Clinical trial NCT05393011: Relationship Between Some Vitamins and Antioxidants With in Vitro Fertilization Outcomes
Official title: Vitamin D and Some Antioxidants and Trace Elements Levels in Women: Relationship With I.V.F Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: In Vitro Fertilization
Infertility
Keywords: Vitamin D
Vitamin E
Zinc
Glutathione peroxidase
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females attending Orient Fertility and Genetics Hospital for infertility treatment or pregnancy assistance

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood and follicular fluid vitamin D concentrations
timeFrame: Immediately after oocyte retrieval
measure: Blood and follicular fluid vitamin E concentrations
timeFrame: Immediately after oocyte retrieval
measure: Blood and follicular fluid zinc concentrations
timeFrame: Immediately after oocyte retrieval
measure: Blood and follicular fluid glutathione peroxidase concentrations
timeFrame: Immediately after oocyte retrieval
Secondary outcomes:
measure: Number of oocytes retrieved
timeFrame: Immediately after oocyte retrieval
measure: Number of Metaphase II Oocytes (MII)
timeFrame: Within two hours after oocyte retrieval
measure: Maturation Rate%
timeFrame: Within two hours after oocyte retrieval
measure: Fertilization Rate%
timeFrame: 16-18 hours after microinjection
measure: Embryo Quality
timeFrame: Day of transfer (2 or 3 days after microinjection)
measure: Biochemical Pregnancy Rate%
timeFrame: 2 weeks after embryo transfer
measure: Clinical Pregnancy Rate% (Per Embryo Transfer)
timeFrame: 4 weeks after embryo transfer
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
city: Damascus
country: Syrian Arab Republic
facility: Orient Hospital
Study officials:
affiliation: Damascus University
name: Raghad MH Faisal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.
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.