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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synthetic vitamin C | Experimental | Participants will take the synthetic vitamin C twice a day, 500mg per time. |
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| Natural vitamin C | Experimental | Participants will take the natural vitamin C twice a day, 500mg per time. |
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| Placebo | Placebo Comparator | Participants will take tablets with the same texture, flavor, and appearance as the experimental group twice a day, 500mg per time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C (Ascorbic Acid) | Dietary Supplement | Participants swallow synthetic vitamin C tablets 500mg with water, twice a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| FSH level | Follicle-stimulating hormone (FSH): Test the blood FSH level of women. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian Tian | Contact | +8601082266355 | tiantianpku@126.com |
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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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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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A double-blind design was employed for researchers were designed to be blinded. Allocation concealment was designed to apply to study subjects, clinical practitioners, outcome assessors and subsequent data analysts. The pharmaceutical company assigned numbers and labels to the drugs, and when study subjects were enrolled, they were assigned the corresponding drug number. The specific group corresponding to the number remained concealed from the project researchers, participants, and study subjects, with the blind data kept by independent personnel.
After the follow-up, independent personnel who maintained the blind data provided group information to the data analysts. The synthetic vitamin C, natural vitamin C and control groups were still represented as A, B and C, concealing the specific identities of the ABC groups from the data analysts. After the data comparison between the two groups the unblinding of the AB groups was conducted.
| Vitamin C (Ascorbic Acid) | Dietary Supplement | Participants swallow naturral vitamin C tablets 500mg with water, twice a day. |
|
| Placebo | Other | Participants swallow tablets with the same texture, flavor, and appearance as the experimental group 500mg with water, twice a day. |
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| 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. | 12 months |
| Clinical pregnancy rate | A clinical pregnancy is a pregnancy that is confirmed by ultrasound. | 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. | 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. | 12 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |