Ávila
        • Contact:
          • Ana Castro, MD
        • Principal Investigator:
          • Ana Castro, MD
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
      • Barcelona, Spain
        • Recruiting
        • Hospital Terrasa
        • Contact:
          • Beatriz Roca, MD
        • Principal Investigator:
          • Beatriz Roca, MD
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Mutua de Terrasa
        • Contact:
          • Jordi Tomas, MD
        • Principal Investigator:
          • Jordi Tomas, MD
      • Bilbao, Spain
        • Recruiting
        • Hospital Universitario de Cruces
        • Contact:
          • Borja O Garcia Ramos, MD
        • Principal Investigator:
          • Borja O Garcia Ramos, MD
      • Granada, Spain
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
          • Jorge Fernandez, MD
        • Principal Investigator:
          • Jorge Fernandez, MD
      • Granada, Spain
        • Recruiting
        • Universidad de Granada
        • Contact:
          • Nicolas Mendoza Ladron de Guevara, MD
        • Principal Investigator:
          • Nicolas Mendoza Ladron de Guevara, MD
      • Lleida, Spain
        • Recruiting
        • Grupo Hospitalario Perpetuo Socorro
        • Contact:
          • Marta Canals, MD
        • Principal Investigator:
          • Marta Canals, MD
      • Murcia, Spain
        • Recruiting
        • HCU Virgen de la Arrixaca
        • Contact:
          • Isabel Ñiguez, MD
        • Principal Investigator:
          • Isabel Ñiguez, MD
      • Zaragoza, Spain
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
          • Laura Baquedano, MD
    • Asturias
      • Oviedo, Asturias, Spain
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Placido Llaneza, MD
        • Principal Investigator:
          • Placido Llaneza, MD
    • Barcelona
      • Sant Cugat Del Vallès, Barcelona, Spain
        • Recruiting
        • Hospital Universitari General de Catalunya
        • Contact:
          • Sonia Sánchez, MD
    • Las Palmas
      • Las Palmas De Gran Canaria, Las Palmas, Spain
        • Recruiting
        • Hospital Universitario Materno Infantil de Canarias
        • Contact:
          • Patricia Escamilla, MD
    • Palma De Mallorca
      • Manacor, Palma De Mallorca, Spain
        • Suspended
        • Hospital de Manacor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 procedints of gynecology deparment of the centers participants

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Women with Primary Ovarian Insufficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Day 0
Age when diagnosed primary ovarian insufficiency
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 28, 2013

Primary Completion (ANTICIPATED)

January 1, 2024

Study Completion (ANTICIPATED)

June 1, 2024

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (ESTIMATE)

February 21, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-IOP-2012-109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Ovarian Insufficiency

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe