The Effect of Vitamin D on in Vitro Fertilization Outcome

NCT ID: NCT02361827

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

688 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Ongoing Pregnancy Rate Vitamin D In Vitro Fertilization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A1, Vitamin D deficient

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

Embryo transfer

Intervention Type PROCEDURE

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

Embryo transfer

Intervention Type PROCEDURE

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

Embryo transfer

Intervention Type PROCEDURE

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)

Embryo transfer

Intervention Type PROCEDURE

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)

Embryo transfer

Intervention Type PROCEDURE

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)

Embryo transfer

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Luoyang maternal and child hospital

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Yingpu Sun

Director of Reproductive Medicine Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiqin Bu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Locations

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Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 39829955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25265402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25256926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25121462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24210230 (View on PubMed)

Other Identifiers

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RMCZZU-Vitamin D

Identifier Type: -

Identifier Source: org_study_id

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