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Diminished Ovarian ReserveDORIVF-VCNCT06794047

The Effect of VitC on IVF Outcome of DOR Patients

A study testing Vitamin C in people with Diminished Ovarian Reserve and IVF Outcomes, run by Peking University Third Hospital at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In the context of the accelerating aging population and the continuous decline in birth rates nationwide, delaying reproductive aging in women and protecting the fertility of women of childbearing age have become urgent issues and key demands that need to be addressed in the field of maternal and child health in… Read more about this study

Who is it for?
Ages 20 to 45 years, women only
Conditions the study is for
Diminished Ovarian Reserve, IVF Outcomes
What is being tested?
Vitamin C
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,100 participants
Where
6 sitesChina
Study dates
17 Mar 2025to 31 Dec 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 20 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Definition of DOR: Currently, there is no internationally unified standard for DOR. According to the latest POSEIDON criteria for diminished ovarian reserve (DOR), serum AMH <1.20 ng/mL or bilateral antral follicle count (AFC) <5 is classified as DOR.

In this study, the participants are primarily DOR patients, with the following inclusion criteria:

  • Infertile women undergoing their 1st or 2nd IVF treatment
  • Diagnosed with DOR: POSEIDON criteria (AMH <1.2 ng/mL or bilateral AFC <5) BMI between 18.5-28.0 kg/m²
  • Signed informed consent

Exclusion Criteria:Participants meeting any of the following criteria will be excluded from the trial:

  • PGT (preimplantation genetic testing) candidates
  • DOR caused by ovarian surgery, cancer radiotherapy/chemotherapy
  • Other ovulation disorders (e.g., PCOS, Cushing's syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia) or endometriosis (chocolate cysts)
  • Severe thyroid disorders: Hyperthyroidism, Graves' disease, Hashimoto's thyroiditis
  • Acute/chronic renal insufficiency, hemodialysis, or history of severe kidney impairment
  • Infectious diseases: HIV, active hepatitis, metabolic acidosis, tuberculosis, etc.
  • Severe autoimmune diseases (e.g., rheumatoid arthritis, lupus, Crohn's disease)
  • Cardiovascular events within the past 3 months: Coronary artery disease/myocardial infarction/clinically significant congestive heart failure;Stroke/transient ischemic attack (TIA);Deep vein thrombosis/pulmonary embolism;Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥90 mmHg);Diagnosed diabetes mellitus;Coronary intervention (PCI) or coronary artery bypass grafting (CABG);
  • Neurological disorders (e.g., dementia,Alzheimer's, Parkinson's) or use of related medications
  • Psychiatric disorders or use of antiepileptic/antidepressant drugs
  • History of cancer or radiotherapy/chemotherapy
  • Allergy to vitamin C
  • Current high-dose vitamin C supplementation (>500 mg/day)
  • Unwillingness to take the study-provided supplements
  • Alcohol abuse, smoking, or drug addiction
  • Participation in other clinical trials within the past month

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tian Tian, Ph.D contact

+86 01082266355

tiantianpku@126.com

6 sites in 1 country

China6 sites, 6 recruiting
  • Beijing Obstetrics and Gynecology Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100026

    Xiaokui Yang, Professor, +86 13552326071, xiaokuiyang2012@163.com

    Recruiting
  • Peking university third hospital

    Beijing, Beijing Municipality, 100191

    Tian Tian, Ph.D, 010-82266355, tiantianpku@126.com

    Recruiting
  • Peking University Shenzhen Hospital

    Shenzhen, Shenzhen, 518036

    Xi Xia, Professor, +86 15989897064, mzzqj@126.com

    Recruiting
  • The second hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050061

    Guimin Hao, Professor, +86 13623218091, haoguimin@163.com

    Recruiting
  • Tang Du Hospital

    Xi’an, Shanxi, 710038

    Xiaohong Wang, Professor, +86 18165178306, wangxh-99919@163.com

    Recruiting
  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

    Junli Zhao, Professor, +86 15825310348, zhaojunli6812@163.com

    Recruiting

Other trials in China

About this study

Official title: The Effect of Vitamin C Supplementation on Assisted Reproductive Pregnancy Outcomes in Patients With Diminished Ovarian Reserve: A Multicenter, Double-blind, Randomized Controlled Trial.

In the context of the accelerating aging population and the continuous decline in birth rates nationwide, delaying reproductive aging in women and protecting the fertility of women of childbearing age have become urgent issues and key demands that need to be addressed in the field of maternal and child health in China. The ovaries have reproductive and hormone secretion functions and are crucial throughout the female reproductive lifecycle. Women of childbearing age in China face a serious problem of diminished ovarian reserve (DOR), which can lead to infertility, failed in vitro fertilization (IVF) treatments, miscarriage, and other adverse pregnancy outcomes, severely affecting the safety of women and their offspring. For DOR patients who desire to conceive, failure to intervene and treat promptly can result in irreversible losses and impose a significant psychological burden on them. However, there are currently no clear and reliable interventions that can improve ovarian function and enhance fertility in women with DOR. Therefore, exploring new, safe, and patient-acceptable intervention strategies is urgently needed, as it may bring hope and light to women with DOR. Nutrient supplementation, especially vitamin supplementation, has received increasing attention in disease treatment due to its safety, bioavailability, and effectiveness. Previous studies have shown that vitamin C may play an important role in treating diminished ovarian reserve. However, its effects on ovarian function need to be validated in the population.

