Clinical trial NCT02361827: The Effect of Vitamin D on in Vitro Fertilization Outcome
Official title: The Effect of Vitamin D on in Vitro Fertilization Outcome, a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ongoing Pregnancy Rate
Vitamin D
In Vitro Fertilization
Keywords: Vitamin D
IVF outcome
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Luoyang maternal and child hospital
First posted: 2015-02-12
Enrollment: 688
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients whose IVF cycles were cancelled due to ovarian hyperstimulation syndrome were also excluded);.

Brief summary: To date, several studies have been done to explore the relationship between Vitamin D level and IVF outcome; however, the results are controversial. Sample sizes in these studies mentioned above were relatively small. In addition, there are no prospective cohort studies in this field. Thus, here the investigators carry this prospective observational cohort study to demonstrate the relationship between vitamin D level and IVF outcome.

Detailed description: Vitamin D level is measured before the commence of IVF cycle. According to Vitamin D level, patients are divided into 3 groups: A, Deficient, \<20 ng/mL; B, Insufficient, 20-29.9 ng/mL; C, Replete, \>30 ng/mL.

Ongoing pregnancy rate are compared among these three groups after controlling age, number of embryos transferred, ect.

In addition, Vitamin D level is also meassured before embryo transfer in FET cycles with PGT treatment. The effect of Vitamin D on IVF outcome is detected in patients transferred with Euploid embryos.

Eligibility criteria: Inclusion Criteria:

1. age between 21-40 years old
2. basal FSH hormone level less than 10 mIU/mL
3. the first cycle of IVF treatment with standard long protocol
4. both ovarian present and normal uterus.

Exclusion Criteria:

1. Important data missing
2. Gametes donation cycles
3. Anyone that does not meet the inclusion criteria

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 12 weeks after embryo transfer
Secondary outcomes:
measure: Ectopic pregnancy rate
timeFrame: 35 days after embryo transfer
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
name: Zhiqin Bu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang K, Dong F, Ma S, Bu Z. The association between Vitamin D deficiency and clinical pregnancy rate in IVF patients with different age. Front Endocrinol (Lausanne). 2025 Jan 3;15:1485238. doi: 10.3389/fendo.2024.1485238. eCollection 2024.
citation: Franasiak JM, Molinaro TA, Dubell EK, Scott KL, Ruiz AR, Forman EJ, Werner MD, Hong KH, Scott RT Jr. Vitamin D levels do not affect IVF outcomes following the transfer of euploid blastocysts. Am J Obstet Gynecol. 2015 Mar;212(3):315.e1-6. doi: 10.1016/j.ajog.2014.09.029. Epub 2014 Oct 11.
citation: Fabris A, Pacheco A, Cruz M, Puente JM, Fatemi H, Garcia-Velasco JA. Impact of circulating levels of total and bioavailable serum vitamin D on pregnancy rate in egg donation recipients. Fertil Steril. 2014 Dec;102(6):1608-12. doi: 10.1016/j.fertnstert.2014.08.030. Epub 2014 Sep 23.
citation: Paffoni A, Ferrari S, Vigano P, Pagliardini L, Papaleo E, Candiani M, Tirelli A, Fedele L, Somigliana E. Vitamin D deficiency and infertility: insights from in vitro fertilization cycles. J Clin Endocrinol Metab. 2014 Nov;99(11):E2372-6. doi: 10.1210/jc.2014-1802. Epub 2014 Aug 14.
citation: Rudick BJ, Ingles SA, Chung K, Stanczyk FZ, Paulson RJ, Bendikson KA. Influence of vitamin D levels on in vitro fertilization outcomes in donor-recipient cycles. Fertil Steril. 2014 Feb;101(2):447-52. doi: 10.1016/j.fertnstert.2013.10.008. Epub 2013 Nov 5.