Follicular Fluid, Bioavailable Vitamin D and Embryo Quality Markers

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073720
• Other study ID #: 1606-ABU-048-HF
• Status: Completed
• Start date: July 26, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: IVI Middle East Fertility Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 31, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Locations

Country	Name	City	State
United Arab Emirates	IVI Middle East Fertilty Clinic	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
IVI Middle East Fertility Clinic

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6-10 months