Follicular Fluid, Bioavailable Vitamin D and Embryo Quality Markers

Completed

• Conditions: Vitamin D Deficiency

• Registration Number: NCT03073720
• Lead Sponsor: ART Fertility Clinics LLC

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.

Study Timeline

• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Study Start: 2017-07-26
• Primary Completion: 2019-07-30
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitamin D values in follicular fluid and embryo quality markers among UAE women undergoing an IVF cycle	6-10 months	A correlation between vitamin D levels and embryo development patterns

Trial Locations

Locations (1)

IVI Middle East Fertilty Clinic; 🇦🇪 Abu Dhabi, United Arab Emirates