Clinical trial NCT03804294: Effect of Vitamin D on Outcome of Assisted Reproductive Technology(ART);
Official title: Effect of Vitamin D on Outcome of Assisted Reproductive Technology(ART)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ART
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infertile couples

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.

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.

Primary outcomes:
measure: clinical pregnancy rates
timeFrame: 12 weeks after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: XU ZHI
role: STUDY_CHAIR
References:
citation: 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.