Development a Predictive Nomogram for Primary Ovarian Insufficiency

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Development a Predictive Nomogram for Primary Ovarian Insufficiency

Conditions
-----------------
Primary Ovarian Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Ovarian insufficiency group<br>amenorrhea one year or more than one year amenorrhea more than 4 months and FSH≥40IU/L ≤42 years old and AMH≤0.071 | |
| The normal group<br>normal regular menorrhea ≤42 years old normal FSH and AMH level | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Ovarian Insufficiency, nomogram