Development a Predictive Nomogram for Primary Ovarian Insufficiency

NCT02795000 | Unknown DMC

• 1 other identifier: 2014KT1165
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Ovarian Insufficiency

Keywords

Primary Ovarian Insufficiency; nomogram

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Verify and evaluate the evaluation of Primary Ovarian insufficiency normogram

  2years

Study Arms (2)

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

The normal group

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

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Age18--42
• Definite spontaneous last menstrual period
• Informed consent for participating this research and could answer the questionnaires faithfully.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong provicial hospital of Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood to be retained

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• hongyan Yang, professor

  Guangzhou University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2016
• First Posted: June 9, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 10, 2018

Record last verified: 2016-06

Locations

CN (1)