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NCT02068976 Clinical Trial

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

Primary Ovarian Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02068976
Other study ID # IIBSP-IOP-2012-109
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 28, 2013
Est. completion date June 2024

Study information
Verified date May 2022
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact Misericordia Guinot, MD PhD
Phone +34935537041
Email mguinot@santpau.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Hospital de Poniente de El Egido Almería
Spain Complejo Asistencial de Avila Avila
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital Terrasa Barcelona
Spain Hospital Universitari Mutua de Terrasa Barcelona
Spain Hospital Universitario de Cruces Bilbao
Spain Hospital Universitario Virgen de las Nieves Granada
Spain Universidad de Granada Granada
Spain Hospital Universitario Materno Infantil de Canarias Las Palmas De Gran Canaria Las Palmas
Spain Grupo Hospitalario Perpetuo Socorro Lleida
Spain Hospital de Manacor Manacor Palma De Mallorca
Spain HCU Virgen de la Arrixaca Murcia
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Hospital Universitari General de Catalunya Sant Cugat Del Vallès Barcelona
Spain Hospital Universitario Miguel Servet Zaragoza

Sponsors (1)
Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Age Age when diagnosed primary ovarian insufficiency Day 0
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