NCT07783399

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
May 2026Sep 2026

Study Start

First participant enrolled

May 15, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2026

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

July 20, 2026

Last Update Submit

August 20, 2026

Conditions

Keywords

supplementationIVFcarnitine

Outcome Measures

Primary Outcomes (2)

  • The impact of carnitine supplementation on the number of oocytes retrieved during in vitro fertilization and on IVF outcomes.

    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

    3 months

  • The impact of carnitine supplementation on the number of good quality oocytes (metaphase II (MII) oocytes) retrieved during oocyte pick-up

    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

    3 months

Study Arms (2)

L-Carnitine Group

EXPERIMENTAL

Participants in this arm will receive oral L-carnitine supplementation at a dose of 500 mg daily (once daily, powder dissolved in water, orally) starting 12 weeks before the day of oocyte retrieval.

Dietary Supplement: L-Carnitine Group

No supplementation

NO INTERVENTION

Participants who have not used carnitin supplementation.

Interventions

L-Carnitine GroupDIETARY_SUPPLEMENT

A supplementation group will receive L-carnitine (500 mg) daily for 12 weeks before oocyte retrieval.

L-Carnitine Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women undergoing IVF process
  • women aged 18-45 years

You may not qualify if:

  • obesity
  • severe kidney disease
  • liver insufficiency
  • endocrine disorders
  • the use of immunosuppressive medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Gynecology and Obstetrics Narodni Front

Belgrade, Savski Venac, 11000, Serbia

RECRUITING

Related Publications (7)

  • Placidi M, Di Emidio G, Virmani A, D'Alfonso A, Artini PG, D'Alessandro AM, Tatone C. Carnitines as Mitochondrial Modulators of Oocyte and Embryo Bioenergetics. Antioxidants (Basel). 2022 Apr 8;11(4):745. doi: 10.3390/antiox11040745.

    PMID: 35453430BACKGROUND
  • Kalehoei E, Moradi M, Azadbakht M, Zhaleh H, Abadi SAL, Mahdiuni H, Gharzi A. Therapeutic effects of L-arginine, L-carnitine, and mesenchymal stem cell-conditioned medium on endometriosis-induced oocyte poor quality in an experimental mouse model. J Obstet Gynaecol Res. 2023 Apr;49(4):1180-1188. doi: 10.1111/jog.15569. Epub 2023 Feb 3.

    PMID: 36738084BACKGROUND
  • Perovic MD, Sudar-Milovanovic EM, Simonovic ED, Resanovic IM, Draganic VD, Radakovic JD, Soldatovic IA, Isenovic ER. Hypothesis regarding the effects of gonadotropins on the level of free fatty acids and phospholipids in serum and follicular fluid during controlled ovarian stimulation. Med Hypotheses. 2019 Feb;123:30-34. doi: 10.1016/j.mehy.2018.11.021. Epub 2018 Dec 18.

    PMID: 30696588BACKGROUND
  • Kitano Y, Hashimoto S, Matsumoto H, Yamochi T, Yamanaka M, Nakaoka Y, Fukuda A, Inoue M, Ikeda T, Morimoto Y. Oral administration of l-carnitine improves the clinical outcome of fertility in patients with IVF treatment. Gynecol Endocrinol. 2018 Aug;34(8):684-688. doi: 10.1080/09513590.2018.1431769. Epub 2018 Jan 29.

    PMID: 29378447BACKGROUND
  • Hafezi M, Arabipoor A, Ghaffari F, Vesali S, Zareei M, Hessari ZH. Adding L-carnitine to antagonist ovarian stimulation doesn't improve the outcomes of IVF/ ICSI cycle in patients with polycystic ovarian syndrome: a double-blind randomized clinical trial. J Ovarian Res. 2024 Jan 9;17(1):9. doi: 10.1186/s13048-023-01319-7.

    PMID: 38191449BACKGROUND
  • Dunning KR, Robker RL. Promoting lipid utilization with l-carnitine to improve oocyte quality. Anim Reprod Sci. 2012 Sep;134(1-2):69-75. doi: 10.1016/j.anireprosci.2012.08.013. Epub 2012 Aug 11.

    PMID: 22917873BACKGROUND
  • Zhao W, Liu K, Zhang Y, Sun P, Zeringue E, Meng L, Ma H. The efficacy of orally administered L-carnitine in alleviating ovarian dysfunctions has laid the foundation for targeted in vivo use: a study employing self-control and propensity score matching. Front Endocrinol (Lausanne). 2024 Sep 18;15:1440182. doi: 10.3389/fendo.2024.1440182. eCollection 2024.

    PMID: 39359417BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Milan D PEROVIC, Ass. Prof., PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of IVF Department

Study Record Dates

First Submitted

July 20, 2026

First Posted

August 24, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 20, 2026

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations