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Polycystic Ovary SyndromeNCT04082650

Vitamin D and Pregnancy Outcome in PCOS Patients

A study testing vitamin D in people with Polycystic Ovary Syndrome and in Vitro Fertilization, run by Women's Hospital School Of Medicine Zhejiang University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multicenter double-blinded placebo-controlled randomised trial aims to evaluate the effectiveness of vitamin D supplementation prior to IVF on the live birth rate in women with PCOS. Women with PCOS scheduled for IVF will be enrolled. Read more about this study

Who is it for?
Ages 20 to 42 years, women only
What is being tested?
vitamin D
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
876 participants
Where
2 sitesChina
Study dates
15 Oct 2020to 27 Jan 2025
Phase
Interventional
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 20 to 42 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women aged 20 to 42 years old;
  • Diagnosed with PCOS (Rotterdam Criteria);
  • Scheduled for IVF;
  • Written informed consent.

Who cannot join

  • Women who had three or more failed IVF cycles;
  • Women scheduled for preimplantation genetic testing;
  • Known Vitamin D allergy;
  • Women with a history of chronic absorption syndrome or bile dysplasia, or parathyroid dysfunction, or kidney stones, or blood Calcium ion concentration greater than 2.6mmol/L (normal value 2.25 - 2.75mmol/L (9 to 11mg/dl), or hyperphosphataemia (1.61mmol/L), or metabolic-related bone disease, or chronic diseases that may cause bone abnormalities (liver and kidney insufficiency);
  • Women receiving treatments for tuberculosis, convulsions, and epilepsy because medications treating these diseases may affect the metabolism of vitamin D.
  • Women undergoing an IVF treatment with donor oocytes.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • Women's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: Vitamin D Supplementation Prior to in Vitro Fertilization in Women With Polycystic Ovary Syndrome: a Protocol of a Multicenter Randomised Double-blind Placebo-controlled Clinical Trial

This multicenter double-blinded placebo-controlled randomised trial aims to evaluate the effectiveness of vitamin D supplementation prior to IVF on the live birth rate in women with PCOS. Women with PCOS scheduled for IVF will be enrolled. Eligible participants will be randomised 1:1 to receive oral capsules of 4000IU vitamin D per day or placebo for around 12 weeks until the day of triggering.

Read the detailed description

Polycystic ovary syndrome (PCOS) is one of the leading causes of female infertility, affecting around 5% of women with a child-bearing age in China. Vitamin D insufficiency is common in women with PCOS and is associated with lower live birth rates in these women. However, evidence regarding the effectiveness of vitamin D treatment in women with PCOS is inconclusive. This multicenter double-blinded placebo-controlled randomised trial aims to evaluate the effectiveness of vitamin D supplementation prior to IVF on the live birth rate in women with PCOS.

The investigators plan to enroll women with PCOS scheduled for IVF. Eligible participants will be randomised 1:1 to receive oral capsules of 4000IU vitamin D per day or placebo for around 12 weeks until the day of triggering. All IVF procedures will be carried out following a routine method in each center. Women will be followed up until six months after randomisation for those who fail to get pregnant after the completion of the first embryo transfer or delivery for those who get pregnant after the first embryo transfer. The primary outcome is live birth after the first embryo transfer. Primary analysis will be by intention-to-treat analysis. The investigators plan to recruit 860 women to demonstrate women treated with vitamin D have a higher live birth rate than those treated with placebo (48% versus 38%), accounting for 10% loss to follow-up with a significance level at 0.05 and a power of 80%.

Being tested
vitamin D, Placebo
Keywords
Polycystic Ovary Syndrome, in vitro fertilization, Vitamin D, randomized trial
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

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

  • vitamin DDrug

    Also called non

    4000IU per day

  • PlaceboOther

    The same doses with vitamin D

Study groups in NCT04082650
Study groupRoleWhat they receive
Vitamin DExperimentalParticipants in the intervention group will be treated with vitamin D 4000IU (800IU per pill, take five pills once each day) per day for around 12 weeks (till the triggering day).
Receives: Drug: vitamin D
PlaceboPlacebo comparatorParticipants in the control group will be treated with equal amount of placebo tablets per day for the same duration.
Receives: Other: Placebo

What is being measured

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

  1. Number of Participants with live birth

    The primary outcome is live birth after the first embryo transfer. Live birth is defined as the delivery of at least one baby after 24 weeks of gestation that exhibits any sign of life.

    Measured: 1 day after delivery

Secondary outcomes (20)

  1. Number of Participants with Cumulative live birth

    Cumulative live birth: defined as live birth resulting from pregnancies that occur within 6 months after randomization.

    Measured: 6 months after randomization of the last participant

  2. Number of Participants with Clinical pregnancy

    Clinical pregnancy: defined as at least one gestational sac on ultrasound at around 7 weeks' gestation with the detection of heart beat activity after the completion of the first embryo transfer;

    Measured: 4 weeks after embryo transfer

  3. birth weight

    Weight of newborns at delivery.

