Primary Ovarian InsufficiencyNCT02795000
Development a Predictive Nomogram for Primary Ovarian Insufficiency
An observational study of Primary Ovarian Insufficiency, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this research is to develop a predictive nomogram for primary ovarian insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Ovarian Insufficiency
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Jul 2018
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population will be recruted from gynaecology department clinic of GuangDong provincial hospital of Chinese Medicine and web advertisement from April 2016 and December 2018.
Who may be able to join
- Age18--42
- Definite spontaneous last menstrual period
- Informed consent for participating this research and could answer the questionnaires faithfully.
Who cannot join
- Congenital gonadal dysgenesis and non organic diseases lead to menstrual disorders.
- Endocrine diseases such Polycystic ovary syndrome, hyperprolactinemia, dysfunctional uterine bleeding, low gonadotropin menstrual disorders and hyperthyreosis
- Reproductive toxicity of drugs used
- Release of chemotherapeutic drugs
- Accept sex hormone medicine in recent 3 months
- Pregnant and lactating women
- With serious heart, liver, kidney and other diseases
- With severe psychiatric disorders
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong provicial hospital of Chinese Medicine
Guangzhou, Guangdong, 510000
About this study
The purpose of this research is to develop a predictive nomogram for primary ovarian insufficiency.
Read the detailed description
Many researches show primary ovarian insufficiency(POI) etiology is related with gene,immunization,iatrogenic, infection factors and social factors etc. In fact, approximate 70-90% POI have no definite cause, so a lot of patients don't know what will happen when they in occult stage of POI. In this research, researchers will investigate all possible factors in POI patients and normal women and select the valuable risk factor by integrated by statistical method to establish the reasonable predictive model.
This study consists two stages.The fist stage is the model establishment, the second stage is the certificate and evaluate the model.
- Conditions
- Primary Ovarian Insufficiency
- Keywords
- Primary Ovarian Insufficiency, nomogram
- 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 |
|---|---|---|
| Primary Ovarian insufficiency group | 1. amenorrhea one year or more than one year 2. amenorrhea more than 4 months and FSH≥40IU/L 3. ≤42 years old and AMH≤0.071 | |
| The normal group | 1. normal regular menorrhea 2. ≤42 years old 3. normal FSH and AMH level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Draw the Primary Ovarian insufficiency normogram
Retrospective Investigation on inclusion criteria populations through multivariate cox proportional hazards regression analysis of independent risk factors can enter the predictive model using R software based on regression coefficient related variables draw the corresponding nomogram (nomogram) .
Measured: 1years
Secondary outcomes (1)
Verify and evaluate the evaluation of Primary Ovarian insufficiency normogram
using the bootstrap method nomogram for internal verification to reduce overfitting bias, the evaluation of the model to predict the risk of premature menopause conformity. In the study population data, select postmenopausal cases, the use of prediction of survival analysis model initial assessment model; select Not menopause an independent risk factor for the population were followed ovarian anti-Mullerian hormone (AMH) decreased the extent of menopause Age as a standard curve prediction, evaluation nomogram model predictive accuracy and clinical value of premature menopause, and finally provide the first Chinese people have the physical characteristics of premature menopause prediction model
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2018 (estimated)
- Study completionJul 2018 (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.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hongyan Yang, professor, Study chair, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795000
- Sponsor's protocol ID
- 2014KT1165
- Status last verified
- Jun 2016
- First submitted
- 19 Mar 2016
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development a Predictive Nomogram for Primary Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT02795000
- Acronym / sponsor ID
- 2014KT1165
- Conditions
- Primary Ovarian Insufficiency
- Keywords
- Primary Ovarian Insufficiency, nomogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 9 Jun 2016 (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.
The purpose of this research is to develop a predictive nomogram for primary ovarian insufficiency.
Detailed description
Many researches show primary ovarian insufficiency(POI) etiology is related with gene,immunization,iatrogenic, infection factors and social factors etc. In fact, approximate 70-90% POI have no definite cause, so a lot of patients don't know what will happen when they in occult stage of POI. In this research, researchers will investigate all possible factors in POI patients and normal women and select the valuable risk factor by integrated by statistical method to establish the reasonable predictive model.
This study consists two stages.The fist stage is the model establishment, the second stage is the certificate and evaluate the model.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Ovarian insufficiency group | – | –1. amenorrhea one year or more than one year 2. amenorrhea more than 4 months and FSH≥40IU/L 3. ≤42 years old and AMH≤0.071 |
| The normal group | – | –1. normal regular menorrhea 2. ≤42 years old 3. normal FSH and AMH level |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be recruted from gynaecology department clinic of GuangDong provincial hospital of Chinese Medicine and web advertisement from April 2016 and December 2018.
Key inclusion criteria (3 listed)
- Age18--42
- Definite spontaneous last menstrual period
- Informed consent for participating this research and could answer the questionnaires faithfully.
Key exclusion criteria (8 listed)
- Congenital gonadal dysgenesis and non organic diseases lead to menstrual disorders.
- Endocrine diseases such Polycystic ovary syndrome, hyperprolactinemia, dysfunctional uterine bleeding, low gonadotropin menstrual disorders and hyperthyreosis
- Reproductive toxicity of drugs used
- Release of chemotherapeutic drugs
- Accept sex hormone medicine in recent 3 months
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
Draw the Primary Ovarian insufficiency normogram
Time frame: 1years
Retrospective Investigation on inclusion criteria populations through multivariate cox proportional hazards regression analysis of independent risk factors can enter the predictive model using R software based on regression coefficient related variables draw the corresponding nomogram (nomogram) .
1 secondary outcome
Verify and evaluate the evaluation of Primary Ovarian insufficiency normogram
Time frame: 2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
hongyan Yang, professor study chair
Guangzhou University of Traditional Chinese Medicine
1 site 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 Guangzhou University of Traditional Chinese Medicine at 1 site in China.
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 3 inclusion and 8 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 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Draw the Primary Ovarian insufficiency normogram (time frame: 1years). 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 Apr 2018.