Observational Epidemiologic Study in Women With Premature... | NCT02068976

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

NCT02068976

Sponsor

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

Status

Unknown status

Last Update Posted

May 10, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Primary Ovarian Insufficiency

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 28, 2013Actual

Primary Completion Date

Jan 2024Estimated

Completion Date

Jun 2024Estimated

First Submitted Date

Feb 17, 2014

First Submission Date that Met QC Criteria

Feb 20, 2014

First Posted Date

Feb 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2022

Last Update Posted Date

May 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Women with Primary Ovarian Insufficiency

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Patients procedints of gynecology deparment of the centers participants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Misericordia Guinot, MD PhD	Contact	+34935537041		mguinot@santpau.cat

Overall Officials

Name	Affiliation	Role
Misericordia Guinot, MD PhD	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari General de Catalunya	Recruiting	Sant Cugat del Vallès	Barcelona		Spain

Condition Browse Module

MeSH Terms

ID	Term
D016649	Primary Ovarian Insufficiency

Ancestor Terms

ID	Term
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided