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Completed

NCT Number: NCT03073720

Follicular Fluid, Bioavailable Vitamin D and Embryo Quality Markers

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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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

IVI Middle East Fertilty Clinic

Abu Dhabi, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 6-10 months

    A correlation between vitamin D levels and embryo development patterns

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2017
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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