Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes
16. februar 2014 opdateret af: Irene Moy, Northwestern University
Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
102
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern Memorial Hospital
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University Feinberg School of Medicine
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern Memorial Faculty Foundation
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 38 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Infertile women aged ≤ 38 years undergoing fresh in-vitro fertilization cycles
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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patients with Vit D level of < 20ng/mL: Group 1
randomized to receive 400 IU of vitamin D per day
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patients with Vit D levels <20ng/mL: Group 2
Randomized to receive 2000IU of Vitamin D per day
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patients with vit D levels between 20-30 ng/mL: Group 3
Randomized to receiving placebo
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patients with vit D levels between 20-30 ng/mL: Group 4
Randomized to receive 400IU of vitamin D per day
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patients with vit D levels between 20-30 ng/mL: Group 5
Randomized to receive 2000IU of vitamin D per day
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patients with vit D levels > 30ng/mL: Group 6
No treatment
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical pregnancy rate
Tidsramme: assessed at conclusion of the study (~ 1 yr)
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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.
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assessed at conclusion of the study (~ 1 yr)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ralph Kazer, MD, Northwestern Memorial Faculty Foundation
- Studiestol: Irene Moy, MD, Northwestern University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2011
Primær færdiggørelse (Faktiske)
1. januar 2014
Studieafslutning (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først indsendt
16. august 2011
Først indsendt, der opfyldte QC-kriterier
17. august 2011
Først opslået (Skøn)
18. august 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. februar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. februar 2014
Sidst verificeret
1. februar 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Moy 2011 Vit D
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .