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Status unknownNCT03474120Updated Feb 21, 2021

Prospective Genetic Study in Patients With Ovarian Insufficiency

An observational study in Premature Ovarian Failure, Primary Ovarian Insufficiency and Ovarian Dysgenesis, sponsored by The First Affiliated Hospital of Anhui Medical University. Status unknown at 1 site in China. Open to female participants. Per ClinicalTrials.gov, last updated 2021-02-21.

Sponsored by The First Affiliated Hospital of Anhui Medical University · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

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

Keywords

  • Genetic causes
  • etiology
  • POI
  • DOR
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Procedure: IVF treatment

  • No IVF treatment group

    the patients who did not have received IVF treatment .Patients were followed up to collect hormone levels, ultrasound results.

Interventions

  • ProcedureIVF treatment

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

    Also known as: No IVF treatment

05

What researchers measure

Primary outcomes

  1. Genotype

    Measure the genotype by genome-wide sequencing of exomes(WES) in subjects.

    Time frame: 1/4/2018-24/12/2020

Secondary outcomes

  1. Dimensions of uterus

    Measure the vertical diameter,transverse diameter and anteroposterior diameter of uterus in millimeters

    Time frame: 1/4/2018-24/12/2020

  2. Antral follicle count

    Measure the basic antral follicle count before controlled ovarian hyperstimulation.

    Time frame: 1/4/2018-24/12/2020

  3. Endometrial thickness

    Measure endometrial thickness of subjects in millimeters.

    Time frame: 1/4/2018-24/12/2020

  4. Live birth rate

    Record the live birth rate of offspring in in both groups.

    Time frame: 1/4/2018-24/12/2020

  5. Neonatal weight

    Record the neonatal weight(in kilogram) of offspring in two groups.

    Time frame: 1/4/2018-24/12/2020

06

Study locations

1 of 1 sites recruiting
  • Reproductive Medicine Center, the First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui 230032, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03474120
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborators
National Research Institute for Family Planning, China
Responsible party
Sponsor
First posted
Mar 22, 2018
Start date
Apr 20, 2018
Primary completion
Jan 24, 2023 (estimated)
Completion
Dec 24, 2023 (estimated)
Last update
Feb 21, 2021

Study contacts

Yiran Zhou, bachelor
Contact
zhouyiran0309@163.com
+86 13605690313
Binbin Wang, PhD
Contact
wbbahu@163.com
+86 13552883407
Yunxia Cao, PhD
study director · Reproductive Medicine Center, the First Affiliated Hospital of AMU

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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