Prospective Genetic Study in Patients With Ovarian Insufficiency
1 other identifier
observational
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2018
CompletedFirst Posted
Study publicly available on registry
March 22, 2018
CompletedStudy Start
First participant enrolled
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 24, 2023
CompletedFebruary 21, 2021
July 1, 2020
4.8 years
February 5, 2018
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Genotype
Measure the genotype by genome-wide sequencing of exomes(WES) in subjects.
1/4/2018-24/12/2020
Secondary Outcomes (5)
Dimensions of uterus
1/4/2018-24/12/2020
Antral follicle count
1/4/2018-24/12/2020
Endometrial thickness
1/4/2018-24/12/2020
Live birth rate
1/4/2018-24/12/2020
Neonatal weight
1/4/2018-24/12/2020
Study Arms (2)
IVF treatment group
Patients treated with IVF. IVF promotion process, ovulation, fertilization, embryo quality, transplantation and final outcome were collected after the treatment cycle was completed.
No IVF treatment group
the patients who did not have received IVF treatment .Patients were followed up to collect hormone levels, ultrasound results.
Interventions
Relationship between IVF treatment outcome and genotypes in POI//DOR/ovarian dysgenesis patients
Eligibility Criteria
Patients who come to the First Affiliated Hospital of Anhui Medical University Reproductive Center and diagnosed as "premature ovarian insufficiency", "diminished ovarian reserve", "primary amenorrhea", " ovarian dysgenesis", " repeated implantation failure"，Understand the content of the project and sign an informed consent form
You may qualify if:
- Patients diagnosed as "premature ovarian insufficiency", "diminished ovarian reserve", "primary amenorrhea", " ovarian dysgenesis", " repeated implantation failure"
You may not qualify if:
- To rule out polycystic ovary syndrome（PCOS）, iatrogenic factors (such as surgery, radiotherapy and chemotherapy, etc.) lead to premature ovarian insufficiency in patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reproductive Medicine Center, the First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230032, China
Biospecimen
Collect 5 ml whole blood(in EDTA anticoagulant tube) and sign an informed consent form for patients diagnosed with POI/DOR/ovarian dysgenesis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yunxia Cao, PhD
Reproductive Medicine Center, the First Affiliated Hospital of AMU
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2018
First Posted
March 22, 2018
Study Start
April 20, 2018
Primary Completion
January 24, 2023
Study Completion
December 24, 2023
Last Updated
February 21, 2021
Record last verified: 2020-07