Development a Predictive Nomogram for Primary Ovarian Insufficiency

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

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China, 510000
      • Guangdong provicial hospital of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Primary Ovarian insufficiency group; 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; 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

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ANTICIPATED): May 1, 2018
• Study Completion (ANTICIPATED): July 1, 2018

Study Registration Dates

• First Submitted: March 19, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (ESTIMATE): June 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Primary Ovarian Insufficiency; nomogram
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: 2014KT1165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED