Relationship Between Some Vitamins and Antioxidants With in Vitro Fertilization Outcomes

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05393011
• Other study ID #: UDFP-Biochemistry-01-2022
• Status: Completed
• Start date: August 20, 2017
• Est. completion date: August 15, 2021

Study information

• Verified date: May 2022
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 15, 2021
• Est. primary completion date: August 2, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• In Vitro Fertilization
• Infertility

Intervention

Drug:
• human chorionic gonadotropin
10000 IU when at least three follicles become more than 16 mm

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus
Syrian Arab Republic	Orient Hospital	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Number of oocytes retrieved	The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration after ovulation trigger	Immediately after oocyte retrieval
Secondary	Number of Metaphase II Oocytes (MII)	The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope	Within two hours after oocyte retrieval
Secondary	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
Secondary	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
Secondary	Embryo Quality	Embryos are assessed using Nikon SMZ1500 stereoscope	Day of transfer (2 or 3 days after microinjection)
Secondary	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
Secondary	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