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

ART Clinical Trial

— ART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03804294
• Other study ID #: Vitamin D and ART
• Status: Recruiting
• Start date: November 28, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: January 2019
• Source: Peking University Third Hospital
• Contact: XU ZHI, doctor
• Phone: 01082266757
• Email: zhixujp[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: July 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

refusing to be recruited.

Related Conditions & MeSH terms

• ART

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

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