Effect of Vitamin D on Outcome of Assisted Reproductive T... | NCT03804294

Studies
Effect of Vitamin D on Outcome of Assisted Reproductive Technology(ART);

NCT03804294

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Jan 17, 2019Actual

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 28, 2018Actual

Primary Completion Date

Dec 1, 2019Estimated

Completion Date

Jul 1, 2020Estimated

First Submitted Date

Jan 11, 2019

First Submission Date that Met QC Criteria

Jan 11, 2019

First Posted Date

Jan 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2019

Last Update Posted Date

Jan 17, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhi Xu, associate professor, Peking University Third HospitalPrincipal Investigator

Lead Sponsor

Peking University Third HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Vitamin D plays an important role in reproduction, while there is high prevalence of vitamin D deficiency. Serum 25(OH)D was categorized according to clinically accepted ranges for vitamin D deﬁciency (<20 ng/mL), insufﬁciency (20-30 ng/mL), and replete (>30 ng/mL).

This is a retrospective cohort study of about 2000 infertile couples who undergo their ﬁrst IVF/ICSI and IUI cycle at Reproductive Medicine Center of Peking University Third Hospital. Patients will be excluded if they refuse to be recruited. Serum samples are collected the day when patients first time to Reproductive Medicine Center and were stored at -20℃ until assayed. Life style of patients is collected by questionair. Vitamin D status is measured by assessing circulating levels of 25(OH)D in frozen, never previously thawed serum samples using radioimmunoassay.

The investigators will comapere the ART outcomes in different groups according to serum 25(OH)D status.

In female, the primary outcome is clinical pregnancy rates deﬁned as the presence of an intrauterinesac with an embryonic pole demonstrating cardiacactivity at 7 weeks of gestation. Secondary outcomes are quality of embryo, positive hCG rates and live birth rates.

In male, the primary outcome is semen quality, such as semen volume, sperm concentration, sperm motility, morphologically normal percent and progressive motile spermatozoa percent. Secondary outcomes are clinical pregnancy rates and live birth rates.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitamin D-ART		Infertile couples who undergo their ﬁrst IVF/ICSI and IUI cycle in Reproductive Medicin Center of Peking university Third Hosiptal.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical pregnancy rates	Time Frame: the presence of an intrauterinesac with an embryonic pole demonstrating cardiacactivity	12 weeks after transplantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

refusing to be recruited.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

infertile couples

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
XU ZHI, doctor	Contact	01082266757	01082266757	zhixujp@163.com
yilu chen, bachelor	Contact	8601082266752	01082266757	yilua_chen@163.com

Overall Officials

Name	Affiliation	Role
XU ZHI	Peking University Third Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital	Recruiting	Beijing	Beijing Municipality	100091	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32412142	Derived	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.