Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes

Infertility Clinical Trial

Official title:

Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01419743
• Other study ID #: Moy 2011 Vit D
• Status: Terminated
• Phase: Phase 2
• First received: August 16, 2011
• Last updated: February 16, 2014
• Start date: August 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Historically, vitamin D has been considered to play a role solely in bone and calcium metabolism. Numerous studies have suggested a link between vitamin D deficiency and adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. In the obstetrics literature, vitamin D deficiency has been linked to preeclampsia, gestational diabetes, and increased rate of cesarean section rate. Recent data from retrospective chart reviews have demonstrated a possible role of vitamin D in implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization. Patients found to be deficient in vitamin D were found to have significantly lower clinical pregnancy rates when compared to patients who were replete in vitamin D levels. Currently, there are no prospective clinical trials investigating the effects of vitamin D supplementation on IVF outcomes such as clinical pregnancy rate and implantation rates. The investigators hypothesize that the vitamin D supplementation in patients found to be either deficient or insufficient in vitamin D will lead to improved pregnancy rates in infertility patients undergoing in-vitro fertilization.

Description:

The trial will not pay for or subsidize for IVF treatment. Participants will receive blood Vitamin D screening test and any necessary supplements free of charge.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• Infertile women aged = 38 years undergoing fresh invitro fertilization cycles

Exclusion Criteria:

• Infertile women aged > 38 undergoing fresh invitro fertilization cycles

• Patients undergoing frozen embryo transfers

• Patients undergoing donor-egg cycles

• Patients who have a contraindication to receiving Vitamin D (e.g. patients with history of primary hyperparathyroidism, sarcoidosis, tuberculosis, kidney disease, or lymphoma)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility
• Vitamin D Deficiency

Locations

Country	Name	City	State
United States	Northwestern Memorial Faculty Foundation	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (11)

Barrett H, McElduff A. Vitamin D and pregnancy: An old problem revisited. Best Pract Res Clin Endocrinol Metab. 2010 Aug;24(4):527-39. doi: 10.1016/j.beem.2010.05.010. Review. — View Citation

Bodnar LM, Catov JM, Simhan HN, Holick MF, Powers RW, Roberts JM. Maternal vitamin D deficiency increases the risk of preeclampsia. J Clin Endocrinol Metab. 2007 Sep;92(9):3517-22. Epub 2007 May 29. — View Citation

Dobnig H, Pilz S, Scharnagl H, Renner W, Seelhorst U, Wellnitz B, Kinkeldei J, Boehm BO, Weihrauch G, Maerz W. Independent association of low serum 25-hydroxyvitamin d and 1,25-dihydroxyvitamin d levels with all-cause and cardiovascular mortality. Arch Intern Med. 2008 Jun 23;168(12):1340-9. doi: 10.1001/archinte.168.12.1340. — View Citation

Halloran BP, DeLuca HF. Effect of vitamin D deficiency on fertility and reproductive capacity in the female rat. J Nutr. 1980 Aug;110(8):1573-80. — View Citation

Heaney RP. Vitamin D in health and disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1535-41. doi: 10.2215/CJN.01160308. Epub 2008 Jun 4. — View Citation

Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review. — View Citation

Johnson LE, DeLuca HF. Reproductive defects are corrected in vitamin d-deficient female rats fed a high calcium, phosphorus and lactose diet. J Nutr. 2002 Aug;132(8):2270-3. — View Citation

Kinuta K, Tanaka H, Moriwake T, Aya K, Kato S, Seino Y. Vitamin D is an important factor in estrogen biosynthesis of both female and male gonads. Endocrinology. 2000 Apr;141(4):1317-24. — View Citation

Ozkan S, Jindal S, Greenseid K, Shu J, Zeitlian G, Hickmon C, Pal L. Replete vitamin D stores predict reproductive success following in vitro fertilization. Fertil Steril. 2010 Sep;94(4):1314-9. doi: 10.1016/j.fertnstert.2009.05.019. Epub 2009 Jul 8. — View Citation

Pittas AG, Lau J, Hu FB, Dawson-Hughes B. The role of vitamin D and calcium in type 2 diabetes. A systematic review and meta-analysis. J Clin Endocrinol Metab. 2007 Jun;92(6):2017-29. Epub 2007 Mar 27. Review. — View Citation

Trivedi DP, Doll R, Khaw KT. Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial. BMJ. 2003 Mar 1;326(7387):469. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Serum hCG will be drawn per routine IVF protocol (~ 10 days after embryo transfer). Patients will have a repeat bHCG drawn 48hrs if they have a positive result from the first bHCG test. Clinical pregnancy will be defined as ultrasound documentation of fetal heart tones.	assessed at conclusion of the study (~ 1 yr)	No