Relationship Between Some Vitamins and Antioxidants With in Vitro Fertilization Outcomes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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In Vitro Fertilization, Infertility

Intervention / Treatment
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* Drug: human chorionic gonadotropin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant group<br>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<br>* 10000 IU when at least three follicles become more than 16 mm<br>* Other names: Chorex;|
| Non-pregnant group<br>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<br>* 10000 IU when at least three follicles become more than 16 mm<br>* Other names: Chorex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood and follicular fluid vitamin D concentrations | 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 | 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 | 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 | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved | The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration after ovulation trigger | Immediately after oocyte retrieval | 
| Number of Metaphase II Oocytes (MII) | The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope | Within two hours after oocyte retrieval | 
| Maturation Rate% | 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% | 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 | Embryos are assessed using Nikon SMZ1500 stereoscope | Day of transfer (2 or 3 days after microinjection) | 
| Biochemical Pregnancy Rate% | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zinc, Vitamin D, Vitamin E, Glutathione peroxidase