Relationship Between Some Vitamins and Antioxidants With in Vitro Fertilization Outcomes

NCT05393011 | Completed DMC FDA Drug

• 1 other identifier: UDFP-Biochemistry-01-2022
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

In Vitro Fertilization; Infertility

Keywords

Vitamin D; Vitamin E; Zinc; Glutathione peroxidase

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Number of oocytes retrieved

  Immediately after oocyte retrieval

• Number of Metaphase II Oocytes (MII)

  Within two hours after oocyte retrieval

• Maturation Rate%

  Within two hours after oocyte retrieval

• Fertilization Rate%

  16-18 hours after microinjection

• Embryo Quality

  Day of transfer (2 or 3 days after microinjection)

Study Arms (2)

Pregnant group

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

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.

Drug: human chorionic gonadotropin

Interventions

human chorionic gonadotropin DRUG

10000 IU when at least three follicles become more than 16 mm

Also known as: Chorex

Non-pregnant group; Pregnant group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Females attending Orient Fertility and Genetics Hospital for infertility treatment or pregnancy assistance

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (2)

Damascus University

Damascus, Syria

Location

Orient Hospital

Damascus, Syria

Location

Related Publications (7)

• 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.

  PMID: 19413899 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.

  PMID: 28903472 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.

  PMID: 34154571 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.

  PMID: 31319865 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.

  PMID: 29282414 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.

  PMID: 34155866 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.

  PMID: 32754677 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Raghad MH Faisal, MD

  Damascus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: August 20, 2017
• Primary Completion: August 2, 2020
• Study Completion: August 15, 2021
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

SY (2)