Alpha-Lipoic Acid Supplementation and IVF Outcomes in Women of Advanced Maternal Age

NCT07685431 | Recruiting

• 1 other identifier: KSVGH26-CT3-49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Female fertility declines with advancing age, largely because of deteriorating oocyte quality driven by mitochondrial dysfunction and oxidative stress within the ovarian microenvironment. Alpha-lipoic acid (ALA) is a potent antioxidant that crosses cell and mitochondrial membranes, regenerates other antioxidants (vitamin C, vitamin E, glutathione, coenzyme Q10), and supports mitochondrial respiratory chain activity and ATP production. This prospective study will enroll 60 infertile women aged 35-45 years undergoing in vitro fertilization (IVF) treatment. Thirty participants will receive oral ALA 600 mg/day for two months before their IVF cycle, and thirty will proceed directly to IVF without supplementation. The study will compare oocyte and embryo quality, cumulus cell mitochondrial function and metabolic gene expression, and clinical pregnancy and live birth rates between the two groups.

Conditions

Female Infertility Due to Diminished Ovarian Reserve

Keywords

Alpha-lipoic acid; In vitro fertilization; Advanced maternal age; Oocyte quality; Mitochondrial function; Cumulus cells

Outcome Measures

Primary Outcomes (2)

• Embryo quality

  proportion of top-grade embryos (Day 3) or blastocysts (Day 5) per standard grading criteria

  through study completion, an average of 1 year

• Cumulus cell mitochondrial function

  ATP content, mitochondrial membrane potential, ROS level, and mitochondrial DNA copy number

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Clinical pregnancy rate

  through study completion, an average of 1 year

• Live birth rate

  through study completion, an average of 1 year

Study Arms (2)

Alpha-Lipoic Acid + IVF

EXPERIMENTAL

Participants receive oral alpha-lipoic acid 600 mg/day for 2 months, followed by a standard controlled ovarian stimulation IVF cycle

Dietary Supplement: Alpha-Lipoic Acid (ALA)

Standard IVF (Control)

NO INTERVENTION

Participants proceed directly to a standard controlled ovarian stimulation IVF cycle without alpha-lipoic acid or any other antioxidant supplementation.

Interventions

Alpha-Lipoic Acid (ALA) DIETARY_SUPPLEMENT

Oral Alpha-Lipoic Acid 600 mg/day for 2 months prior to IVF cycle initiation

Alpha-Lipoic Acid + IVF

Eligibility Criteria

• Age: 35 Years - 45 Years
• Gender Eligibility Details: Infertile women planning to undergo an IVF cycle using their own oocytes
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35-45 years
• BMI 18-35 kg/m²
• Planning to undergo IVF treatment using own oocytes

You may not qualify if:

• Primary ovarian insufficiency
• Azoospermia or severe male-factor infertility in the partner
• Congenital uterine anomaly
• Severe intrauterine adhesion
• Known chromosomal anomaly in either partner
• Malignancy
• Recipient of donor oocytes
• Known hypersensitivity/allergy to alpha-lipoic acid

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

RECRUITING

Related Publications (10)

• Erdem Guzel E, Kaya N, Tektemur A, Ulker N, Yardimci A, Akkoc RF, Canpolat S, Ozan IE. Chronic effects of maternal tobacco-smoke exposure and/or alpha-lipoic acid treatment on reproductive parameters in female rat offspring. Syst Biol Reprod Med. 2020 Dec;66(6):387-399. doi: 10.1080/19396368.2020.1815248. Epub 2020 Sep 20.

  PMID: 32951465 BACKGROUND

• Abu-Zaid A, Baradwan S, Bukhari IA, Alyousef A, Abuzaid M, Saleh SAK, Adly HM, Alomar O, Al-Badawi IA. The effect of alpha-lipoic acid supplementation on anthropometric, glycemic, lipid, oxidative stress, and hormonal parameters in individuals with polycystic ovary syndrome: a systematic review and meta-analysis of randomized clinical trials. Obstet Gynecol Sci. 2024 Jan;67(1):17-29. doi: 10.5468/ogs.23206. Epub 2023 Dec 4.

