Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate

NCT05231980 | Completed Phase 2

• 1 other identifier: 86
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

This study evaluate the addition of PTX and ALA to clomiphene citrate in the treatment of polycystic ovary.

Conditions

Clomiphene Citrate; Resistant Ovary Syndrome; Polycystic Ovary Syndrome

Keywords

pentoxifylline; alpha lipoic acid; polycystic ovary; clomiphene

Outcome Measures

Primary Outcomes (1)

• ovulation rate measure the number of patients who ovulate per cycle

  Follicles measure more than 18 mm will be considered mature follicles.

  3 months

Study Arms (4)

Pentoxifylline (PTX) group

EXPERIMENTAL

30 patients

Drug: Pentoxifylline (PTX); Drug: Clomiphene Citrate

Alpha lipoic acid (ALA) group

EXPERIMENTAL

30 patients

Dietary Supplement: Alpha lipoic acid (ALA); Drug: Clomiphene Citrate

Combined PTX and ALA group

EXPERIMENTAL

30 patients

Dietary Supplement: Alpha lipoic acid (ALA); Drug: Pentoxifylline (PTX); Drug: Clomiphene Citrate

control group

ACTIVE COMPARATOR

clomiphene

Drug: Clomiphene Citrate

Interventions

Alpha lipoic acid (ALA) DIETARY_SUPPLEMENT

ALA is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect.

Also known as: thiotacid

Alpha lipoic acid (ALA) group; Combined PTX and ALA group

Pentoxifylline (PTX) DRUG

Pentoxifylline is a methylxanthine derivative which acts as a vasodilator by increasing blood flow to tissues, inhibits inflammatory responses, and reduces blood viscosity by impeding platelet aggregation

Also known as: trental

Combined PTX and ALA group; Pentoxifylline (PTX) group

Clomiphene Citrate DRUG

is a medication used to treat infertility in women who do not ovulate

Also known as: clomid

Alpha lipoic acid (ALA) group; Combined PTX and ALA group; Pentoxifylline (PTX) group; control group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS
• Age between 18 and 39 years.
• Period of infertility \>1 years.
• Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance
• Body mass index (18-30) kg/m2.

You may not qualify if:

• History of pelvic surgery or infertility factor other than anovulation
• Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations.
• Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency.
• Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date.
• Male factor infertility (sperm count \< 5 million per milliliter, normal morphology \<4%).
• Elevated serum prolactin, T.S.H and F.S.H.
• Patients diagnosed with diabetes mellitus
• Patients who are hypersensitive to pentoxifylline or other xanthines such as caffeine, theophylline and theobromine or to any ingredient in the formulation or component of the container.
• Patients with acute myocardial infraction, severe coronary artery disease.
• Patients with hemorrhage or at risk of increased bleeding and Patients with peptic ulcers.

Sponsors & Collaborators

• Ain Shams University: lead
• Misr University for Science and Technology: collaborator

Study Sites (3)

Medical Center of Infertility

Banī Suwayf, 62521, Egypt

Location

College of Pharmacy Teaching Hospital Ainshams University

Cairo, Egypt

Location

Misr University For Sciences and Technology Teaching Hospital

Giza, 12573, Egypt

Location

Related Publications (1)

• Morsy AA, Sabri NA, Mourad AM, Mojahed EM, Fahmy SF. New insights into pentoxifylline and alpha-lipoic acid: Co-administration with clomiphene citrate for ovulation induction in anovulatory women with polycystic ovary syndrome. Clin Exp Reprod Med. 2025 May 20. doi: 10.5653/cerm.2024.07346. Online ahead of print.

  PMID: 40393653 DERIVED

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Polycystic Ovary Syndrome

Interventions

Thioctic Acid; Pentoxifylline; Clomiphene

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Nagwa Al Sabri, Phd

  Ainshams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: prospective randomized controlled open label study

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 9, 2022
• Study Start: June 5, 2022
• Primary Completion: May 6, 2023
• Study Completion: June 7, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)