Development a Predictive Nomogram for Primary Ovarian Insufficiency

Guangzhou University of Traditional Chinese Medicine

Status: Unknown

Conditions: Primary Ovarian Insufficiency

Study type: Observational

Funder types: Other

Identifiers

NCT02795000

2014KT1165

Details and patient eligibility

About

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

Full 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.

Enrollment: 260 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

260 participants in 2 patient groups

Primary Ovarian insufficiency group

Description:

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

Description:

1. normal regular menorrhea 2. ≤42 years old 3. normal FSH and AMH level