Diminished Ovarian ReserveNCT04711772
Whole-genome Sequencing Study in Patients With Diminished Ovarian Reserve
An observational study of Diminished Ovarian Reserve, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The study aims to explore the genetic pathogenesis of diminished ovarian reserve via whole-genome sequencing technology in Chinese women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve
- What is being tested?
- whole-genome sequencing
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Dec 2022
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The two groups of this study consist of DOR patients and women with normal ovarian reserve.
Who may be able to join
- DOR group:
- age between 18 and 40 years;
- number of oocytes obtained in previous ovarian stimulation cycles ≤3;
- bilateral ovarian antral follicle count (AFC) < 5-7;
- serum anti-Mullerian hormone (AMH) <0.5-1.1ng/ml.
- Control group:
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- age between 18 and 40 years;
- bilateral AFC ≥8;
- serum AMH ≥1.2ng/ml;
- regular menstrual cycles occurring every 25-35 days.
Who cannot join
- The exclusion criteria of the two groups were:
- an abnormal karyotype;
- a history of other endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia and hyperthyroidism;
- a history of radiotherapy, chemotherapy and ovarian surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Chen Shi-Ling, M.D., Ph.D, +86-20-62787604, chensl_92@163.com
Chen Shi-Ling, M.D., Ph.D
About this study
Official title: A Whole-genome Sequencing Base Study on Genetic Pathogenesis of Diminished Ovarian Reserve
The study aims to explore the genetic pathogenesis of diminished ovarian reserve via whole-genome sequencing technology in Chinese women.
Read the detailed description
Diminished ovarian reserve (DOR), a pathological condition of reduced quantity and quality of oocytes, has severe impairment on women fertility. Some women experience DOR may develop into premature ovarian insufficiency (POI), which defined as a cessation of function of ovaries in women younger than 40 years old. The pathogenesis of DOR is multiple and the etiology of most DOR remains obscure. Genetic factors, including chromosome abnormality, genetic variation, and non-coding RNA abnormal regulation are considered the major mechanisms of DOR. More than 12 gene mutations, detected by whole-exome sequencing (WES), have been implicated as potential causes of DOR. However, we have found that coding gene mutation detected by WES may only account for a small part of DOR. Whole-genome sequencing (WGS) has been developing into an important strategy for identifying exons, introns and mitochondrial DNA mutation. However, the application of WGS is still lacking in detecting pathogenic genes of DOR. Therefore, this study intends to explore the possible pathogenic genes by WGS in order to deeply and comprehensively understand the pathogenic mechanism of DOR.
- Conditions
- Diminished Ovarian Reserve
- Being tested
- whole-genome sequencing
- Keywords
- Diminished Ovarian Reserve, Whole-genome Sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole-genome sequencingOther
Whole-genome sequencing will be preformed for each participate to explore the potential disease-causing genes of DOR.
| Study group | Role | What they receive |
|---|---|---|
| DOR group | Genomic DNA will be extracted from peripheral blood leukocytes to perform whole-genome sequencing in participates with diminished ovarian reserve. Receives: Other: whole-genome sequencing | |
| Control group | Participants with normal ovarian reserve will be recruited as control group and peripheral blood leukocytes genomic DNA will be extracted to perform whole-genome sequencing. Receives: Other: whole-genome sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype
Measure the genotype by whole-genome sequencing in all participates.
Measured: 1/9/2020-31/12/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Sep 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Shi-ling Chen, M.D, Ph.D, Study director, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711772
- Sponsor's protocol ID
- NFEC-2020-188
- Status last verified
- May 2020
- First submitted
- 13 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Whole-genome Sequencing Base Study on Genetic Pathogenesis of Diminished Ovarian Reserve
- ClinicalTrials.gov ID
- NCT04711772
- Acronym / sponsor ID
- NFEC-2020-188
- Conditions
- Diminished Ovarian Reserve
- Keywords
- Diminished Ovarian Reserve, Whole-genome Sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Jan 2021 (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.
The study aims to explore the genetic pathogenesis of diminished ovarian reserve via whole-genome sequencing technology in Chinese women.
Detailed description
Diminished ovarian reserve (DOR), a pathological condition of reduced quantity and quality of oocytes, has severe impairment on women fertility. Some women experience DOR may develop into premature ovarian insufficiency (POI), which defined as a cessation of function of ovaries in women younger than 40 years old. The pathogenesis of DOR is multiple and the etiology of most DOR remains obscure. Genetic factors, including chromosome abnormality, genetic variation, and non-coding RNA abnormal regulation are considered the major mechanisms of DOR. More than 12 gene mutations, detected by whole-exome sequencing (WES), have been implicated as potential causes of DOR. However, we have found that coding gene mutation detected by WES may only account for a small part of DOR. Whole-genome sequencing (WGS) has been developing into an important strategy for identifying exons, introns and mitochondrial DNA mutation. However, the application of WGS is still lacking in detecting pathogenic genes of DOR. Therefore, this study intends to explore the possible pathogenic genes by WGS in order to deeply and comprehensively understand the pathogenic mechanism of DOR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DOR group | – | Other: whole-genome sequencingGenomic DNA will be extracted from peripheral blood leukocytes to perform whole-genome sequencing in participates with diminished ovarian reserve. |
| Control group | – | Other: whole-genome sequencingParticipants with normal ovarian reserve will be recruited as control group and peripheral blood leukocytes genomic DNA will be extracted to perform whole-genome sequencing. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The two groups of this study consist of DOR patients and women with normal ovarian reserve.
Key inclusion criteria (10 listed)
- age between 18 and 40 years;
- number of oocytes obtained in previous ovarian stimulation cycles ≤3;
- bilateral ovarian antral follicle count (AFC) < 5-7;
- serum anti-Mullerian hormone (AMH) <0.5-1.1ng/ml.
- age between 18 and 40 years;
Key exclusion criteria (4 listed)
- an abnormal karyotype;
- a history of other endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia and hyperthyroidism;
- a history of radiotherapy, chemotherapy and ovarian surgery.
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 |
|---|---|---|
| whole-genome sequencingWhole-genome sequencing will be preformed for each participate to explore the potential disease-causing genes of DOR. | Other | Control group, DOR group |
Primary outcome
Genotype
Time frame: 1/9/2020-31/12/2022
Measure the genotype by whole-genome sequencing in all participates.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Shi-ling Chen, M.D, Ph.D study director
Nanfang Hospital, Southern Medical University
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 Diminished Ovarian Reserve, run by Nanfang Hospital, Southern 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 10 inclusion and 4 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 15 Jan 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 Shi-ling Chen, M.D, Ph.D (+86-020-62787604, chensl_92@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: 1/9/2020-31/12/2022). 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 15 Jan 2021.