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Relationship Between Some Vitamins and Antioxidants With in Vitro Fertilization Outcomes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05393011
Enrollment
60
Registered
2022-05-26
Start date
2017-08-20
Completion date
2021-08-15
Last updated
2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, In Vitro Fertilization

Keywords

Vitamin D, Vitamin E, Zinc, Glutathione peroxidase

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.

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.

Interventions

DRUGhuman chorionic gonadotropin

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

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Blood and follicular fluid vitamin D concentrationsImmediately after oocyte retrievalBlood 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
Blood and follicular fluid vitamin E concentrationsImmediately after oocyte retrievalBlood 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
Blood and follicular fluid zinc concentrationsImmediately after oocyte retrievalBlood 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
Blood and follicular fluid glutathione peroxidase concentrationsImmediately after oocyte retrievalBlood 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

MeasureTime frameDescription
Embryo QualityDay of transfer (2 or 3 days after microinjection)Embryos are assessed using Nikon SMZ1500 stereoscope
Number of oocytes retrievedImmediately after oocyte retrievalThe oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration after ovulation trigger
Clinical Pregnancy Rate% (Per Embryo Transfer)4 weeks after embryo transferweeks 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
Biochemical Pregnancy Rate%2 weeks after embryo transferBiochemical 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
Number of Metaphase II Oocytes (MII)Within two hours after oocyte retrievalThe oocyte maturity will be assessed using Nikon SMZ1500 stereoscope
Maturation Rate%Within two hours after oocyte retrievalMaturation Rate is calculated by dividing the number of mature (MII) oocytes by the number of retrieved oocytes
Fertilization Rate%16-18 hours after microinjectionFertilization Rate is calculated by dividing the number of obtained zygote (2PN) by the number of injected oocytes

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026