Premature Ovarian InsufficiencyNCT06794060
Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging
A study testing Vitamin C (Ascorbic Acid) in people with Premature Ovarian Insufficiency and Ovarian Reserve Function, run by Peking University Third Hospital.
Trial summary
The goal of this clinical trial is to learn if Vitamin C works to improve ovarian reserve in women with ovarian aging. It will also learn about the safety of Vitamin C. The main questions it aims to answer are: Does Vitamin C supplementation improve the ovarian reserve prediction score? What medical problems do… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premature Ovarian Insufficiency, Ovarian Reserve Function
- What is being tested?
- Vitamin C (Ascorbic Acid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- No sites listed yet
- Study dates
- 2 Jul 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Regularity of menstruation changed for less than one year.
- 10U/L≤ FSH<25 U/L in two tests more than 4weeks aprt.
- AMH < 1.1 ng/mL.
- Bilateral ovarian AFC <7.
- Signed informed consent and can participate in regular follow-ups.
Who cannot join
- Ovarian aging caused by TUNER (X deletion) syndrome or gene mutation.
- Ovarian aging caused by ovarian surgery or chemotherapy.
- Patients with severe endocrine system diseases (diabetes, thyroid disease), digestive system diseases (affecting VC absorption), cardiovascular system diseases, renal insufficiency (abnormal urine, imaging diagnosis, blood, pathological analysis confirms that kidney damage does exist, or glomerular filtration rate GFR <60mL/min), nervous system diseases such as dementia and epilepsy; patients with infectious diseases such as HIV, hepatitis, tuberculosis; patients with severe autoimmune diseases.
- Continuous alcohol or drug abuse (to avoid adverse reactions caused by drinking).
- Allergic to vitamin C or any component of the preparation.
- Patients who have already started large-dose (greater than 500mg/day) vitamin C supplementation.
- Unwilling to or stop taking supplements not provided by this project.
- Those who have participated in other ovarian aging clinical intervention projects.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging：a Multicenter, Double-blind, Randomized Controlled Trial
The goal of this clinical trial is to learn if Vitamin C works to improve ovarian reserve in women with ovarian aging. It will also learn about the safety of Vitamin C. The main questions it aims to answer are:
- Does Vitamin C supplementation improve the ovarian reserve prediction score?
- What medical problems do participants have when taking Vitamin C supplementation?
Read more
Researchers will compare Vitamin C to a placebo (a look-alike substance that contains no drug) to see if drug Vitamin C works to improve ovarian reserve in women with ovarian aging. Participants will:
- Take Vitamin C or a placebo every day for 12 months
- Visit the clinic once every 4 weeks for follow-up and drug distribution.
- Return the Vitamin C box at each visit.
- Report any adverse effects of treatment to the doctor.
- Fill out a questionnaire at each visit.
- After 6 months and 12 months of intervention, take blood test and ultrasonic examination.
- Being tested
- Vitamin C (Ascorbic Acid), Placebo
- 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.
Vitamin C (Ascorbic Acid)Dietary supplement
Participants swallow synthetic vitamin C tablets 500mg with water, twice a day.
Vitamin C (Ascorbic Acid)Dietary supplement
Participants swallow naturral vitamin C tablets 500mg with water, twice a day.
PlaceboOther
Participants swallow tablets with the same texture, flavor, and appearance as the experimental group 500mg with water, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Synthetic vitamin C | Experimental | Participants will take the synthetic vitamin C twice a day, 500mg per time. Receives: Dietary Supplement: Vitamin C (Ascorbic Acid) |
| Natural vitamin C | Experimental | Participants will take the natural vitamin C twice a day, 500mg per time. Receives: Dietary Supplement: Vitamin C (Ascorbic Acid) |
| Placebo | Placebo comparator | Participants will take tablets with the same texture, flavor, and appearance as the experimental group twice a day, 500mg per time. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovarian reserve prediction score
The ovarian reserve prediction score was calculated using the Ovarian Reserve Prediction Tool, OvaRePred. This tool evaluates the current ovarian reserve status and predicts the future age at which diminished ovarian reserve (DOR) and perimenopause may occur. The score ranges from 0 to 100, with higher scores indicating better ovarian function.
Measured: 1 year
Secondary outcomes (6)
FSH level
Follicle-stimulating hormone (FSH): Test the blood FSH level of women.
Measured: 1 year
AMH level
Anti-Müllerian Hormone (AMH) is a hormone produced by the granulosa cells of ovarian follicles. It serves as a key indicator of a woman's ovarian reserve, which refers to the number of viable eggs remaining in the ovaries.
Measured: 12 months
AFC
Antral Follicle Count (AFC), is a measure used in reproductive medicine to assess a woman's ovarian reserve, that can be seen and counted via transvaginal ultrasound.
Measured: 12 months
Clinical pregnancy rate
A clinical pregnancy is a pregnancy that is confirmed by ultrasound.
Measured: 12 months
Time to pregnancy
Time to pregnancy (TTP) refers to the duration it takes for a couple to conceive, starting from the time they begin trying to achieve a pregnancy.
