The Effect of Vitamin D on in Vitro Fertilization Outcome

The Effect of Vitamin D on in Vitro Fertilization Outcome, a Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: in Vitro Fertilization; Vitamin D; Ongoing Pregnancy Rate
• Intervention / Treatment: Procedure: Embryo transfer

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.

• Study Type: Observational
• Enrollment (Actual): 688

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients whose IVF cycles were cancelled due to ovarian hyperstimulation syndrome were also excluded);.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A1, Vitamin D deficient; Vitamin D level before cycle < 20 ng/mL.	Procedure: Embryo transfer; For patients in each group after oocyte retrieval, they will have embryo transferred 3 or 5 days after oocyte retrieval. For FET cycles, they will have ET with an euploid blastocyst.
B1, Vitamin D insufficient; Vitamin D level before cycle 20-29.9 ng/mL	Procedure: Embryo transfer; For patients in each group after oocyte retrieval, they will have embryo transferred 3 or 5 days after oocyte retrieval. For FET cycles, they will have ET with an euploid blastocyst.
C1, Vitamin D replete; Vitamin D level before cycle > 30 ng/mL	Procedure: Embryo transfer; For patients in each group after oocyte retrieval, they will have embryo transferred 3 or 5 days after oocyte retrieval. For FET cycles, they will have ET with an euploid blastocyst.
A2, Vitamin D deficient; Vitamin D level before ET < 20 ng/mL (FET with Euploid embryos)	Procedure: Embryo transfer; For patients in each group after oocyte retrieval, they will have embryo transferred 3 or 5 days after oocyte retrieval. For FET cycles, they will have ET with an euploid blastocyst.
B2, Vitamin D insufficient; Vitamin D level before ET 20-29.9 ng/mL (FET with Euploid embryos)	Procedure: Embryo transfer; For patients in each group after oocyte retrieval, they will have embryo transferred 3 or 5 days after oocyte retrieval. For FET cycles, they will have ET with an euploid blastocyst.
C2, Vitamin D replete; Vitamin D level before ET > 30 ng/mL (FET with Euploid embryos)	Procedure: Embryo transfer; For patients in each group after oocyte retrieval, they will have embryo transferred 3 or 5 days after oocyte retrieval. For FET cycles, they will have ET with an euploid blastocyst.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing pregnancy rate	12 weeks after embryo transfer, gestational sac with fetal heart present inside uterus	12 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ectopic pregnancy rate	Ectopic pregnancy is defined as serum HCG positive, yet with no gestational sac present inside uterine cavity	35 days after embryo transfer

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborators: Luoyang maternal and child hospital
• Investigators: Principal Investigator: Zhiqin Bu, MD, PhD, Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: February 8, 2015
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimated): February 12, 2015

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin D; IVF outcome
• Other Study ID Numbers: RMCZZU-Vitamin D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No