Premature Ovarian FailureNCT03474120
Prospective Genetic Study in Patients With Ovarian Insufficiency
An observational study of Premature Ovarian Failure and Primary Ovarian Insufficiency, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premature Ovarian Failure, Primary Ovarian Insufficiency, Ovarian Dysgenesis
- What is being tested?
- IVF treatment
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2018to 24 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Patients diagnosed as "premature ovarian insufficiency", "diminished ovarian reserve", "primary amenorrhea", " ovarian dysgenesis", " repeated implantation failure"
Who cannot join
- To rule out polycystic ovary syndrome（PCOS）, iatrogenic factors (such as surgery, radiotherapy and chemotherapy, etc.) lead to premature ovarian insufficiency in patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive Medicine Center, the First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230032
Yiran Zhou, MD, +8613605690313, zhouyiran0309@163.com
Bingbing Wang, Ph.D, +13552883407, wbbahu@163.com
About this study
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.
- Conditions
- Premature Ovarian Failure, Primary Ovarian Insufficiency, Ovarian Dysgenesis, Diminished Ovarian Reserve
- Being tested
- IVF treatment
- Keywords
- Genetic causes, etiology, POI, DOR
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVF treatmentProcedure or surgery
Also called No IVF treatment
Relationship between IVF treatment outcome and genotypes in POI//DOR/ovarian dysgenesis patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype
Measure the genotype by genome-wide sequencing of exomes(WES) in subjects.
Measured: 1/4/2018-24/12/2020
Secondary outcomes (5)
Dimensions of uterus
Measure the vertical diameter，transverse diameter and anteroposterior diameter of uterus in millimeters
Measured: 1/4/2018-24/12/2020
Antral follicle count
Measure the basic antral follicle count before controlled ovarian hyperstimulation.
Measured: 1/4/2018-24/12/2020
Endometrial thickness
Measure endometrial thickness of subjects in millimeters.
Measured: 1/4/2018-24/12/2020
Live birth rate
Record the live birth rate of offspring in in both groups.
Measured: 1/4/2018-24/12/2020
Neonatal weight
Record the neonatal weight(in kilogram) of offspring in two groups.
Measured: 1/4/2018-24/12/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start20 Apr 2018
- Primary completion24 Jan 2023 (estimated)
- Study completion24 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Institute for Family Planning, China
- Responsible party
- Sponsor
- Investigators
- Yunxia Cao, PhD, Study director, Reproductive Medicine Center, the First Affiliated Hospital of AMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474120
- Sponsor's protocol ID
- Ovarian-Gene
- Status last verified
- Jul 2020
- First submitted
- 5 Feb 2018
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Genetic Study in Patients With Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT03474120
- Acronym / sponsor ID
- Ovarian-Gene
- Conditions
- Premature Ovarian Failure, Primary Ovarian Insufficiency, Ovarian Dysgenesis, Diminished Ovarian Reserve
- Keywords
- Genetic causes, etiology, POI, DOR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- National Research Institute for Family Planning, China
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 24 Jan 2023 (estimated)
- Study completion
- 24 Dec 2023 (estimated)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF treatment group | – | Procedure: IVF treatmentPatients 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients diagnosed as "premature ovarian insufficiency", "diminished ovarian reserve", "primary amenorrhea", " ovarian dysgenesis", " repeated implantation failure"
Key exclusion criteria (1 listed)
- To rule out polycystic ovary syndrome（PCOS）, iatrogenic factors (such as surgery, radiotherapy and chemotherapy, etc.) lead to premature ovarian insufficiency in patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVF treatmentAlso: No IVF treatmentRelationship between IVF treatment outcome and genotypes in POI//DOR/ovarian dysgenesis patients | Procedure or surgery | IVF treatment group |
Primary outcome
Genotype
Time frame: 1/4/2018-24/12/2020
Measure the genotype by genome-wide sequencing of exomes(WES) in subjects.
5 secondary outcomes
Dimensions of uterus
Time frame: 1/4/2018-24/12/2020
Antral follicle count
Time frame: 1/4/2018-24/12/2020
Endometrial thickness
Time frame: 1/4/2018-24/12/2020
Live birth rate
Time frame: 1/4/2018-24/12/2020
Neonatal weight
Time frame: 1/4/2018-24/12/2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunxia Cao, PhD study director
Reproductive Medicine Center, the First Affiliated Hospital of AMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ovarian Failure and Primary Ovarian Insufficiency, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiran Zhou, bachelor (+86 13605690313, zhouyiran0309@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotype (time frame: 1/4/2018-24/12/2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.