Measured: 12 months
Livebirth rate
A live birth refers to the delivery of a baby who shows any signs of life after being born, regardless of the pregnancy's duration.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start2 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Qiao, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794060
- Sponsor's protocol ID
- M2024647
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have decided not to share the IPD from this study due to concerns about participant privacy and confidentiality. Despite efforts to de-identify the data, there remains a risk of re-identification, which could compromise the privacy of the participants involved. Additionally, there are legal and ethical considerations that restrict the sharing of sensitive health information without explicit consent from the participants. Furthermore, the resources required to prepare and manage the data for external sharing are currently beyond our capacity. Therefore, to ensure the protection of our participants and comply with ethical standards, we have opted not to share the IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Vitamin C Supplementation in Patients With Ovarian Aging：a Multicenter, Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06794060
- Acronym / sponsor ID
- M2024647
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 2 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Jan 2025 (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 goal of this clinical trial is to learn if Vitamin C works to improve ovarian reserve in women with ovarian aging. It will also learn about the safety of Vitamin C. The main questions it aims to answer are:
- Does Vitamin C supplementation improve the ovarian reserve prediction score?
- What medical problems do participants have when taking Vitamin C supplementation?
Researchers will compare Vitamin C to a placebo (a look-alike substance that contains no drug) to see if drug Vitamin C works to improve ovarian reserve in women with ovarian aging. Participants will:
- Take Vitamin C or a placebo every day for 12 months
- Visit the clinic once every 4 weeks for follow-up and drug distribution.
- Return the Vitamin C box at each visit.
- Report any adverse effects of treatment to the doctor.
- Fill out a questionnaire at each visit.
- After 6 months and 12 months of intervention, take blood test and ultrasonic examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Synthetic vitamin C | Experimental | Dietary Supplement: Vitamin C (Ascorbic Acid)Participants will take the synthetic vitamin C twice a day, 500mg per time. |
| Natural vitamin C | Experimental | Dietary Supplement: Vitamin C (Ascorbic Acid)Participants will take the natural vitamin C twice a day, 500mg per time. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will take tablets with the same texture, flavor, and appearance as the experimental group twice a day, 500mg per time. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Regularity of menstruation changed for less than one year.
- 10U/L≤ FSH<25 U/L in two tests more than 4weeks aprt.
- AMH < 1.1 ng/mL.
- Bilateral ovarian AFC <7.
- Signed informed consent and can participate in regular follow-ups.
Key exclusion criteria (8 listed)
- Ovarian aging caused by TUNER (X deletion) syndrome or gene mutation.
- Ovarian aging caused by ovarian surgery or chemotherapy.
- Patients with severe endocrine system diseases (diabetes, thyroid disease), digestive system diseases (affecting VC absorption), cardiovascular system diseases, renal insufficiency (abnormal urine, imaging diagnosis, blood, pathological analysis confirms that kidney damage does exist, or glomerular filtration rate GFR <60mL/min), nervous system diseases such as dementia and epilepsy; patients with infectious diseases such as HIV, hepatitis, tuberculosis; patients with severe autoimmune diseases.
- Continuous alcohol or drug abuse (to avoid adverse reactions caused by drinking).
- Allergic to vitamin C or any component of the preparation.
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 |
|---|---|---|
| Vitamin C (Ascorbic Acid)Participants swallow synthetic vitamin C tablets 500mg with water, twice a day. | Dietary supplement | Synthetic vitamin C |
| Vitamin C (Ascorbic Acid)Participants swallow naturral vitamin C tablets 500mg with water, twice a day. | Dietary supplement | Natural vitamin C |
| PlaceboParticipants swallow tablets with the same texture, flavor, and appearance as the experimental group 500mg with water, twice a day. | Other | Placebo |
Primary outcome
ovarian reserve prediction score
Time frame: 1 year
The ovarian reserve prediction score was calculated using the Ovarian Reserve Prediction Tool, OvaRePred. This tool evaluates the current ovarian reserve status and predicts the future age at which diminished ovarian reserve (DOR) and perimenopause may occur. The score ranges from 0 to 100, with higher scores indicating better ovarian function.
6 secondary outcomes
FSH level
Time frame: 1 year
AMH level
Time frame: 12 months
AFC
Time frame: 12 months
Clinical pregnancy rate
Time frame: 12 months
Time to pregnancy
Time frame: 12 months
Livebirth rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No. We have decided not to share the IPD from this study due to concerns about participant privacy and confidentiality. Despite efforts to de-identify the data, there remains a risk of re-identification, which could compromise the privacy of the participants involved. Additionally, there are legal and ethical considerations that restrict the sharing of sensitive health information without explicit consent from the participants. Furthermore, the resources required to prepare and manage the data for external sharing are currently beyond our capacity. Therefore, to ensure the protection of our participants and comply with ethical standards, we have opted not to share the IPD at this time.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C (Ascorbic Acid) in people with Premature Ovarian Insufficiency and Ovarian Reserve Function, run by Peking University Third Hospital.
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: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tian Tian (+8601082266355, tiantianpku@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ovarian reserve prediction score (time frame: 1 year). 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 26 Jun 2025.