Female Infertility Due to Diminished Ovarian ReserveNCT02294500
Cohort Study to Evaluate Ovarian Function
An observational study of Female Infertility Due to Diminished Ovarian Reserve and Menopausal Syndrome, run by Shixuan Wang at 1 site in China.
Trial summary
The study will collect the clinical and biological data of the patients, the investigators could further analyse and identify the risk factors and optimize clinical treatment method. Besides, population-based healthy people with informed consent are also collected. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility Due to Diminished Ovarian Reserve, Menopausal Syndrome, Sexual Function and Fertility Disorders
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Jul 2021
- How long will I take part?
- 10 Years
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women with normal ovarian function or decreased ovarian function
Who may be able to join
- Karnofsky Performance Statue ≥ 70,
- WBC > 3,000/mm³,
- Hb > 9.0g/dl,
- Platelet > 100,000 /mm³,
- SGOT/SGPT < 60 IU/L,
- T-Bil < 1.5 mg/dL,
Show all 10Show fewer
- Cr < 1.2 mg/dL,
- PaO2 > 80 torr,
- normal ECG,
- Written informed consent.
Who cannot join
- Patients without information,
- clinical risk factors,
- Patients who have active infection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Shixuan Wang, MD. PhD., 86-27-8366-3078, sxwang2012@hotmail.com
Kecheng Huang, MD
About this study
Official title: Multicenter Cohort Study to Evaluate and to Protect Ovarian Function and Reproductive Function
The study will collect the clinical and biological data of the patients, the investigators could further analyse and identify the risk factors and optimize clinical treatment method. Besides, population-based healthy people with informed consent are also collected.
Read the detailed description
Menopause is the last step in the process of ovarian ageing. Decrease in follicle numbers dictates the onset of cycle irregularity and the cessation of menses. At the same time, decaying in oocyte quality contributes to the gradual decline in fertility. Endocrine changes mainly depend on the decline in the negative feedback by ovarian factors at the hypothalamo-pituitary unit. The declining antral follicle cohort(AFC) with age first results in gradually elevated FSH levels. The gradual decline in the size of AFC is best represented by decreasing levels of anti-Mullerian hormone. The identification of women who have severely decreased ovarian reserve is clinically relevant. Ovarian reserve tests have appeared to be fairly accurate in predicting response to ovarian stimulation in the assisted reproductive technology (ART) setting. The capacity to predict the chances for spontaneous pregnancy or pregnancy after ART appears very limited. As menopause and the preceding decline in oocyte quality seem to have a fixed time interval, tests that predict the age at menopause may be useful to assess individual reproductive lifespan like genetic studies, ovarian ageing mechanism studies and epigenetic studies.
Heart disease remains a major cause of death among women in China. We focuses on physiologic endogenous sex steroid levels and heart disease especially for CAD among postmenopausal women with natural or surgical menopause. Now there are more and more reasons to seek evidence for associations of circulating estrogen or other endogenous sex steroid levels and CAD. In the future, we design a cohort study to confirm whether ovarian sex steroid hormonal changes is associated with CAD postmenopausal women, or there may be other components explaining the gender differences in CAD patterns.
Premature ovarian failure(POF), is a disorder of infertility characterized by amenorrhoea, low estrogen levels and increased gonadotropin levels in women aged <40 years. POF is the result of premature exhaustion of the follicle pool or can be attributed to follicular dysfunction, for example, owing to mutations in the FSH receptor or steroidogenic cell autoimmunity. Moreover, advances in cancer therapeutics over the past decades have led to increasing survival rates for both paediatric and adult malignancies. Given the gonadotoxic effect of many cancer treatments, more women develop POF. Markers that predict whether women are at risk of POF would, therefore, aid in early diagnosis and fertility counselling.
The history of past and present status has been taken in our research. Women on the process of natural aging and disease-induced ovarian aging are all included. The key factors that influence ovary aging may be identified by epidemiological and molecular biological research.
- Conditions
- Female Infertility Due to Diminished Ovarian Reserve, Menopausal Syndrome, Sexual Function and Fertility Disorders, Cardiovascular Diseases
- Keywords
- ovarian function, female, Genital Function
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
ovarian function evaluation including parameters FSH(mIu/ml), LH(mIu/ml), E2(pg/ml), T(ng/dl) for individuals with normal ovarian function (more than 2 000 women) and ovarian failure(more than 1 000 women).
