Prospective Genetic Study in Patients With Ovarian Insufficiency

Premature Ovarian Failure Clinical Trial

Official title:

Prospective Genetic Study in Patients With Ovarian Insufficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03474120
• Other study ID #: Ovarian-Gene
• Status: Recruiting
• Start date: April 20, 2018
• Est. completion date: December 24, 2023

Study information

• Verified date: July 2020
• Source: The First Affiliated Hospital of Anhui Medical University
• Contact: Yiran Zhou, bachelor
• Phone: +86 13605690313
• Email: zhouyiran0309[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

genetic screening and etiological analysis was conducted on patients with ovarian insufficiency and decline in ovarian reserve. All patients were enrolled in the IVF-treated and non-IVF-treated groups, followed up for long-term treatment outcomes and genomic screening.

Description:

The cause of ovarian insufficiency and decline in ovarian reserve are not clear, but most researchers think the probable causes are mainly three aspects: chromosomal abnormalities, genetic factors and autoimmune diseases，But the majority of patients with normal chromosome karyotype analysis. The screening of pathogenic genes in patients with normal karyotype is the focus of current premature ovarian insufficiency(POI) and decline in ovarian reserve(DOR) etiology, to further explain the pathogenesis of patients, improve the diagnosis of those diseases and Clinical treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 24, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed as "premature ovarian insufficiency", "diminished ovarian reserve", "primary amenorrhea", " ovarian dysgenesis", " repeated implantation failure"

Exclusion Criteria:

• To rule out polycystic ovary syndrome(PCOS), iatrogenic factors (such as surgery, radiotherapy and chemotherapy, etc.) lead to premature ovarian insufficiency in patients

Related Conditions & MeSH terms

• Diminished Ovarian Reserve
• Menopause, Premature
• Ovarian Dysgenesis
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Procedure:
• IVF treatment
Relationship between IVF treatment outcome and genotypes in POI//DOR/ovarian dysgenesis patients

Locations

Country	Name	City	State
China	Reproductive Medicine Center, the First Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui Medical University	National Research Institute for Family Planning, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genotype	Measure the genotype by genome-wide sequencing of exomes(WES) in subjects.	1/4/2018-24/12/2020
Secondary	Dimensions of uterus	Measure the vertical diameter,transverse diameter and anteroposterior diameter of uterus in millimeters	1/4/2018-24/12/2020
Secondary	Antral follicle count	Measure the basic antral follicle count before controlled ovarian hyperstimulation.	1/4/2018-24/12/2020
Secondary	Endometrial thickness	Measure endometrial thickness of subjects in millimeters.	1/4/2018-24/12/2020
Secondary	Live birth rate	Record the live birth rate of offspring in in both groups.	1/4/2018-24/12/2020
Secondary	Neonatal weight	Record the neonatal weight(in kilogram) of offspring in two groups.	1/4/2018-24/12/2020