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Completed

NCT Number: NCT05393011

Relationship Between Some Vitamins and Antioxidants With in Vitro Fertilization 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.

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Key information

Conditions

In Vitro Fertilization Genital Diseases Infertility Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Damascus University, Damascus, Syria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Human Chorionic Gonadotropin

Drug

10000 IU when at least three follicles become more than 16 mm

Other names: Chorex

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Number of oocytes retrieved

    Time frame: 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)

    Time frame: Within two hours after oocyte retrieval

    The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope

  3. 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

  4. 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

  5. Embryo Quality

    Time frame: Day of transfer (2 or 3 days after microinjection)

    Embryos are assessed using Nikon SMZ1500 stereoscope

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
May 26, 2022
Registry last updated
May 26, 2022

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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