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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant group | A female is considered pregnant when an explicit gestational sac inside the uterus is seen by ultrasound 4 weeks after embryo transfer. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human chorionic gonadotropin | Drug | 10000 IU when at least three follicles become more than 16 mm |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Females attending Orient Fertility and Genetics Hospital for infertility treatment or pregnancy assistance
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| Name | Affiliation | Role |
|---|---|---|
| Raghad MH Faisal, MD | Damascus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damascus University | Damascus | Syria | ||||
| Orient Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19413899 | Background | Revelli A, Delle Piane L, Casano S, Molinari E, Massobrio M, Rinaudo P. Follicular fluid content and oocyte quality: from single biochemical markers to metabolomics. Reprod Biol Endocrinol. 2009 May 4;7:40. doi: 10.1186/1477-7827-7-40. | |
| 28903472 | Background | Lambalk CB, Banga FR, Huirne JA, Toftager M, Pinborg A, Homburg R, van der Veen F, van Wely M. GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta-analysis accounting for patient type. Hum Reprod Update. 2017 Sep 1;23(5):560-579. doi: 10.1093/humupd/dmx017. |
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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
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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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 |
| Damascus |
| Syria |
| 34154571 | Background | Aramesh S, Alifarja T, Jannesar R, Ghaffari P, Vanda R, Bazarganipour F. Does vitamin D supplementation improve ovarian reserve in women with diminished ovarian reserve and vitamin D deficiency: a before-and-after intervention study. BMC Endocr Disord. 2021 Jun 21;21(1):126. doi: 10.1186/s12902-021-00786-7. |
| 31319865 | Background | Liu X, Zhang W, Xu Y, Chu Y, Wang X, Li Q, Ma Z, Liu Z, Wan Y. Effect of vitamin D status on normal fertilization rate following in vitro fertilization. Reprod Biol Endocrinol. 2019 Jul 18;17(1):59. doi: 10.1186/s12958-019-0500-0. |
| 29282414 | Background | Bahadori MH, Sharami SH, Fakor F, Milani F, Pourmarzi D, Dalil-Heirati SF. Level of Vitamin E in Follicular Fluid and Serum and Oocyte Morphology and Embryo Quality in Patients Undergoing IVF Treatment. J Family Reprod Health. 2017 Jun;11(2):74-81. |
| 34155866 | Background | Janati S, Behmanesh MA, Najafzadehvarzi H, Akhundzade Z, Poormoosavi SM. Follicular Fluid Zinc Level and Oocyte Maturity and Embryo Quality in Women with Polycystic Ovary Syndrome. Int J Fertil Steril. 2021 Jul;15(3):197-201. doi: 10.22074/IJFS.2021.135426.1006. Epub 2021 Jun 22. |
| 32754677 | Background | Zal F, Ahmadi P, Davari M, Khademi F, Jahromi MA, Anvar Z, Jahromi BN. Glutathione-dependent enzymes in the follicular fluid of the first-retrieved oocyte and their impact on oocyte and embryos in polycystic ovary syndrome: A cross-sectional study. Int J Reprod Biomed. 2020 Jun 30;18(6):415-424. doi: 10.18502/ijrm.v13i6.7283. eCollection 2020 Jun. |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |