Premature Ovarian FailureNCT06121388
Brain MRI Imaging Changes and Associated Factors on Cognition Function in Patients With Premature Ovarian Failure
An observational study of Premature Ovarian Failure, run by International Peace Maternity and Child Health Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the brain MRI imaging changes and associated factors on cognition function in patients with premature ovarian failure. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ovarian Failure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- 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
- Healthy volunteers accepted
- Adult
Study population: 50 premature ovarian failure patients of age 18-40 treated in the International Peace Maternity and Child Health Hospital. 50 women with similar age, BMI, working environment, education level and regular menstrual cycle in our hospital, and conduct endocrine examination for health examination.
Who may be able to join
- 1. Criteria for premature ovarian failure:
- Subjects must meet all the following criteria to be included in the study:
- Female, between 18 and 40 years old;
- FSH ≥ 40U/L on two occasions at least four weeks;
- Sign informed consent. 2. Criteria for the health control group: According to the case control principle, at the same time, the investigators select women with similar age, BMI, working environment, education level and regular menstrual cycle in our hospital, and conduct endocrine examination (FSH <10U/L) for health examination.
Who cannot join
- Pregnancy or lactation;
- Patients with secondary ovarian insufficiency (such as causes of the hypothalamus);
- Chromosomal karyotype abnormalities (such as Turner syndrome, brittle X syndrome);
- Any disease that requires immediate blood transfusion;
- Abuse of alcohol, drugs or drugs (for example, laxatives)
- Allergies to MRI contrast agents;
- Accompanied by metal implants, claustrophobia and other magnetic resonance scanning contraindications;
- Accompanied by serious brain organic diseases, such as epilepsy, stroke, encephalitis, brain trauma, and so on. Nervous system diseases, such as Parkinson's disease, have other cognitive-impacting diseases, or serious somatic diseases such as malignant tumors, acute heart failure, multi-organ failure, and so on.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The International Peace Maternity and Child Health Hospital
Shanghai, Shanghai Municipality, 200030
Dongmei Lai, M.D, 86-21-64070434-27701, laidongmei@hotmail.com
Qian Wang, pH.D, 86-21-64070434-27721, PAULIA@163.COM
About this study
Official title: International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
The purpose of this study is to investigate the brain MRI imaging changes and associated factors on cognition function in patients with premature ovarian failure.
Read the detailed description
Premature Ovarian Failure (POF) refers to a disease characterized by amenorrhea, infertility, low estrogen levels, and high gonadotropin concentration in women before the age of 40. In recent years, the incidence has shown a significant increase. The average age of POF in China is 28.9 years old, involving 2 million women of childbearing age. POF patients have significant emotional disorders and cognitive changes, but it is not known whether the structure and function of the POF patients' brain have changed. It is known that the perimenopause (i.e. estrogen decline) may be the early stage of AD. Therefore, this study aims to use brain imaging technology to explore the changes of brain injury in POF patients with the progression of the disease to achieve early assessment of AD in POF patients. The research work of this project is mainly based on multimodal magnetic resonance imaging technology. For the clinical phenomenon of brain dysfunction in POF patients, it analyzes the changes in brain structure and brain function of POF patients for the first time. Using artificial intelligence brain network analysis method, from the perspective of brain structure and brain function, to determine whether there is microstructural transformation of white matter in POF patients and whether it is related to disease progression and serological indicators. Through the implementation of this project, it provides a basis for brain structure and functional changes for the diagnosis and treatment of POF, and provides a basis for large-scale clinical research to guide clinical formulation of reasonable diagnosis and treatment plans and prognosis evaluation.
- Conditions
- Premature Ovarian Failure
- Keywords
- Premature Ovarian Failure, brain MRI, cognition function
- 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.
| Study group | Role | What they receive |
|---|---|---|
| health control group | Health control women with similar age, BMI, working environment, education level and regular menstrual cycle in our hospital, and conduct endocrine examination for health examination. | |
| premature ovarian failure group | Patients are diagnosed with premature ovarian failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain structure
Brain structure will be assessed by MRI.
Measured: 1 year
Secondary outcomes (6)
Follicle-stimulating hormone (FSH) serum level
Follicle-stimulating hormone (FSH) serum level will be tested.
Measured: 1 year
Luteinizing hormone (LH) serum level
Luteinizing hormone (LH) serum level will be tested.
Measured: 1 year
Estradiol (E2) serum level
Estradiol (E2) serum level will be tested.
Measured: 1 year
Testosterone (T) serum level
Testosterone (T) serum level will be tested.
Measured: 1 year
Prolactin (PRL) serum level
Prolactin (PRL) serum level will be tested.
Measured: 1 year
Anti-müllerian hormone (AMH) serum level
Anti-müllerian hormone (AMH) serum level will be tested.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongmei Lai, International Peace Maternity and Child Health Hospital
- Investigators
- Dongmei Lai, M.D., Principal investigator, The International Peace Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121388
- Sponsor's protocol ID
- GFY2023007
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The public can require the data and protocol from clinicaltrials.gov posted by investigator.
Publications
Brown A, Gervais NJ, Rieck J, Almey A, Gravelsins L, Reuben R, Karkaby L, Rajah MN, Grady C, Einstein G. Women's Brain Health: Midlife Ovarian Removal Affects Associative Memory. Mol Neurobiol. 2023 Nov;60(11):6145-6159. doi: 10.1007/s12035-023-03424-6. Epub 2023 Jul 10.
PubMed 37423941Zeydan B, Tosakulwong N, Schwarz CG, Senjem ML, Gunter JL, Reid RI, Gazzuola Rocca L, Lesnick TG, Smith CY, Bailey KR, Lowe VJ, Roberts RO, Jack CR Jr, Petersen RC, Miller VM, Mielke MM, Rocca WA, Kantarci K. Association of Bilateral Salpingo-Oophorectomy Before Menopause Onset With Medial Temporal Lobe Neurodegeneration. JAMA Neurol. 2019 Jan 1;76(1):95-100. doi: 10.1001/jamaneurol.2018.3057.
PubMed 30326011Maki PM, Resnick SM. Effects of estrogen on patterns of brain activity at rest and during cognitive activity: a review of neuroimaging studies. Neuroimage. 2001 Oct;14(4):789-801. doi: 10.1006/nimg.2001.0887.
PubMed 11554798
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
- ClinicalTrials.gov ID
- NCT06121388
- Acronym / sponsor ID
- GFY2023007
- Conditions
- Premature Ovarian Failure
- Keywords
- Premature Ovarian Failure, brain MRI, cognition function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Nov 2023 (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 purpose of this study is to investigate the brain MRI imaging changes and associated factors on cognition function in patients with premature ovarian failure.
Detailed description
Premature Ovarian Failure (POF) refers to a disease characterized by amenorrhea, infertility, low estrogen levels, and high gonadotropin concentration in women before the age of 40. In recent years, the incidence has shown a significant increase. The average age of POF in China is 28.9 years old, involving 2 million women of childbearing age. POF patients have significant emotional disorders and cognitive changes, but it is not known whether the structure and function of the POF patients' brain have changed. It is known that the perimenopause (i.e. estrogen decline) may be the early stage of AD. Therefore, this study aims to use brain imaging technology to explore the changes of brain injury in POF patients with the progression of the disease to achieve early assessment of AD in POF patients. The research work of this project is mainly based on multimodal magnetic resonance imaging technology. For the clinical phenomenon of brain dysfunction in POF patients, it analyzes the changes in brain structure and brain function of POF patients for the first time. Using artificial intelligence brain network analysis method, from the perspective of brain structure and brain function, to determine whether there is microstructural transformation of white matter in POF patients and whether it is related to disease progression and serological indicators. Through the implementation of this project, it provides a basis for brain structure and functional changes for the diagnosis and treatment of POF, and provides a basis for large-scale clinical research to guide clinical formulation of reasonable diagnosis and treatment plans and prognosis evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health control group | – | –Health control women with similar age, BMI, working environment, education level and regular menstrual cycle in our hospital, and conduct endocrine examination for health examination. |
| premature ovarian failure group | – | –Patients are diagnosed with premature ovarian failure. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 50 premature ovarian failure patients of age 18-40 treated in the International Peace Maternity and Child Health Hospital. 50 women with similar age, BMI, working environment, education level and regular menstrual cycle in our hospital, and conduct endocrine examination for health examination.
Key inclusion criteria (5 listed)
- Subjects must meet all the following criteria to be included in the study:
- Female, between 18 and 40 years old;
- FSH ≥ 40U/L on two occasions at least four weeks;
- Sign informed consent. 2. Criteria for the health control group: According to the case control principle, at the same time, the investigators select women with similar age, BMI, working environment, education level and regular menstrual cycle in our hospital, and conduct endocrine examination (FSH <10U/L) for health examination.
Key exclusion criteria (8 listed)
- Pregnancy or lactation;
- Patients with secondary ovarian insufficiency (such as causes of the hypothalamus);
- Chromosomal karyotype abnormalities (such as Turner syndrome, brittle X syndrome);
- Any disease that requires immediate blood transfusion;
- Abuse of alcohol, drugs or drugs (for example, laxatives)
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
Brain structure
Time frame: 1 year
Brain structure will be assessed by MRI.
6 secondary outcomes
Follicle-stimulating hormone (FSH) serum level
Time frame: 1 year
Luteinizing hormone (LH) serum level
Time frame: 1 year
Estradiol (E2) serum level
Time frame: 1 year
Testosterone (T) serum level
Time frame: 1 year
Prolactin (PRL) serum level
Time frame: 1 year
Anti-müllerian hormone (AMH) serum level
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 37423941Brown A, Gervais NJ, Rieck J, Almey A, Gravelsins L, Reuben R, Karkaby L, Rajah MN, Grady C, Einstein G. Women's Brain Health: Midlife Ovarian Removal Affects Associative Memory. Mol Neurobiol. 2023 Nov;60(11):6145-6159. doi: 10.1007/s12035-023-03424-6. Epub 2023 Jul 10.
- Background: PubMed 30326011Zeydan B, Tosakulwong N, Schwarz CG, Senjem ML, Gunter JL, Reid RI, Gazzuola Rocca L, Lesnick TG, Smith CY, Bailey KR, Lowe VJ, Roberts RO, Jack CR Jr, Petersen RC, Miller VM, Mielke MM, Rocca WA, Kantarci K. Association of Bilateral Salpingo-Oophorectomy Before Menopause Onset With Medial Temporal Lobe Neurodegeneration. JAMA Neurol. 2019 Jan 1;76(1):95-100. doi: 10.1001/jamaneurol.2018.3057.
- Background: PubMed 11554798Maki PM, Resnick SM. Effects of estrogen on patterns of brain activity at rest and during cognitive activity: a review of neuroimaging studies. Neuroimage. 2001 Oct;14(4):789-801. doi: 10.1006/nimg.2001.0887.
- Individual participant dataSharing planned: Yes. The public can require the data and protocol from clinicaltrials.gov posted by investigator.
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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.
Dongmei Lai, M.D. principal investigator
The International Peace Maternity and Child Health Hospital
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, run by International Peace Maternity and Child Health Hospital 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 5 inclusion and 8 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 14 Nov 2023. 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 Dongmei Lai, M.D. (86-021-64070434 ext. 27701, laidongmei@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain structure (time frame: 1 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 NCT06121388, which also lists 3 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 14 Nov 2023.