    Measured: The day of delivery

  4. Number of Participants with miscarriage

    miscarriage was defined as a positive pregnancy test but no detectable heart rate before 24 weeks' gestation after the completion of the first transfer;

    Measured: 24 gestational weeks in maximum

  5. Number of Participants with Ongoing pregnancy

    defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond after the completion of the first transfer

    Measured: at 12 weeks' gestation

  6. Number of Participants with Biochemical pregnancy

    defined with a positive pregnancy test

    Measured: 2 weeks after embryo transfer

  7. Number of Participants with Ectopic pregnancy

    defined as embryo implanted at any site other than the endometrial lining of the uterus cavity after the completion of the first transfer

    Measured: 4 weeks after embryo transfer

  8. Number of Participants with Ovarian hyperstimulation syndrome

    defined according to the Golan criteria. Moderate OHSS is diagnosed by the presence of ascites on ultrasonography in addition to abdominal distension and discomfort with or without nausea, vomiting and/or diarrhea. Severe OHSS is diagnosed when there is clinical evidence of ascites and/or hydrothorax or breathing difficulties with or without hemoconcentration, coagulation abnormalities and diminished renal function.

    Measured: From the day of oocyte retrieval to two weeks after embryo transfer

  9. Number of available embryos for transfer

    non

    Measured: 5 days after oocyte retrieval

  10. Number of Participants with Pre-eclampsia

    defined as the development of gestational hypertension with proteinuria (≥300 mg/24-hour urine collection or 30 mg/dL in single urine sample) of new onset after 20 weeks of gestation after the completion of the first transfer

    Measured: 20 weeks of gestation till delivery

  11. Number of Participants with Gestational hypertension

    defined as the development of blood pressure greater than 140/90 mmHg after pregnancy without proteinuria or other signs of preeclampsia after the completion of the first transfer;

    Measured: 20 weeks of gestation till delivery

  12. Number of Participants with Premature rupture of membrane

    PROM was defined as rupture of the amniotic membranes before the onset of labor including PROM at term and preterm PROM.

    Measured: The day of delivery

  13. Number of Participants with Postpartum hemorrhage

    defined as the loss of 500 ml of blood or more after completion of the third stage of labor after the completion of the first transfer

    Measured: 1 day after delivery

  14. Number of Participants with Preterm delivery

    Defined as delivery of a fetus at less than 37 and more than 28 weeks' gestational age after the completion of the first transfer

    Measured: 1 day after delivery

  15. Number of Participants with Gestational diabetes mellitus

    defined as carbohydrate intolerance of variable severity with onset or first recognition during pregnancy as determined from the diagnosis in the obstetrical medical record

    Measured: Up to ten months once the participants get pregnancy

  16. Number of Participants with Placenta previa

    defined as a placenta that is implanted over or very close to the internal cervical orifice

    Measured: after 24 weeks of gestation

  17. Number of Participants with Stillbirth

    defined as the absence of signs of life at or after birth after the completion of the first transfer

    Measured: 1 day after delivery

  18. Apgar score

    non

    Measured: 1 minute or 5 minutes after delivery

  19. Serum Vitamin D binding protein, glucose, insulin, Calcium ion concentration

    non

    Measured: The day of oocyte retrieval

  20. Serum vitamin levels

    Serum vitamin levels at the triggering day

    Measured: One day before oocyte retrieval

Timeline

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

  1. First posted9 Sep 2019
  2. Study start15 Oct 2020
  3. Primary completion23 May 2024
  4. Study completion27 Jan 2025

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
876 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04082650
Sponsor's protocol ID
VDPI
Status last verified
Jan 2025
First submitted
4 Sep 2019
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All data relevant to the study will be generated in the article or uploaded as supplementary information. Deidentified participant data will be available from Dr. Dan Zhang (zhangdan@zju.edu.cn) on a reasonable request. Protocols and statistical analysis plans will be included as supplementary information.

Publications

  • Hu KL, Liao T, Wu Q, Ma X, Cao Y, Tan J, Tian L, Wang J, Yin J, Liu Y, Zhao J, Zhao S, Li M, Cai L, Liu FT, Gan K, Xu Y, Wang Y, Cai J, Zheng B, Ma Y, Ma Q, Zheng J, Pu X, Zhang H, Hao C, Xie Q, Zhang C, Jiang L, Zhang S, Yan L, Meng Q, Li W, Mol BW, Li R, Wang R, Zhang D; VitD-PCOS trial group. Vitamin D supplementation before in vitro fertilisation in women with polycystic ovary syndrome: multicentre, double blind, placebo controlled, randomised clinical trial. BMJ. 2026 Feb 17;392:e087438. doi: 10.1136/bmj-2025-087438.

    PubMed 41702641

  • Hu KL, Gan K, Wang R, Li W, Wu Q, Zheng B, Zou L, Zhang S, Liu Y, Wu Y, Chen R, Cao W, Yang S, Liu FT, Tian L, Zeng H, Xu H, Qiu S, Yang L, Chen X, Pan X, Wu X, Mol BW, Li R, Zhang D. Vitamin D supplementation prior to in vitro fertilisation in women with polycystic ovary syndrome: a protocol of a multicentre randomised, double-blind, placebo-controlled clinical trial. BMJ Open. 2020 Dec 8;10(12):e041409. doi: 10.1136/bmjopen-2020-041409.

    PubMed 33293396

Questions about this trial

What is this clinical trial studying?

A study testing vitamin D in people with Polycystic Ovary Syndrome and in Vitro Fertilization, run by Women's Hospital School Of Medicine Zhejiang University at 2 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?

The sponsor lists 4 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with live birth (time frame: 1 day after delivery). 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 NCT04082650, which also lists 2 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 29 Jan 2025.

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