Based on the above research background, this project will conduct a randomized, placebo-controlled, double-blind, multicenter trial. The study subjects will be DOR infertility patients undergoing IVF/ICSI treatment. The intervention group will receive oral vitamin C supplementation at a dosage of 500 mg per dose, twice a day; the control group will receive a placebo with the same dosage and method for at least three months. Patients will be followed up until delivery outcomes, comparing the IVF/ICSI treatment results between the vitamin C supplementation group and the placebo group. The primary endpoint of this clinical trial is the live birth rate of the IVF/ICSI treatment cycle. Secondary endpoints include indicators of improved ovarian reserve function, ovarian aging molecular clocks, IVF-embryo culture indicators, pregnancy rates, pregnancy complications, and neonatal conditions, thereby providing new clues and theoretical basis for clinical treatment plans for DOR patients.

Being tested
Vitamin C, Placebo
Keywords
vitamin C, IVF outcomes, livebirth, diminished ovarian reserve

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin CDietary supplement

    Also called VitC, VC, Ascorbic acid

    Vitamin C tablets, please instruct the patient to swallow with water, 500mg twice daily, morning and evening.

  • PlaceboOther

    Also called control

    Tablets with the same material, flavor, and appearance as the intervention group.

Study groups in NCT06794047
Study groupRoleWhat they receive
VitCExperimentalThe women will intake the vitamin C twice a day, 500mg per time.
Receives: Dietary Supplement: Vitamin C
PlaceboPlacebo comparatorTablets with the same material, flavor, and appearance as the intervention group.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live birth rate

    The main outcome of this trial is the live birth resulting from a sustained pregnancy after the first embryo transfer within 6 months for patients undergoing fresh transfer cycles or frozen embryo cycles.

    Live birth rate (%) = Number of subjects with live births in each group / Total number of subjects in each group × 100%.

    Measured: 1 year after oocyte retrieval following embryo transfer

Secondary outcomes (30)
  1. Cumulative live birth rate

    Live births within 1 year after oocyte retrieval following embryo transfer; calculated as: (Final number of live births / Number of randomized participants) × 100%

    Measured: 1 year after oocyte retrieval following embryo transfer

  2. Singleton live birth rate

    (Number of singleton live births / Number of randomized participants) × 100%

    Measured: 1year after oocyte retrieval following embryo transfer

  3. Twin live birth rate

    (Number of women with twin live births / Number of randomized participants) × 100%

    Measured: 1 year after oocyte retrieval following embryo transfer

  4. Clinical pregnancy rate

    Presence of at least one gestational sac (including intrauterine and ectopic) confirmed by transvaginal ultrasound 28-30 days after embryo transfer; includes singleton pregnancy rate and twin pregnancy rate (twin and multiple pregnancy rates should be reported along with pregnancy loss rate)

    Measured: 28-30 days after embryo transfer

  5. Ongoing pregnancy

    Presence of at least one gestational sac with fetal heartbeat confirmed by transvaginal ultrasound at 12 weeks after embryo transfer.

    Measured: 12 weeks after embryo transfer.

  6. Time to pregnancy leading to live birth

    or participants who achieved live birth, the time from intervention initiation to clinically confirmed pregnancy (confirmed by ultrasound 30 days after transfer). Survival analysis will be used to compare between intervention and control groups.

    Measured: 1 year after oocyte retrieval following embryo transfer

  7. Number of oocytes retrieved

    Number of oocytes retrieved

    Measured: 3 to 12 months from enrollment

  8. Number of normally fertilized oocytes

    On Day 1 post-retrieval, oocytes with two pronuclei (2PN) are counted as normally fertilized.

    Measured: Day 1 post-retrieval

  9. Total fertilization failure

    No oocytes in the current treatment cycle show 2PN after fertilization or injection.

    Measured: Day 1 post-retrieval

  10. Number of usable embryos

    On Day 3 post-retrieval, embryos with ≥4 cells and ≤30% fragmentation are considered usable.

    Measured: On Day 3 post-retrieval

  11. Number of high-quality embryos

    On Day 3 post-retrieval, 2PN-derived embryos with ≥6 cells and ≤10% fragmentation are classified as high-quality.

    Measured: On Day 3 post-retrieval

  12. Number of implanted embryos

    The number of gestational sacs (including intrauterine and ectopic) detected by transvaginal ultrasound 28-30 days after embryo transfer.

    Measured: 28-30 days after embryo transfer.

  13. Ectopic pregnancy

    A pregnancy occurring outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology.

    Measured: 1 year after oocyte retrieval following embryo transfer

  14. Miscarriage

    Spontaneous loss of an intrauterine pregnancy before 20 weeks of gestation. This should occur after ultrasound confirmation of a viable pregnancy.

    Measured: 1 year after oocyte retrieval following embryo transfer

  15. Stillbirth

    Fetal death occurring after 20 weeks of gestation, before complete expulsion or extraction. Death is determined by the absence of breathing or other signs of life (e.g., heartbeat, umbilical cord pulsation, or definite voluntary movement) after delivery.

    Measured: 1 year after oocyte retrieval following embryo transfer

  16. Termination of pregnancy

    Medical, surgical, or other artificial termination of an intrauterine pregnancy (including fetal reduction procedures).

    Measured: 1 year after oocyte retrieval following embryo transfer

  17. Moderate or severe ovarian hyperstimulation syndrome (OHSS)

    OHSS is primarily characterized by cystic enlargement of the ovaries, increased vascular permeability, third-space fluid accumulation (resulting in ascites and pleural effusion), and localized or generalized edema.)

    Measured: 1 year after oocyte retrieval following embryo transfer

  18. Pregnancy complications

    Including gestational diabetes mellitus, hypertensive disorders of pregnancy, antepartum hemorrhage, etc.

    Measured: 1 year after oocyte retrieval following embryo transfer

  19. Gestational age

    The number of weeks from fertilization to delivery, plus 14 days.

    Measured: 1 year after oocyte retrieval following embryo transfer

  20. Preterm birth

    Birth occurring before 37 weeks of gestation (i.e., fewer than 259 days of pregnancy).

    Measured: 1 year after oocyte retrieval following embryo transfer

  21. Birth weight

    The weight of the newborn at birth. Abnormal birth weight includes: Low birth weight (LBW): <2,500 g Very low birth weight (VLBW): <1,500 g High birth weight (macrosomia): >4,000 g Very high birth weight: >4,500 g

    Measured: 1 year after oocyte retrieval following embryo transfer

  22. Large for gestational age (LGA)

    Newborns with birth weight above the 90th percentile for their gestational age and sex.

    Measured: 1 year after oocyte retrieval following embryo transfer

  23. Small for gestational age (SGA)

    Newborns with birth weight below the 10th percentile for their gestational age and sex.

    Measured: 1 year after oocyte retrieval following embryo transfer

  24. Neonatal death

    Death of a live-born infant within 28 days after birth. This can be further categorized as:

    Early neonatal death: Death occurring within the first 7 days of life. Late neonatal death: Death occurring between 8 and 28 days of life.

    Measured: 1 year after oocyte retrieval following embryo transfer

  25. Birth defect

    Structural, functional, or genetic abnormalities occurring during pregnancy, which may be identified prenatally, at birth, or postnatally, and may be life-threatening or fatal. Major congenital anomalies should be reported as infants with at least one major congenital anomaly detected. If a major birth defect is identified in a multiple pregnancy, it should be explicitly reported.

    Measured: 1 year after oocyte retrieval following embryo transfer

  26. Possible Vitamin C Side Effects-Abdominal Pain and Diarrhea:

    A single high dose (5-10 g) of vitamin C may cause transient osmotic diarrhea and/or abdominal bloating. However, the human body has a high tolerance, and even such high doses are generally safe. Typically, these symptoms gradually improve or disappear after continued use.

    Measured: 1 year

  27. Possible Vitamin C side effect--Hyperuricemia

    Hyperuricemia: Vitamin C can be partially metabolized into oxalate and dose-dependently increase oxalate levels in urine. High doses of vitamin C may temporarily increase uric acid excretion, while high-dose intravenous administration may stimulate polyuria. Therefore, the daily recommended dose of vitamin C should not exceed 1 gram. Urine routine tests will be conducted during follow-up.

    Measured: 1 year

  28. Possible Vitamin C side effect--Kidney stones

    Some studies have found that high-dose oral vitamin C significantly increases the risk of kidney stone formation in men by 41%. Additionally, long-term high concentrations of oxalate in urine may contribute to stone formation. Thus, high-dose vitamin C supplementation in at-risk populations may lead to urinary tract stones, as self-reported by participants.

    Measured: 1 year

  29. Possible Vitamin C side effect--Hemolysis

    Intravenous or high-dose oral vitamin C may induce hemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency and worsen hemolysis in those with paroxysmal nocturnal hemoglobinuria. If such symptoms occur, vitamin C should be discontinued immediately, medical attention sought, and researchers contacted.

    Measured: 1 year

  30. Vitamin C level after supplementation

    Measured: 3 months to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2025
  2. Study start17 Mar 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06794047
Sponsor's protocol ID
M2024646
Other IDs
No2024
Acronym
DORIVF-VC
Status last verified
Jun 2025
First submitted
8 Jan 2025
Last updated
17 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.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin C in people with Diminished Ovarian Reserve and IVF Outcomes, run by Peking University Third Hospital at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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. 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, Ph.D (+86 01082266355, tiantianpku@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth rate (time frame: 1 year after oocyte retrieval following embryo transfer). 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 17 Jun 2025.

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