Development a Predictive Nomogram for Primary Ovarian Insufficiency

Primary Ovarian Insufficiency Clinical Trial

Official title:

Development a Predictive Nomogram for Primary Ovarian Insufficiency

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02795000
• Other study ID #: 2014KT1165
• Status: Active, not recruiting
• First received: March 19, 2016
• Last updated: April 9, 2018
• Start date: October 2016
• Est. completion date: July 2018

Study information

• Verified date: June 2016
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to develop a predictive nomogram for primary ovarian insufficiency.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: July 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• Age18--42

• Definite spontaneous last menstrual period

• Informed consent for participating this research and could answer the questionnaires faithfully.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Menopause, Premature
• Primary Ovarian Insufficiency
• Turner Syndrome

Locations

Country	Name	City	State
China	Guangdong provicial hospital of Chinese Medicine	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) .	1years
Secondary	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	2years