The Effect of Vitamin D on in Vitro Fertilization Outcome

in Vitro Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361827
• Other study ID #: RMCZZU-Vitamin D
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2023
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 688
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• in Vitro Fertilization
• Ongoing Pregnancy Rate
• Vitamin D

Intervention

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.

Locations

Country	Name	City	State
China	Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University	Luoyang maternal and child hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	12 weeks after embryo transfer, gestational sac with fetal heart present inside uterus	12 weeks after embryo transfer
Secondary	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