Infertility (IVF Patients)
Conditions
Keywords
supplementation, IVF, carnitine
Brief summary
The goal of this clinical trial is to learn whether supplementation with L-carnitine improves outcomes in women undergoing in vitro fertilization (IVF). It will also evaluate the effect of supplementation on oocyte quality, embryo quality, and pregnancy rates. The main questions it aims to answer are: * Does supplementation improve the number and quality of oocytes retrieved during IVF treatment? * Does supplementation improve the number and quality of embryos obtained after fertilization? * Does supplementation increase the rates of biochemical and clinical pregnancy? Researchers will compare women receiving supplementation with women not receiving supplementation to determine whether the supplements improve IVF outcomes.
Detailed description
Participants will: * Be women undergoing IVF treatment at the Narodni Front Clinic of Gynecology and Obstetrics who meet the study eligibility criteria and agree to participate. * Be randomly assigned, using the sealed-envelope method, to one of two groups: * A supplementation group receiving L-arginine (500 mg), L-carnitine (500 mg), N-acetyl-L-carnitine (250 mg), and myo-inositol (1000 mg) daily. * A control group receiving no supplementation. * Take the assigned supplementation for 12 weeks before oocyte retrieval. * Undergo assessment of the number and quality of retrieved oocytes after oocyte aspiration as part of the standard IVF procedure. * If fertilization occurs and embryos are obtained, have the number and quality of embryos evaluated as part of the standard IVF procedure. * Have serum beta-human chorionic gonadotropin (β-hCG) measured 13 days after embryo transfer to assess biochemical pregnancy as part of the standard IVF procedure. * If biochemical pregnancy is achieved (β-hCG \> 50 IU/L), undergo an ultrasound examination 35 days after embryo transfer to confirm clinical pregnancy as part of the standard IVF procedure.
Interventions
DIETARY_SUPPLEMENTL-Carnitine Group
A supplementation group will receive L-carnitine (500 mg) daily for 12 weeks before oocyte retrieval.
Sponsors
The Obstetrics and Gynaecology Clinic Narodni Front
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* women undergoing IVF process * women aged 18-45 years
Exclusion criteria
* obesity * severe kidney disease * liver insufficiency * endocrine disorders * the use of immunosuppressive medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The impact of carnitine supplementation on the number of oocytes retrieved during in vitro fertilization and on IVF outcomes. | 3 months | Assessment of the total count of oocytes retrieved per patient during transvaginal ultrasound-guided oocyte retrieval following controlled ovarian stimulation. Unit of measure: number of oocytes /count/ Measurement tool: inverted light microscope |
| The impact of carnitine supplementation on the number of good quality oocytes (metaphase II (MII) oocytes) retrieved during oocyte pick-up | 3 months | Good quality oocytes (metaphase II oocytes) will be identified according to standard ESHRE consensus morphological criteria (evaluating polar body presence, cytoplasm texture, and zona pellucida integrity) using inverted light microscope as measurement tool, following denudation in cases of intracytoplasmatic sperm injection (ICSI) or Metaphase II (MII) oocytes will be identified based on successful fertilization (presence of two pronuclei, 2PN) using inverted light microscope following insemination as part of the IVF procedure. Unit of measure: number of metaphase II (MII) oocytes /count/ Measurement tool: inverted light microscope |
Countries
Serbia
Contacts
CONTACTMilan D PEROVIC, Ass. Prof., PhD
Outcome results
None listed