Relationship Between Some Vitamins and Antioxidants With in Vitro Fertilization Outcomes

May 23, 2022 updated by: Damascus University

Vitamin D and Some Antioxidants and Trace Elements Levels in Women: Relationship With I.V.F Outcomes

observation of females condition will getting pregnant by undergoing assisted reproductive technologies, the most important of which is the in vitro fertilization (IVF), where blood and follicular fluid samples are collected from them at the same stage of in vitro fertilization, and then monitor the IVF outcomes until pregnancy occurs or not, based on blood tests. The levels of interested markers in blood and follicular fluid samples of the study individuals are assayed in order to compare these levels with the egg criteria such as egg number and maturation rate and finally compare the results with occurrence or absence of pregnancy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Vitamin D, vitamin E, zinc and glutathione peroxidase will be measured in blood and follicular fluid samples of study subjects for women undergoing in vitro fertilization after monitoring their health for two to three months before beginning the first stage of in vitro fertilization. Once start the ovulation induction protocol, which is the first stage of in vitro fertilization, we will monitor all the results from the number of eggs and follicles, their diameter, the thickness of the endometrium, the number of mature eggs, the egg maturation rate and fertilization rate to the occurrence of biochemical pregnancy or not later, based on the blood Human chorionic gonadotropin (hCG) levels two weeks after the embryos transfer to the uterus. The patient is monitored until clinical pregnancy is complete or not. On the other hand, we will later compare the levels of studied parameters with the aforementioned egg quality criteria and with the clinical pregnancy rate of the study group in order to understand the relationship between these studied parameters and the occurrence of pregnancy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

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

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic
        • Damascus University
      • Damascus, Syrian Arab Republic
        • Orient Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females attending Orient Fertility and Genetics Hospital for infertility treatment or pregnancy assistance

Description

Inclusion Criteria:

  • Cases of Healthy women (in terms of reproductive function).
  • Aged between 20-40 years and were close in terms of education, nutrition, and social status.
  • Explicit male factor such as Oligospermia, Azoospermia, Asthenozoospermia, or TESA (Testicular Sperm Aspiration), ensuring that there is no fertility-interfering female factor.
  • Undergoing long Gonadotropin-releasing hormone (GnRH) agonist down-regulation protocol.

Exclusion Criteria:

  • Cases classified by the specialist clinician as a female factor such as PCOs (Polycystic Ovary Syndrome), Uterine Fibroids, Uterine Infections, Uterine Adhesions, and Endometriosis.
  • Compound cases.
  • Sex selection cases.
  • Undergoing short GnRH agonist or antagonist protocol.
  • Women aged under 20 or above 40.
  • Women who took nutritional supplements, for at least two to three months before the egg retrieval procedure.
  • Smokers.
  • Cases with the following medical conditions: Tumors, Diabetes, Multiple sclerosis, Autoimmune Diseases, Liver or Kidney Disorders, Cushing's Syndrome, and women who take chronic medications

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: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Pregnant group
A female is considered pregnant when an explicit gestational sac inside the uterus is seen by ultrasound 4 weeks after embryo transfer.
Drug: human chorionic gonadotropin
10000 IU when at least three follicles become more than 16 mm
Other Names:
  • Chorex
Non-pregnant group
A female is considered not pregnant when no explicit gestational sac is seen inside the uterus by ultrasound 4 weeks after embryo transfer.
Drug: human chorionic gonadotropin
10000 IU when at least three follicles become more than 16 mm
Other Names:
  • Chorex

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood and follicular fluid vitamin D concentrations
Time Frame: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Immediately after oocyte retrieval
Blood and follicular fluid vitamin E concentrations
Time Frame: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Immediately after oocyte retrieval
Blood and follicular fluid zinc concentrations
Time Frame: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Immediately after oocyte retrieval
Blood and follicular fluid glutathione peroxidase concentrations
Time Frame: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Immediately after oocyte retrieval

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of oocytes retrieved
Time Frame: Immediately after oocyte retrieval
The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration after ovulation trigger
Immediately after oocyte retrieval
Number of Metaphase II Oocytes (MII)
Time Frame: Within two hours after oocyte retrieval
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope
Within two hours after oocyte retrieval
Maturation Rate%
Time Frame: Within two hours after oocyte retrieval
Maturation Rate is calculated by dividing the number of mature (MII) oocytes by the number of retrieved oocytes
Within two hours after oocyte retrieval
Fertilization Rate%
Time Frame: 16-18 hours after microinjection
Fertilization Rate is calculated by dividing the number of obtained zygote (2PN) by the number of injected oocytes
16-18 hours after microinjection
Embryo Quality
Time Frame: Day of transfer (2 or 3 days after microinjection)
Embryos are assessed using Nikon SMZ1500 stereoscope
Day of transfer (2 or 3 days after microinjection)
Biochemical Pregnancy Rate%
Time Frame: 2 weeks after embryo transfer
Biochemical pregnancy is defined as a positive serum beta-hCG pregnancy test after 2 weeks of embryo transfer. The biochemical pregnancy rate is calculated by dividing the number of women who are biochemically pregnant by the number of women who have at least 1 embryo transferred
2 weeks after embryo transfer
Clinical Pregnancy Rate% (Per Embryo Transfer)
Time Frame: 4 weeks after embryo transfer
weeks of embryo transfer. The clinical pregnancy rate is calculated as by dividing the number of women who are clinically pregnant divided by the number of women who have at least 1 embryo transferred
4 weeks after embryo transfer

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Damascus University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raghad MH Faisal, MD, Damascus University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UDFP-Biochemistry-01-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The study samples will be collected from female attending Orient Hospital (assisted reproduction and genetics) in order to carry out the in vitro fertilization process after obtaining the approval of the ethical committee of Damascus University, They will be informed with their husbands of the research objectives and sign the approve consent

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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