Relationship Between Some Vitamins and Antioxidants With in Vitro Fertilization Outcomes

Sponsor
Damascus University (Other)
Overall Status
Completed
CT.gov ID
NCT05393011
Collaborator
(none)
60
2
47.8
30
0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: human chorionic gonadotropin

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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Vitamin D and Some Antioxidants and Trace Elements Levels in Women: Relationship With I.V.F Outcomes
Actual Study Start Date :
Aug 20, 2017
Actual Primary Completion Date :
Aug 2, 2020
Actual Study Completion Date :
Aug 15, 2021

Arms and Interventions

Arm Intervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. Blood and follicular fluid vitamin D concentrations [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

    2. Blood and follicular fluid vitamin E concentrations [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

    3. Blood and follicular fluid zinc concentrations [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

    4. Blood and follicular fluid glutathione peroxidase concentrations [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

    Secondary Outcome Measures

    1. Number of oocytes retrieved [Immediately after oocyte retrieval]

      The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration after ovulation trigger

    2. Number of Metaphase II Oocytes (MII) [Within two hours after oocyte retrieval]

      The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope

    3. Maturation Rate% [Within two hours after oocyte retrieval]

      Maturation Rate is calculated by dividing the number of mature (MII) oocytes by the number of retrieved oocytes

    4. Fertilization Rate% [16-18 hours after microinjection]

      Fertilization Rate is calculated by dividing the number of obtained zygote (2PN) by the number of injected oocytes

    5. Embryo Quality [Day of transfer (2 or 3 days after microinjection)]

      Embryos are assessed using Nikon SMZ1500 stereoscope

    6. Biochemical Pregnancy Rate% [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

    7. Clinical Pregnancy Rate% (Per Embryo Transfer) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Damascus University Damascus Syrian Arab Republic
    2 Orient Hospital Damascus Syrian Arab Republic

    Sponsors and Collaborators

    • Damascus University

    Investigators

    • Principal Investigator: Raghad MH Faisal, MD, Damascus University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Damascus University
    ClinicalTrials.gov Identifier:
    NCT05393011
    Other Study ID Numbers:
    • UDFP-Biochemistry-01-2022
    First Posted:
    May 26, 2022
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Keywords provided by Damascus University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 26, 2022