NCT03804294

Brief Summary

Vitamin D has many biological functions. Vitamin D receptors are widely distributed in the male and female reproductive system. Animal experiments have shown that vitamin D deficiency can affect hormone synthesis and gamete formation, reduce sperm motility, and may be related to diseases such as PCOS and endometriosis. Population studies suggest that vitamin D may be related to androgen levels and sperm quality, but whether vitamin D affects the outcome of assisted reproduction is controversial and inconclusive. This study intends to explore whether vitamin D affects the outcome of assisted reproduction through a large sample cohort study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

January 11, 2019

Last Update Submit

January 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rates

    Time Frame: the presence of an intrauterinesac with an embryonic pole demonstrating cardiacactivity

    12 weeks after transplantation

Study Arms (1)

vitamin D-ART

Infertile couples who undergo their first IVF/ICSI and IUI cycle in Reproductive Medicin Center of Peking university Third Hosiptal.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

infertile couples

You may qualify if:

  • infertile couples who undergo their first IVF/ICSI and IUI cycle at Reproductive Medicine Center of Peking University Third Hospital.

You may not qualify if:

  • refusing to be recruited.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100091, China

RECRUITING

Related Publications (1)

  • Chen Y, Liu D, Zeng L, Xu H, Jiang H, Yang R, Wang H, Yan L, Li R, Qiao J, Zhi X. Effect of serum 25-hydroxyvitamin D levels on sperm quality and assisted reproductive technology outcomes for men of infertile Chinese couples. Andrology. 2020 Sep;8(5):1277-1286. doi: 10.1111/andr.12818. Epub 2020 Jun 3.

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Officials

  • XU ZHI

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

XU ZHI, doctor

CONTACT

yilu chen, bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 15, 2019

Study Start

November 28, 2018

Primary Completion

December 1, 2019

Study Completion

July 1, 2020

Last Updated

January 17, 2019

Record last verified: 2019-01

Locations