Nutritional Status of Women Undergoing in Vitro Fertilization

NCT05865015 | Completed

• 1 other identifier: TP20210218
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

Infertility affects around 15 % of couples in their reproductive years. Even though the use of assisted reproductive technologies (ART) in aforementioned couples is increasing, their success rate is still relatively low. Hence it is important to identify and better understand potential modifiable dietary and lifestyle risk factors that may influence the success of ART. This study will include women undergoing IVF with a view to investigating the relationship between preconception dietary patterns, body composition, physical activity level, serum values of vitamin B9, vitamin B12 and vitamin D and the outcomes of IVF, such as the number of obtained oocytes, fertilization rate and clinical pregnancy. Main hypothesis is that women undergoing IVF, who eat a balanced diet, maintain healthy body weight and have adequate serum levels of vitamin B9, vitamin B12 and vitamin D, have a higher chance of achieving better IVF outcomes.

Conditions

IVF; Body Weight; Nutrient Deficiency; Dietary Vitamin B12 Deficiency Anemia; Dietary Folate Deficiency Anemia

Keywords

Dietary Patterns; Mediterranean diet; In Vitro Fertilization; Diet; Fertility; Infertility; Assisted Reproduction

Outcome Measures

Primary Outcomes (1)

• Oocyte number

  Total Number of oocytes produced.

  3 months

Secondary Outcomes (1)

• Fertilization rate

  3 months

Other Outcomes (1)

• Clinical pregnancy rate

  6 months

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing IVF treatment at the University Medical Centre Ljubljana.

You may qualify if:

• Undergoing IVF/ICSI treatment

You may not qualify if:

• Women's age \> 39
• Endometriosis

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (2)

Division of Ob/Gyn, University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Division of Peadiatrics, University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The patient will have blood drawn for biochemical laboratory tests at the Clinical Institute of Clinical Chemistry and Biochemistry, University Clinical Centre Ljubljana (in addition to the standard tests, the investigators will also determine vitamin B9 or folate and folic acid, vitamin B12, vitamin D, oligoelements, heavy metals, hormone disruptors, etc.) The protection of personal data will be guaranteed, as each blood sample will be labelled or recorded during the study under a code identical to the code of the questionnaire completed by the patient. Information on the results of the IVF/ICSI procedure will be obtained from the patients' medical records with their consent.

MeSH Terms

Conditions

Body Weight; Infertility

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: January 5, 2023
• Primary Completion: March 2, 2023
• Study Completion: September 10, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-02

Locations

SL (2)