Clinical trial NCT02068976: Observational Epidemiologic Study in Women With Premature Ovarian Failure (POF)
Official title: Observational Epidemiologic Study in Women With Premature Ovarian Failure (POF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Ovarian Insufficiency
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients procedints of gynecology deparment of the centers participants

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Age
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Sant Cugat Del Vallès
country: Spain
facility: Hospital Universitari General de Catalunya
state: Barcelona
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Materno Infantil de Canarias
state: Las Palmas
city: Manacor
country: Spain
facility: Hospital de Manacor
state: Palma De Mallorca
city: Almería
country: Spain
facility: Hospital de Poniente de El Egido
city: Avila
country: Spain
facility: Complejo Asistencial de Avila
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Terrasa
city: Barcelona
country: Spain
facility: Hospital Universitari Mutua de Terrasa
city: Bilbao
country: Spain
facility: Hospital Universitario de Cruces
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Granada
country: Spain
facility: Universidad de Granada
city: Lleida
country: Spain
facility: Grupo Hospitalario Perpetuo Socorro
city: Murcia
country: Spain
facility: HCU Virgen de la Arrixaca
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Misericordia Guinot, MD PhD
role: STUDY_CHAIR
References: