Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06794047 (DORIVF-VC) for Diminished Ovarian Reserve, IVF Outcomes is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
The Effect of VitC on IVF Outcome of DOR Patients (DORIVF-VC) 1,100 Randomized Double-Blind Placebo-Controlled
Clinical Trial NCT06794047 (DORIVF-VC) is an interventional study for Diminished Ovarian Reserve, IVF Outcomes that is recruiting. It started on 17 March 2025 with plans to enroll 1,100 participants. Led by Peking University Third Hospital, it is expected to complete by 31 December 2027. The latest data from ClinicalTrials.gov was last updated on 17 June 2025.
Brief 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 China. The ovaries have reproductive and hormone secretion functions and are crucial throughout the female...Show More
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.
Conditions
Diminished Ovarian ReserveIVF OutcomesOther Study IDs
- DORIVF-VC
- M2024646
- No2024 (Other Grant/Funding Number) (National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, China)
NCT ID Number
Start Date (Actual)
2025-03-17
Last Update Posted
2025-06-17
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
1,100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
vitamin C
IVF outcomes
livebirth
diminished ovarian reserve
IVF outcomes
livebirth
diminished ovarian reserve
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalVitC The women will intake the vitamin C twice a day, 500mg per time. | vitamin C Vitamin C tablets, please instruct the patient to swallow with water, 500mg twice daily, morning and evening. |
Placebo ComparatorPlacebo Tablets with the same material, flavor, and appearance as the intervention group. | Placebo Tablets with the same material, flavor, and appearance as the intervention group. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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%. | 1 year after oocyte retrieval following embryo transfer |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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% | 1 year after oocyte retrieval following embryo transfer |
Singleton live birth rate | (Number of singleton live births / Number of randomized participants) × 100% | 1year after oocyte retrieval following embryo transfer |
Twin live birth rate | (Number of women with twin live births / Number of randomized participants) × 100% | 1 year after oocyte retrieval following embryo transfer |
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) | 28-30 days after embryo transfer |
Ongoing pregnancy | Presence of at least one gestational sac with fetal heartbeat confirmed by transvaginal ultrasound at 12 weeks after embryo transfer. | 12 weeks after embryo transfer. |
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. | 1 year after oocyte retrieval following embryo transfer |
Number of oocytes retrieved | Number of oocytes retrieved | 3 to 12 months from enrollment |
Number of normally fertilized oocytes | On Day 1 post-retrieval, oocytes with two pronuclei (2PN) are counted as normally fertilized. | Day 1 post-retrieval |
Total fertilization failure | No oocytes in the current treatment cycle show 2PN after fertilization or injection. | Day 1 post-retrieval |
Number of usable embryos | On Day 3 post-retrieval, embryos with ≥4 cells and ≤30% fragmentation are considered usable. | On Day 3 post-retrieval |
Number of high-quality embryos | On Day 3 post-retrieval, 2PN-derived embryos with ≥6 cells and ≤10% fragmentation are classified as high-quality. | On Day 3 post-retrieval |
Number of implanted embryos | The number of gestational sacs (including intrauterine and ectopic) detected by transvaginal ultrasound 28-30 days after embryo transfer. | 28-30 days after embryo transfer. |
Ectopic pregnancy | A pregnancy occurring outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology. | 1 year after oocyte retrieval following embryo transfer |
Miscarriage | Spontaneous loss of an intrauterine pregnancy before 20 weeks of gestation. This should occur after ultrasound confirmation of a viable pregnancy. | 1 year after oocyte retrieval following embryo transfer |
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. | 1 year after oocyte retrieval following embryo transfer |
Termination of pregnancy | Medical, surgical, or other artificial termination of an intrauterine pregnancy (including fetal reduction procedures). | 1 year after oocyte retrieval following embryo transfer |
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.) | 1 year after oocyte retrieval following embryo transfer |
Pregnancy complications | Including gestational diabetes mellitus, hypertensive disorders of pregnancy, antepartum hemorrhage, etc. | 1 year after oocyte retrieval following embryo transfer |
Gestational age | The number of weeks from fertilization to delivery, plus 14 days. | 1 year after oocyte retrieval following embryo transfer |
Preterm birth | Birth occurring before 37 weeks of gestation (i.e., fewer than 259 days of pregnancy). | 1 year after oocyte retrieval following embryo transfer |
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 | 1 year after oocyte retrieval following embryo transfer |
Large for gestational age (LGA) | Newborns with birth weight above the 90th percentile for their gestational age and sex. | 1 year after oocyte retrieval following embryo transfer |
Small for gestational age (SGA) | Newborns with birth weight below the 10th percentile for their gestational age and sex. | 1 year after oocyte retrieval following embryo transfer |
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. | 1 year after oocyte retrieval following embryo transfer |
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. | 1 year after oocyte retrieval following embryo transfer |
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. | 1 year |
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. | 1 year |
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. | 1 year |
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. | 1 year |
Vitamin C level after supplementation | 3 months to 1 year |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
20 Years
Eligible Sexes
Female
- 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
- 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
Peking University Third HospitalStudy Responsible Party
Jie Qiao, Principal Investigator, Professor, Peking University Third Hospital
Study Central Contact
Contact: Tian Tian, Ph.D, +86 01082266355, [email protected]
6 Study Locations in 1 Countries
Beijing Municipality
Beijing Obstetrics and Gynecology Hospital,Capital Medical University, Beijing, Beijing Municipality, 100026, China
Xiaokui Yang, Professor, Contact, +86 13552326071, [email protected]
Recruiting
Peking university third hospital, Beijing, Beijing Municipality, 100191, China
Tian Tian, Ph.D, Contact, 010-82266355, [email protected]
Recruiting
Hebei
The second hospital of Hebei Medical University, Shijiazhuang, Hebei, 050061, China
Guimin Hao, Professor, Contact, +86 13623218091, [email protected]
Recruiting
Ningxia
General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China
Junli Zhao, Professor, Contact, +86 15825310348, [email protected]
Recruiting
Shanxi
Tang Du Hospital, Xi’an, Shanxi, 710038, China
Xiaohong Wang, Professor, Contact, +86 18165178306, [email protected]
Recruiting
Shenzhen
Peking University Shenzhen Hospital, Shenzhen, Shenzhen, 518036, China
Xi Xia, Professor, Contact, +86 15989897064, [email protected]
Recruiting