FSH(mIu/ml), LH(mIu/ml), E2(pg/ml), T(ng/dl) levels were measured using a chemiluminescence-based immunometric assay on an ADVIA Centaur immunoassay system (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA).
Measured: up to 3 year
Secondary outcomes (1)
women's reproductive function including pregnancy rate
pregnancy rate was recorded once a year
Measured: up to 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startJul 2011
- Primary completionMay 2016 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Female Infertility Due to Diminished Ovarian ReserveStudies 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
- 6,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Shixuan Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Huazhong University of Science and Technology, Wuhan General Hospital of Guangzhou Military Command, Zhengzhou University, Shanghai Jiao Tong University School of Medicine, Xinjiang Medical University, Sun Yat-sen University
- Responsible party
- Sponsor-investigator, Shixuan Wang, Huazhong University of Science and Technology
- Investigators
- Shixuan Wang, MD.PHD., Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294500
- Sponsor's protocol ID
- OA-1-female
- Status last verified
- Apr 2016
- First submitted
- 10 Sep 2014
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wen J, Huang K, Du X, Zhang H, Ding T, Zhang C, Ma W, Zhong Y, Qu W, Liu Y, Li Z, Deng S, Luo A, Jin Y, Zhang J, Wang S. Can Inhibin B Reflect Ovarian Reserve of Healthy Reproductive Age Women Effectively? Front Endocrinol (Lausanne). 2021 Apr 14;12:626534. doi: 10.3389/fendo.2021.626534. eCollection 2021.
PubMed 33935966Du X, Ding T, Zhang H, Zhang C, Ma W, Zhong Y, Qu W, Zheng J, Liu Y, Li Z, Huang K, Deng S, Ma L, Yang J, Jiang J, Yang S, Huang J, Wu M, Fang L, Lu Y, Luo A, Wang S. Age-Specific Normal Reference Range for Serum Anti-Mullerian Hormone in Healthy Chinese Han Women: A nationwide Population-Based Study. Reprod Sci. 2016 Aug;23(8):1019-27. doi: 10.1177/1933719115625843. Epub 2016 Jan 13.
PubMed 26763552
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Cohort Study to Evaluate and to Protect Ovarian Function and Reproductive Function
- ClinicalTrials.gov ID
- NCT02294500
- Acronym / sponsor ID
- OA-1-female
- Conditions
- Female Infertility Due to Diminished Ovarian Reserve, Menopausal Syndrome, Sexual Function and Fertility Disorders, Cardiovascular Diseases
- Keywords
- ovarian function, female, Genital Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Shixuan WangUniversity, hospital or other
- Collaborators
- Huazhong University of Science and Technology, Wuhan General Hospital of Guangzhou Military Command, Zhengzhou University, Shanghai Jiao Tong University School of Medicine, Xinjiang Medical University, Sun Yat-sen University
- Study start
- Jul 2011
- Primary completion
- May 2016 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 19 Nov 2014 (estimated)
- 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 will collect the clinical and biological data of the patients, the investigators could further analyse and identify the risk factors and optimize clinical treatment method. Besides, population-based healthy people with informed consent are also collected.
Detailed description
Menopause is the last step in the process of ovarian ageing. Decrease in follicle numbers dictates the onset of cycle irregularity and the cessation of menses. At the same time, decaying in oocyte quality contributes to the gradual decline in fertility. Endocrine changes mainly depend on the decline in the negative feedback by ovarian factors at the hypothalamo-pituitary unit. The declining antral follicle cohort(AFC) with age first results in gradually elevated FSH levels. The gradual decline in the size of AFC is best represented by decreasing levels of anti-Mullerian hormone. The identification of women who have severely decreased ovarian reserve is clinically relevant. Ovarian reserve tests have appeared to be fairly accurate in predicting response to ovarian stimulation in the assisted reproductive technology (ART) setting. The capacity to predict the chances for spontaneous pregnancy or pregnancy after ART appears very limited. As menopause and the preceding decline in oocyte quality seem to have a fixed time interval, tests that predict the age at menopause may be useful to assess individual reproductive lifespan like genetic studies, ovarian ageing mechanism studies and epigenetic studies.
