Primary Ovarian InsufficiencyNCT03518918
Establishing the Diagnosis Standard and Analysis the Risk Factors of POI in Chinese Women
An observational study of Primary Ovarian Insufficiency, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women. Read more about this study
- Who is it for?
- Ages 12 to 39 years, women only
- Conditions the study is for
- Primary Ovarian Insufficiency
- How many people
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2016to 1 Dec 2021
- 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 12 to 39 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Female under the condition of diminished ovarian reserve were enrolled in the study. The condition of diminished ovarian reserve may be the early stage of premature ovarian insufficiency.
Who may be able to join
- Infertility
- The length of menstrual cycle longer than 35 days or shorter than/amenorrhea
- Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤7, on at least two occasion >4 weeks apart
Who cannot join
- Polycystic Ovarian Syndrome
- other causes of amenorrhea
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
Shi-Ling Chen, M.D., Ph.D., +86-20-62787604, chensl_92@163.com
Shi-Ling Chen, M.D., Ph.D.
About this study
Official title: Establishing the Diagnosis Standard and Analysis the Risk Factors of Premature Ovarian Insufficiency in Chinese Women： Multi-center, Prospective,Observational Study
The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.
Read the detailed description
Premature ovarian insufficiency (POI) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. The POI guideline development group of ESHRE recommends the following diagnostic criteria: oligo/amenorrhea for at least 4 months and an elevated follicle stimulating hormone (FSH) level >25 mIU/mL on two occasion >4 weeks apart. But there still no diagnosis standard of POI in Chinese.The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.
- Conditions
- Primary Ovarian Insufficiency
- Keywords
- Premature ovarian insufficiency, Diagnosis standard, Risk factors
- Medical subject headings
- Primary Ovarian Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum FSH levels
the serum FSH levels between day 2 to day 5 of menstrual cycle from date of recruit until the date of study completion or date of twice FSH level >25mIU/mL, whichever came first.
Measured: through study completion, an average of 3 months, assessed up to 48 months
Menstruation situation
the length of the menstrual cycle from date of recruit until the date of study completion or date of twice FSH level >25mIU/mL, whichever came first.
Measured: through study completion, an average of 3 months, assessed up to 48 months
Secondary outcomes (2)
Change of Antral follicle count
the Antral follicle count between day 2 to day 5 of menstrual cycle from date of recruit until the date of study completion or date of twice FSH level >25mIU/mL, whichever came first.
Measured: through study completion, an average of 3 months, assessed up to 48 months
Change of anti-mullerian hormone levels
the anti-mullerian hormone between day 2 to day 5 of menstrual cycle from date of recruit until the date of study completion or date of twice FSH level >25mIU/mL, whichever came first.
Measured: through study completion, an average of 3 months, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start1 Sep 2016
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies 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
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Southern Medical University, China, The Third Affiliated Hospital of Southern Medical University, Shenzhen Hospital of Southern Medical University, Shen-Zhen City Maternity and Child Healthcare Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Shi-ling Chen, M.D, Ph.D, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518918
- Sponsor's protocol ID
- NFEC-2016-141
- Status last verified
- May 2017
- First submitted
- 13 Jun 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Diagnosis Standard and Analysis the Risk Factors of Premature Ovarian Insufficiency in Chinese Women： Multi-center, Prospective,Observational Study
- ClinicalTrials.gov ID
- NCT03518918
- Acronym / sponsor ID
- NFEC-2016-141
- Conditions
- Primary Ovarian Insufficiency
- Keywords
- Premature ovarian insufficiency, Diagnosis standard, Risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Southern Medical University, China, The Third Affiliated Hospital of Southern Medical University, Shenzhen Hospital of Southern Medical University, Shen-Zhen City Maternity and Child Healthcare Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 8 May 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.
The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.
Detailed description
Premature ovarian insufficiency (POI) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. The POI guideline development group of ESHRE recommends the following diagnostic criteria: oligo/amenorrhea for at least 4 months and an elevated follicle stimulating hormone (FSH) level >25 mIU/mL on two occasion >4 weeks apart. But there still no diagnosis standard of POI in Chinese.The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Female under the condition of diminished ovarian reserve were enrolled in the study. The condition of diminished ovarian reserve may be the early stage of premature ovarian insufficiency.
Key inclusion criteria (3 listed)
- Infertility
- The length of menstrual cycle longer than 35 days or shorter than/amenorrhea
- Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤7, on at least two occasion >4 weeks apart
Key exclusion criteria (2 listed)
- Polycystic Ovarian Syndrome
- other causes of amenorrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of serum FSH levels
Time frame: through study completion, an average of 3 months, assessed up to 48 months
the serum FSH levels between day 2 to day 5 of menstrual cycle from date of recruit until the date of study completion or date of twice FSH level >25mIU/mL, whichever came first.
Menstruation situation
Time frame: through study completion, an average of 3 months, assessed up to 48 months
the length of the menstrual cycle from date of recruit until the date of study completion or date of twice FSH level >25mIU/mL, whichever came first.
2 secondary outcomes
Change of Antral follicle count
Time frame: through study completion, an average of 3 months, assessed up to 48 months
Change of anti-mullerian hormone levels
Time frame: through study completion, an average of 3 months, assessed up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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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 chair
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 Primary Ovarian Insufficiency, 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 3 inclusion and 2 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 8 May 2018. 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?
Change of serum FSH levels (time frame: through study completion, an average of 3 months, assessed up to 48 months). The study lists 2 primary outcomes in all. 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 8 May 2018.