AzTrials
AzTrials

Vitamin D DeficiencyNCT03073720

Follicular Fluid, Bioavailable Vitamin D and Embryo Quality Markers

An observational study of Vitamin D Deficiency, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine the correlation between bioavailable Vitamin D values and euploid status of the embryos in larger size follicles from UAE women undergoing in vitro fertilization procedures. Read more about this study

Who is it for?
Ages 18 to 48 years, women onlyHealthy volunteers can take part
Conditions the study is for
Vitamin D Deficiency
How many people
43 participants
Where
1 siteUnited Arab Emirates
Study dates
26 Jul 2017to 31 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 48 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: UAE patients with infertility (primary or secondary) and indication for IVF/ICSI treatment with PGS

Who may be able to join

  • Women´s Age >18 - ≤43 years.
  • BMI 19-33
  • Male partner will produce fresh sperm sample on the same day of the egg collection procedure.
  • Women with more than 10 follicles at the time of the trigger
  • At the time of egg retrieval, at least three follicles between 14-<17 mm and three follicles ≥17 mm.
  • Women ≤35 years old stimulation with rFSH antagonist
  • Women ≥36 years old stimulation with highly-purified human menopausal gonadotropins (hpHMG) specifically for the additional LH.
  • Middle East population

Who cannot join

  • Polycystic ovarian syndrome (according to the Rotterdam Criteria).
  • Patients at risk of OHSS, according to the criteria previously described by Papanikolau et al. (23).
  • History of endometriosis, classified according to the American Fertility Society (AFS) as stage 3 or more.
  • Severe male factor definition (<2 million of sperm per ml of ejaculate)
  • Recurrent miscarriage (3 miscarriages)
  • Smokers
  • History of chemotherapy or radiotherapy

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • IVI Middle East Fertilty Clinic

    Abu Dhabi

Other trials in United Arab Emirates

About this study

Official title: Correlation Between Follicular Fluid Levels of Bioavailable Vitamin D and Embryo Quality Markers: Euploid Status, Morphokinetics and Mitochondrial DNA Content Among UAE Women Undergoing an IVF Cycle

To determine the correlation between bioavailable Vitamin D values and euploid status of the embryos in larger size follicles from UAE women undergoing in vitro fertilization procedures.

Read the detailed description

To study the possible correlation between bioavailable vitamin D values in follicular fluid and embryo quality markers.

To correlate bioavailable Vitamin D values in follicular fluid from large size follicles with embryo euploid status as our main objective. Secondly, looking at morphokinetics and mitochondrial content of these embryos.

Taking into account that most of UAE patients have deficiency or insufficiency of Vitamin D, if there is a correlation found we will understand better the underlying mechanism by which bioavailable Vitamin D levels may be affecting embryo quality, therefore IVF outcomes.

Medical subject headings
Vitamin D Deficiency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vitamin D values in follicular fluid and embryo quality markers among UAE women undergoing an IVF cycle

    A correlation between vitamin D levels and embryo development patterns

    Measured: 6-10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2017
  2. Study start26 Jul 2017
  3. Primary completion30 Jul 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03073720
Sponsor's protocol ID
1606-ABU-048-HF
Status last verified
Mar 2020
First submitted
27 Feb 2017
Last updated
6 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 17634462

  • Grober U, Spitz J, Reichrath J, Kisters K, Holick MF. Vitamin D: Update 2013: From rickets prophylaxis to general preventive healthcare. Dermatoendocrinol. 2013 Jun 1;5(3):331-47. doi: 10.4161/derm.26738. Epub 2013 Nov 5.

    PubMed 24516687

  • Anagnostis P, Karras S, Goulis DG. Vitamin D in human reproduction: a narrative review. Int J Clin Pract. 2013 Mar;67(3):225-35. doi: 10.1111/ijcp.12031. Epub 2013 Jan 7.

    PubMed 23294318

  • Coney P, Demers LM, Dodson WC, Kunselman AR, Ladson G, Legro RS. Determination of vitamin D in relation to body mass index and race in a defined population of black and white women. Int J Gynaecol Obstet. 2012 Oct;119(1):21-5. doi: 10.1016/j.ijgo.2012.05.024. Epub 2012 Jul 18.

    PubMed 22818533

  • Irani M, Minkoff H, Seifer DB, Merhi Z. Vitamin D increases serum levels of the soluble receptor for advanced glycation end products in women with PCOS. J Clin Endocrinol Metab. 2014 May;99(5):E886-90. doi: 10.1210/jc.2013-4374. Epub 2014 Feb 27.

    PubMed 24606102

  • Hussain AN, Alkhenizan AH, El Shaker M, Raef H, Gabr A. Increasing trends and significance of hypovitaminosis D: a population-based study in the Kingdom of Saudi Arabia. Arch Osteoporos. 2014;9:190. doi: 10.1007/s11657-014-0190-3. Epub 2014 Sep 12.

    PubMed 25213798

  • Farzadi L, Khayatzadeh Bidgoli H, Ghojazadeh M, Bahrami Z, Fattahi A, Latifi Z, Shahnazi V, Nouri M. Correlation between follicular fluid 25-OH vitamin D and assisted reproductive outcomes. Iran J Reprod Med. 2015 Jun;13(6):361-6.

    PubMed 26330851

  • Parikh G, Varadinova M, Suwandhi P, Araki T, Rosenwaks Z, Poretsky L, Seto-Young D. Vitamin D regulates steroidogenesis and insulin-like growth factor binding protein-1 (IGFBP-1) production in human ovarian cells. Horm Metab Res. 2010 Sep;42(10):754-7. doi: 10.1055/s-0030-1262837. Epub 2010 Aug 13.

    PubMed 20711952

  • 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.

    PubMed 19589516

  • Anifandis GM, Dafopoulos K, Messini CI, Chalvatzas N, Liakos N, Pournaras S, Messinis IE. Prognostic value of follicular fluid 25-OH vitamin D and glucose levels in the IVF outcome. Reprod Biol Endocrinol. 2010 Jul 28;8:91. doi: 10.1186/1477-7827-8-91.

    PubMed 20667111

  • Rudick B, Ingles S, Chung K, Stanczyk F, Paulson R, Bendikson K. Characterizing the influence of vitamin D levels on IVF outcomes. Hum Reprod. 2012 Nov;27(11):3321-7. doi: 10.1093/humrep/des280. Epub 2012 Aug 21.

    PubMed 22914766

  • 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.

    PubMed 25265402

  • Bikle DD, Gee E, Halloran B, Kowalski MA, Ryzen E, Haddad JG. Assessment of the free fraction of 25-hydroxyvitamin D in serum and its regulation by albumin and the vitamin D-binding protein. J Clin Endocrinol Metab. 1986 Oct;63(4):954-9. doi: 10.1210/jcem-63-4-954.

    PubMed 3745408

  • Powe CE, Evans MK, Wenger J, Zonderman AB, Berg AH, Nalls M, Tamez H, Zhang D, Bhan I, Karumanchi SA, Powe NR, Thadhani R. Vitamin D-binding protein and vitamin D status of black Americans and white Americans. N Engl J Med. 2013 Nov 21;369(21):1991-2000. doi: 10.1056/NEJMoa1306357.

    PubMed 24256378

  • Engelman CD, Fingerlin TE, Langefeld CD, Hicks PJ, Rich SS, Wagenknecht LE, Bowden DW, Norris JM. Genetic and environmental determinants of 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D levels in Hispanic and African Americans. J Clin Endocrinol Metab. 2008 Sep;93(9):3381-8. doi: 10.1210/jc.2007-2702. Epub 2008 Jul 1.

    PubMed 18593774

Questions about this trial

What is this clinical trial studying?

An observational study of Vitamin D Deficiency, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vitamin D values in follicular fluid and embryo quality markers among UAE women undergoing an IVF cycle (time frame: 6-10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03073720, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.

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