An observational study in In Vitro Fertilization and Infertility, sponsored by Damascus University. Completed at 2 sites in Syrian Arab Republic. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by Damascus University · Observational
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.
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 60 is below the median of 200 across 714 observational studies indexed under Infertility.
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Females attending Orient Fertility and Genetics Hospital for infertility treatment or pregnancy assistance
Exclusion Criteria:
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
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
Also known as: Chorex
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Immediately after oocyte retrieval
Number of oocytes retrieved
The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration after ovulation trigger
Time frame: Immediately after oocyte retrieval
Number of Metaphase II Oocytes (MII)
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope
Time frame: 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
Time frame: 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
Time frame: 16-18 hours after microinjection
Embryo Quality
Embryos are assessed using Nikon SMZ1500 stereoscope
Time frame: 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
Time frame: 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
Time frame: 4 weeks after embryo transfer
Plan to share: Undecided — 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
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Damascus University