  PMID: 38044616 BACKGROUND

• Rago R, Marcucci I, Leto G, Caponecchia L, Salacone P, Bonanni P, Fiori C, Sorrenti G, Sebastianelli A. Effect of myo-inositol and alpha-lipoic acid on oocyte quality in polycystic ovary syndrome non-obese women undergoing in vitro fertilization: a pilot study. J Biol Regul Homeost Agents. 2015 Oct-Dec;29(4):913-23.

  PMID: 26753656 BACKGROUND

• Canosa S, Paschero C, Carosso A, Leoncini S, Mercaldo N, Gennarelli G, Benedetto C, Revelli A. Effect of a Combination of Myo-Inositol, Alpha-Lipoic Acid, and Folic Acid on Oocyte Morphology and Embryo Morphokinetics in non-PCOS Overweight/Obese Patients Undergoing IVF: A Pilot, Prospective, Randomized Study. J Clin Med. 2020 Sep 12;9(9):2949. doi: 10.3390/jcm9092949.

  PMID: 32932604 BACKGROUND

• Di Nicuolo F, D'Ippolito S, Castellani R, Rossi ED, Masciullo V, Specchia M, Mariani M, Pontecorvi A, Scambia G, Di Simone N. Effect of alpha-lipoic acid and myoinositol on endometrial inflammasome from recurrent pregnancy loss women. Am J Reprod Immunol. 2019 Sep;82(3):e13153. doi: 10.1111/aji.13153. Epub 2019 Jun 19.

  PMID: 31148259 BACKGROUND

• Di Tucci C, Galati G, Mattei G, Bonanni V, Capri O, D'Amelio R, Muzii L, Benedetti Panici P. The role of alpha lipoic acid in female and male infertility: a systematic review. Gynecol Endocrinol. 2021 Jun;37(6):497-505. doi: 10.1080/09513590.2020.1843619. Epub 2020 Dec 21.

  PMID: 33345661 BACKGROUND

• Guarano A, Capozzi A, Cristodoro M, Di Simone N, Lello S. Alpha Lipoic Acid Efficacy in PCOS Treatment: What Is the Truth? Nutrients. 2023 Jul 19;15(14):3209. doi: 10.3390/nu15143209.

  PMID: 37513627 BACKGROUND

• Shanaida M, Lysiuk R, Mykhailenko O, Hudz N, Abdulsalam A, Gontova T, Oleshchuk O, Ivankiv Y, Shanaida V, Lytkin D, Bjorklund G. Alpha-lipoic Acid: An Antioxidant with Anti-aging Properties for Disease Therapy. Curr Med Chem. 2025;32(1):23-54. doi: 10.2174/0109298673300496240416114827.

  PMID: 38644711 BACKGROUND

• Zhang M, Sun L, Zhang Z, Shentu L, Zhang Y, Li Z, Zhang Y, Zhang Y. Alpha-lipoic acid supplementation restores the meiotic competency and fertilization capacity of porcine oocytes induced by arsenite. Front Cell Dev Biol. 2022 Oct 3;10:943757. doi: 10.3389/fcell.2022.943757. eCollection 2022.

  PMID: 36263016 BACKGROUND

• Di Nicuolo F, Castellani R, Ticconi C, Scambia G, Pontecorvi A, Di Simone N. alpha-Lipoic Acid and its Role on Female Reproduction. Curr Protein Pept Sci. 2021 Dec 29;22(11):767-774. doi: 10.2174/1389203722666211029102417.

  PMID: 34719371 BACKGROUND

MeSH Terms

Interventions

Thioctic Acid

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Kuan-Hao Tsui

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

Central Study Contacts

Li-Te Lin

CONTACT

+886-7-3464027; litelin1982@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)