The Effects of Acetyl-L-Carnitine and Myo/Chiro-Inositol in Patients With PCOS

NCT05767515 | Completed DMC

• 2 other identifiers: NO:KMU/IBMS/2020/45F.No.SG-21-153/RDC/691
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The large number of women in their child bearing age is affected by Polycystic ovarian syndrome (PCOS) leading to infertility. However it is considered as a multisystem disorder with comorbidities rather than a gynecological and a dermatological problem. Patient mostly have anovulation presented as oligomennorhea or amenorrhea and hyperandrogenism presented as hirsutism along with hyperinsulinemia and insulin resistance. Many etiological factors are reported but those actually responsible for PCOS in females still need to be explored. However hyperandrogenism and insulin resistance being the key triggering condition apart from cardiovascular disease, type 2 diabetes, hypertension and obesity. World Health Organization (WHO) has considered Infertility's as public health problem. Researchers reported the obesity role in occurrence of PCOS and its Infertility's relation . PCOS is not a simple pathophysiologic process for which one treatment address all manifestation. Treatment should target specific manifestations and individualized patient goals. First-line agents for ovulation induction and treatment of infertility in patients with PCOS include metformin and clomiphene alone or in combination. It has been approved as category "A "to regulate ovulation and improves pregnancy rates in women with PCOS . Mostly it result in complication like multiple follicle recruitment rate, multiple pregnancy and thinning of endometrial wall leading to early abortion and endometrial cancers. The use of naturally occurring compounds like myoinositol, D-chiro- inositol and L- carnitine which are already part of human body are expected to produce significant results without any side effects . The proposed study will provide an alternative to current treatments available for infertility due to PCOS. The expected project execution time is 2 years. Thus, the present project will discover new insights about treatment of infertility and thus generate new knowledge which will help Academia, scientists and health care professionals. Results of the study will be disseminated on different forums including to policy makers , Pharmaceutical, national and international agencies. The result will be published in journal both national and international with good impact factors. The outcome of the project will be used as publication in high impact international journals, filling of patents and will also be presented in national and international forums.

Conditions

Infertility, Female; PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Keywords

PCOS, INFERTILTY

Outcome Measures

Primary Outcomes (1)

• CLINICAL PREGNANCY

  intrauterine pregnancy with positive fetal heart motion as determined on transvaginal ultrasound or HCG level is more than 1500IU/L

  6 MONTHS

Secondary Outcomes (4)

• OVULATION

  6 MONTHS

• Conception

  6 Months

• Biochemical Pregnancy

  6 months

• tetosterone levels

  6 MONTHS

Study Arms (4)

Metformin Group

ACTIVE COMPARATOR

Metformin will be used in dose of 1000 mg BD daily for 30 infertile female PCOS patients

Drug: metformin

Inositol isomers Group

EXPERIMENTAL

Inositols isomers (Myo inositol and D- Chiro Inositol in its physiological ratio) will be used 2000mg BD Daily for 30 infertile female PCOS patients

Drug: metformin

Acetyl-L- Carnitine Group

EXPERIMENTAL

Acetyl-L-Carnitine will be given in dose of 1000mgBD Daily for 30 infertile female PCOS patients

Drug: metformin

Combine Group

EXPERIMENTAL

Inositol isomers and Acetyl-L-Carnitine will be given in dose of 2000mg and 1000mg respectively BD daily for 30 infertile female PCOS patients

Drug: metformin

Interventions

metformin DRUG

Treatment of infertile female with PCOS with inositol isomers and Acetyl-L-Carnitine

Also known as: myo inositol, D- chiro Inositol, Acetyl-L-Carnitine

Acetyl-L- Carnitine Group; Combine Group; Inositol isomers Group; Metformin Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Infertilty
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A. Hyperandrogenism plus Ovulatory dysfunction plus Polycystic Ovarian Morphology (HA +OD+PCOM) B. Hyperandrogenism plus Ovulatory dysfunction (HA+OD) C. Hyperandrogenism plus Poly Cystic Ovarian Morphology (HA+PCOM). D. Ovulatory dysfunction plus Polycystic Ovarian Morphology (OD+PCO)

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead
• University of Cagliari: collaborator

Study Sites (1)

Khyber Medical University

Peshawar, Pakistan

Location

Related Publications (14)

• Rubin KH, Glintborg D, Nybo M, Abrahamsen B, Andersen M. Development and Risk Factors of Type 2 Diabetes in a Nationwide Population of Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3848-3857. doi: 10.1210/jc.2017-01354.

