Development a Predictive Nomogram for Primary Ovarian Insufficiency

NCT ID: NCT02795000

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-07-31

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.

Conditions

Primary Ovarian Insufficiency

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this group

The normal group

1. normal regular menorrhea

2. ≤42 years old

3. normal FSH and AMH level

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

hongyan Yang, professor

Role: STUDY_CHAIR

Guangzhou University of Traditional Chinese Medicine

Locations

Guangdong provicial hospital of Chinese Medicine

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2014KT1165

Identifier Type: -

Identifier Source: org_study_id