NCT02361827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
688

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
2.9 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 5, 2025

Status Verified

March 1, 2025

Enrollment Period

4.7 years

First QC Date

February 8, 2015

Last Update Submit

March 2, 2025

Conditions

Ongoing Pregnancy RateVitamin DIn Vitro Fertilization

Keywords

Vitamin DIVF outcome

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    12 weeks after embryo transfer, gestational sac with fetal heart present inside uterus

    12 weeks after embryo transfer

Secondary Outcomes (1)

  • Ectopic pregnancy rate

    35 days after embryo transfer

Study Arms (6)

A1, Vitamin D deficient

Vitamin D level before cycle \< 20 ng/mL.

Procedure: Embryo transfer

B1, Vitamin D insufficient

Vitamin D level before cycle 20-29.9 ng/mL

Procedure: Embryo transfer

C1, Vitamin D replete

Vitamin D level before cycle \> 30 ng/mL

Procedure: Embryo transfer

A2, Vitamin D deficient

Vitamin D level before ET \< 20 ng/mL (FET with Euploid embryos)

Procedure: Embryo transfer

B2, Vitamin D insufficient

Vitamin D level before ET 20-29.9 ng/mL (FET with Euploid embryos)

Procedure: Embryo transfer

C2, Vitamin D replete

Vitamin D level before ET \> 30 ng/mL (FET with Euploid embryos)

Procedure: Embryo transfer

Interventions

Embryo transferPROCEDURE

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.

A1, Vitamin D deficientA2, Vitamin D deficientB1, Vitamin D insufficientB2, Vitamin D insufficientC1, Vitamin D repleteC2, Vitamin D replete

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Important data missing
  • Gametes donation cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Related Publications (5)

  • 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.

    PMID: 39829955BACKGROUND

  • 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.

    PMID: 25265402BACKGROUND

  • 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.

    PMID: 25256926BACKGROUND

  • 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.

    PMID: 25121462BACKGROUND

  • 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.

    PMID: 24210230BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum/follicle fluid

MeSH Terms

Interventions

Embryo Transfer

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Zhiqin Bu, MD, PhD

    Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Reproductive Medicine Center

Study Record Dates

First Submitted

February 8, 2015

First Posted

February 12, 2015

Study Start

January 1, 2018

Primary Completion

September 1, 2022

Study Completion

December 1, 2024

Last Updated

March 5, 2025

Record last verified: 2025-03

Locations

CN(1)