  PMID: 28938447 BACKGROUND

• Orio F, Palomba S. Reproductive endocrinology: New guidelines for the diagnosis and treatment of PCOS. Nat Rev Endocrinol. 2014 Mar;10(3):130-2. doi: 10.1038/nrendo.2013.248. Epub 2013 Dec 10.

  PMID: 24322653 BACKGROUND

• Akram M, Roohi N. Endocrine correlates of polycystic ovary syndrome in Pakistani women. J Coll Physicians Surg Pak. 2015 Jan;25(1):22-6.

  PMID: 25604364 BACKGROUND

• Chauhan B, Kumar G, Kalam N, Ansari SH. Current concepts and prospects of herbal nutraceutical: A review. J Adv Pharm Technol Res. 2013 Jan;4(1):4-8. doi: 10.4103/2231-4040.107494.

  PMID: 23662276 BACKGROUND

• An H, He L. Current understanding of metformin effect on the control of hyperglycemia in diabetes. J Endocrinol. 2016 Mar;228(3):R97-106. doi: 10.1530/JOE-15-0447. Epub 2016 Jan 7.

  PMID: 26743209 BACKGROUND

• Mansfield R, Galea R, Brincat M, Hole D, Mason H. Metformin has direct effects on human ovarian steroidogenesis. Fertil Steril. 2003 Apr;79(4):956-62. doi: 10.1016/s0015-0282(02)04925-7.

  PMID: 12749437 BACKGROUND

• Morley LC, Tang T, Yasmin E, Norman RJ, Balen AH. Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility. Cochrane Database Syst Rev. 2017 Nov 29;11(11):CD003053. doi: 10.1002/14651858.CD003053.pub6.

  PMID: 29183107 BACKGROUND

• Tauqir S, Israr M, Rauf B, Malik MO, Habib SH, Shah FA, Usman M, Raza MA, Shah I, Badshah H, Ehtesham E, Shah M. Acetyl-L-Carnitine Ameliorates Metabolic and Endocrine Alterations in Women with PCOS: A Double-Blind Randomized Clinical Trial. Adv Ther. 2021 Jul;38(7):3842-3856. doi: 10.1007/s12325-021-01789-5. Epub 2021 May 28.

  PMID: 34047916 BACKGROUND

• Salehpour S, Nazari L, Hoseini S, Moghaddam PB, Gachkar L. Effects of L-carnitine on Polycystic Ovary Syndrome. JBRA Assist Reprod. 2019 Oct 14;23(4):392-395. doi: 10.5935/1518-0557.20190033.

  PMID: 31294953 BACKGROUND

• 10. Porcaro G, Bizzarri M, Monastra G, et al Strategies for the treatment of polycystic ovary syndrome (PCOS) women: the role of myoinositol (MI) and d-chiro-inositol (DCI) between diet and therapy. Nova science publishers. 2016 1-18

  BACKGROUND

• 11. Facchinetti F, Dante G, Neri I. The ratio of MI to DCI and its impact in the treatment of polycystic ovary syndrome: experimental and literature evidences. Front Gynecol Endocrinol 2015;3:103-9.

  BACKGROUND

• Heimark D, McAllister J, Larner J. Decreased myo-inositol to chiro-inositol (M/C) ratios and increased M/C epimerase activity in PCOS theca cells demonstrate increased insulin sensitivity compared to controls. Endocr J. 2014;61(2):111-7. doi: 10.1507/endocrj.ej13-0423. Epub 2013 Nov 2.

  PMID: 24189751 BACKGROUND

• Bevilacqua A, Bizzarri M. Inositols in Insulin Signaling and Glucose Metabolism. Int J Endocrinol. 2018 Nov 25;2018:1968450. doi: 10.1155/2018/1968450. eCollection 2018.

  PMID: 30595691 BACKGROUND

• Gul M, Khan H, Rauf B, Bukhari SMS, Ehtesham E, Malik MO, Shah FA, Alanazi FE, Shah M. Comparative efficacy of combined myo-inositol and D-chiro inositol versus metformin across PCOS Phenotypes: enhancing ovarian function, ovulation, and stress response in a prospective clinical trial. Naunyn Schmiedebergs Arch Pharmacol. 2025 Jul;398(7):8761-8772. doi: 10.1007/s00210-025-03813-9. Epub 2025 Jan 23.

  PMID: 39847053 DERIVED

MeSH Terms

Conditions

Infertility, Female; Polycystic Ovary Syndrome

Interventions

Metformin; Inositol; Acetylcarnitine

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sugar Alcohols; Alcohols; Carbohydrates; Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment of PCOS with Myo/D-chiro Inositol and comparison with metformin

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: July 15, 2023
• Primary Completion: February 25, 2024
• Study Completion: March 10, 2024
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)