Clinical trial NCT03073720: Follicular Fluid, Bioavailable Vitamin D and Embryo Quality Markers
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UAE patients with infertility (primary or secondary) and indication for IVF/ICSI treatment with PGS

Brief 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.

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Vitamin D values in follicular fluid and embryo quality markers among UAE women undergoing an IVF cycle
timeFrame: 6-10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: IVI Middle East Fertilty Clinic
Study officials:
affiliation: ART Fertility Clinics LLC
name: Human Fatemi, Medical D.
role: PRINCIPAL_INVESTIGATOR
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