Heart disease remains a major cause of death among women in China. We focuses on physiologic endogenous sex steroid levels and heart disease especially for CAD among postmenopausal women with natural or surgical menopause. Now there are more and more reasons to seek evidence for associations of circulating estrogen or other endogenous sex steroid levels and CAD. In the future, we design a cohort study to confirm whether ovarian sex steroid hormonal changes is associated with CAD postmenopausal women, or there may be other components explaining the gender differences in CAD patterns.
Premature ovarian failure(POF), is a disorder of infertility characterized by amenorrhoea, low estrogen levels and increased gonadotropin levels in women aged <40 years. POF is the result of premature exhaustion of the follicle pool or can be attributed to follicular dysfunction, for example, owing to mutations in the FSH receptor or steroidogenic cell autoimmunity. Moreover, advances in cancer therapeutics over the past decades have led to increasing survival rates for both paediatric and adult malignancies. Given the gonadotoxic effect of many cancer treatments, more women develop POF. Markers that predict whether women are at risk of POF would, therefore, aid in early diagnosis and fertility counselling.
The history of past and present status has been taken in our research. Women on the process of natural aging and disease-induced ovarian aging are all included. The key factors that influence ovary aging may be identified by epidemiological and molecular biological research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women with normal ovarian function or decreased ovarian function
Key inclusion criteria (10 listed)
- Karnofsky Performance Statue ≥ 70,
- WBC > 3,000/mm³,
- Hb > 9.0g/dl,
- Platelet > 100,000 /mm³,
- SGOT/SGPT < 60 IU/L,
Key exclusion criteria (3 listed)
- Patients without information,
- clinical risk factors,
- Patients who have active infection.
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
ovarian function evaluation including parameters FSH(mIu/ml), LH(mIu/ml), E2(pg/ml), T(ng/dl) for individuals with normal ovarian function (more than 2 000 women) and ovarian failure(more than 1 000 women).
Time frame: up to 3 year
FSH(mIu/ml), LH(mIu/ml), E2(pg/ml), T(ng/dl) levels were measured using a chemiluminescence-based immunometric assay on an ADVIA Centaur immunoassay system (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA).
1 secondary outcome
women's reproductive function including pregnancy rate
Time frame: up to 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Derived from this study: PubMed 33935966Wen J, Huang K, Du X, Zhang H, Ding T, Zhang C, Ma W, Zhong Y, Qu W, Liu Y, Li Z, Deng S, Luo A, Jin Y, Zhang J, Wang S. Can Inhibin B Reflect Ovarian Reserve of Healthy Reproductive Age Women Effectively? Front Endocrinol (Lausanne). 2021 Apr 14;12:626534. doi: 10.3389/fendo.2021.626534. eCollection 2021.
- Derived from this study: PubMed 26763552Du X, Ding T, Zhang H, Zhang C, Ma W, Zhong Y, Qu W, Zheng J, Liu Y, Li Z, Huang K, Deng S, Ma L, Yang J, Jiang J, Yang S, Huang J, Wu M, Fang L, Lu Y, Luo A, Wang S. Age-Specific Normal Reference Range for Serum Anti-Mullerian Hormone in Healthy Chinese Han Women: A nationwide Population-Based Study. Reprod Sci. 2016 Aug;23(8):1019-27. doi: 10.1177/1933719115625843. Epub 2016 Jan 13.
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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.
Shixuan Wang, MD.PHD. study chair
Huazhong University of Science and Technology
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 Female Infertility Due to Diminished Ovarian Reserve and Menopausal Syndrome, run by Shixuan Wang 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 3 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 27 Apr 2016. 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 Shixuan Wang (86-27-8366-3078, sxwang2012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ovarian function evaluation including parameters FSH(mIu/ml), LH(mIu/ml), E2(pg/ml), T(ng/dl) for individuals with normal ovarian function (more than 2 000 women) and ovarian failure(more than 1 000 women). (time frame: up to 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02294500, which also lists 2 linked publications.
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 27 Apr 2016.