Follicular Fluid, Bioavailable Vitamin D and Embryo Quality Markers

March 5, 2020 updated by: Prof Dr. Human Fatemi, ART Fertility Clinics LLC

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

UAE patients with infertility (primary or secondary) and indication for IVF/ICSI treatment with PGS

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Human Fatemi, Medical D., ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2017

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

March 2, 2017

First Posted (Actual)

March 8, 2017

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1606-ABU-048-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Deficiency

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe