NCT02068976

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

10.1 years

First QC Date

February 17, 2014

Last Update Submit

May 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Age

    Age when diagnosed primary ovarian insufficiency

    Day 0

Study Arms (1)

Women with Primary Ovarian Insufficiency

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients procedints of gynecology deparment of the centers participants

You may qualify if:

  • 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.

You may not qualify if:

  • Women with secondary hormonal alteration that do no meet the diagnostic criteria of the disease.
  • Refusal to participate.
  • Withdrawal of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

RECRUITING

Hospital Universitario Materno Infantil de Canarias

Las Palmas de Gran Canaria, Las Palmas, Spain

RECRUITING

Hospital de Manacor

Manacor, Palma de Mallorca, Spain

SUSPENDED

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

RECRUITING

Hospital de Poniente de El Egido

Almería, Spain

RECRUITING

Complejo Asistencial de Avila

Ávila, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Terrasa

Barcelona, Spain

RECRUITING

Hospital Universitari Mutua de Terrasa

Barcelona, Spain

RECRUITING

Hospital Universitario de Cruces

Bilbao, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Spain

RECRUITING

Universidad de Granada

Granada, Spain

RECRUITING

Grupo Hospitalario Perpetuo Socorro

Lleida, Spain

RECRUITING

HCU Virgen de la Arrixaca

Murcia, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Spain

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Misericordia Guinot, MD PhD

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    STUDY CHAIR

Central Study Contacts

Misericordia Guinot, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 21, 2014

Study Start

November 28, 2013

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations