Follicular Fluid, Bioavailable Vitamin D and Embryo Quality Markers
NCT ID: NCT03073720
Last Updated: 2020-03-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
43 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-07-26
Study Completion Date
2019-12-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Vitamin D Deficiency
Study Design
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Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
48 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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ART Fertility Clinics LLC
OTHER
Sponsor Role
lead
Responsible Party
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Prof Dr. Human Fatemi
Medical Director
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Human Fatemi, Medical D.
Role: PRINCIPAL_INVESTIGATOR
ART Fertility Clinics LLC
Locations
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IVI Middle East Fertilty Clinic
Abu Dhabi, , United Arab Emirates
Site Status
Countries
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United Arab Emirates
References
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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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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Diez-Juan A, Rubio C, Marin C, Martinez S, Al-Asmar N, Riboldi M, Diaz-Gimeno P, Valbuena D, Simon C. Mitochondrial DNA content as a viability score in human euploid embryos: less is better. Fertil Steril. 2015 Sep;104(3):534-41.e1. doi: 10.1016/j.fertnstert.2015.05.022. Epub 2015 Jun 11.
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Seli E. Mitochondrial DNA as a biomarker for in-vitro fertilization outcome. Curr Opin Obstet Gynecol. 2016 Jun;28(3):158-63. doi: 10.1097/GCO.0000000000000274.
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Other Identifiers
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1606-ABU-048-HF
Identifier Type: -
Identifier Source: org_study_id
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