Primary Ovarian InsufficiencyNCT02068976
Observational Epidemiologic Study in Women With Premature Ovarian Failure (POF)
An observational study of Primary Ovarian Insufficiency, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 15 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Primary Ovarian Insufficiency
- How many people
- 100 participants
- Where
- 15 sitesSpain
- Study dates
- 28 Nov 2013to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients procedints of gynecology deparment of the centers participants
Who may be able to join
- 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.
Who cannot join
- Women with secondary hormonal alteration that do no meet the diagnostic criteria of the disease.
- Refusal to participate.
- Withdrawal of informed consent.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites, 14 recruiting
- Recruiting
Hospital de Poniente de El Egido
Almería
Pablo Romero, MD
- Recruiting
Complejo Asistencial de Avila
Ávila
Ana Castro, MD
Ana Castro, MD
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Misericordia Guinot, MD PhD, +935537041, mguinot@santpau.cat
- Recruiting
Hospital Terrasa
Barcelona
Beatriz Roca, MD
Beatriz Roca, MD
- Recruiting
Hospital Universitari Mutua de Terrasa
Barcelona
Jordi Tomas, MD
Jordi Tomas, MD
- Recruiting
Hospital Universitario de Cruces
Bilbao
Borja O Garcia Ramos, MD
Borja O Garcia Ramos, MD
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada
Jorge Fernandez, MD
Jorge Fernandez, MD
- Recruiting
Universidad de Granada
Granada
Nicolas Mendoza Ladron de Guevara, MD
Nicolas Mendoza Ladron de Guevara, MD
- Recruiting
Hospital Universitario Materno Infantil de Canarias
Las Palmas de Gran Canaria, Las Palmas
Patricia Escamilla, MD
- Recruiting
Grupo Hospitalario Perpetuo Socorro
Lleida
Marta Canals, MD
Marta Canals, MD
- Suspended
Hospital de Manacor
Manacor, Palma de Mallorca
- Recruiting
HCU Virgen de la Arrixaca
Murcia
Isabel Ñiguez, MD
Isabel Ñiguez, MD
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias
Placido Llaneza, MD
Placido Llaneza, MD
- Recruiting
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona
Sonia Sánchez, MD
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza
Laura Baquedano, MD
About this study
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.
- Conditions
- Primary Ovarian Insufficiency
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with Primary Ovarian Insufficiency | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age when diagnosed primary ovarian insufficiency
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study start28 Nov 2013
- Primary completionJan 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misericordia Guinot, MD PhD, Study chair, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068976
- Sponsor's protocol ID
- IIBSP-IOP-2012-109
- Status last verified
- May 2022
- First submitted
- 17 Feb 2014
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Epidemiologic Study in Women With Premature Ovarian Failure (POF)
- ClinicalTrials.gov ID
- NCT02068976
- Acronym / sponsor ID
- IIBSP-IOP-2012-109
- Conditions
- Primary Ovarian Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 28 Nov 2013 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with Primary Ovarian Insufficiency | – | – |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients procedints of gynecology deparment of the centers participants
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Women with secondary hormonal alteration that do no meet the diagnostic criteria of the disease.
- Refusal to participate.
- Withdrawal of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age
Time frame: Day 0
Age when diagnosed primary ovarian insufficiency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misericordia Guinot, MD PhD study chair
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Ovarian Insufficiency, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Misericordia Guinot, MD PhD (+34935537041, mguinot@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.