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

NCT01419743 | Terminated

• 1 other identifier: Moy 2011 Vit D
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Infertility; Vitamin D Deficiency

Keywords

Vitamin D deficiency; Supplementation; Infertility; Clinical pregnancy rates

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (6)

patients with Vit D level of < 20ng/mL: Group 1

randomized to receive 400 IU of vitamin D per day

patients with Vit D levels <20ng/mL: Group 2

Randomized to receive 2000IU of Vitamin D per day

patients with vit D levels between 20-30 ng/mL: Group 3

Randomized to receiving placebo

patients with vit D levels between 20-30 ng/mL: Group 4

Randomized to receive 400IU of vitamin D per day

patients with vit D levels between 20-30 ng/mL: Group 5

Randomized to receive 2000IU of vitamin D per day

patients with vit D levels > 30ng/mL: Group 6

No treatment

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infertile women aged ≤ 38 years undergoing fresh in-vitro fertilization cycles

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (3)

Northwestern Memorial Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (11)

• 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):1314-1319. doi: 10.1016/j.fertnstert.2009.05.019. Epub 2009 Jul 8.

  PMID: 19589516 BACKGROUND

• Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

  PMID: 17634462 BACKGROUND

• 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.

  PMID: 20832734 BACKGROUND

• 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.

  PMID: 18525006 BACKGROUND

• 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. doi: 10.1093/jn/132.8.2270.

  PMID: 12163674 BACKGROUND

• 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. doi: 10.1210/endo.141.4.7403.

  PMID: 10746634 BACKGROUND

• 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. doi: 10.1093/jn/110.8.1573.

  PMID: 7400847 BACKGROUND

• 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. doi: 10.1136/bmj.326.7387.469.

  PMID: 12609940 BACKGROUND

• 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. doi: 10.1210/jc.2007-0298. Epub 2007 Mar 27.

  PMID: 17389701 BACKGROUND

• 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.

  PMID: 18574092 BACKGROUND

• 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. doi: 10.1210/jc.2007-0718. Epub 2007 May 29.

  PMID: 17535985 BACKGROUND

MeSH Terms

Conditions

Infertility; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Ralph Kazer, MD

  Northwestern Memorial Faculty Foundation

  PRINCIPAL INVESTIGATOR

• Irene Moy, MD

  Northwestern University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 18, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

US (3)