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

NCT ID: NCT05231980

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-05
• Study Completion Date: 2023-06-07

Brief Summary

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

Detailed Description

Clomiphene, PTX and ALA each used in treatment of pco but they do so by different mechanisms.

Clomifene is in the selective estrogen receptor modulator (SERM) family of medication. It works by causing the release of gonadotropin-releasing hormone by the hypothalamus, and subsequently gonadotropin from the anterior pituitary.

PTX and ALA are used in treatment of pco due its anti-oxidant effect.

Conditions

Clomiphene Citrate; Resistant Ovary Syndrome; Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pentoxifylline (PTX) group

30 patients

Group Type: EXPERIMENTAL

Pentoxifylline (PTX)

Intervention Type: 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

Clomiphene Citrate

Intervention Type: DRUG

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

Alpha lipoic acid (ALA) group

30 patients

Group Type: EXPERIMENTAL

Alpha lipoic acid (ALA)

Intervention Type: DIETARY_SUPPLEMENT

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

Clomiphene Citrate

Intervention Type: DRUG

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

Combined PTX and ALA group

30 patients

Group Type: EXPERIMENTAL

Alpha lipoic acid (ALA)

Intervention Type: DIETARY_SUPPLEMENT

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

Pentoxifylline (PTX)

Intervention Type: 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

Clomiphene Citrate

Intervention Type: DRUG

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

control group

clomiphene

Group Type: ACTIVE_COMPARATOR

Clomiphene Citrate

Intervention Type: DRUG

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

Interventions

Alpha lipoic acid (ALA)

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

Intervention Type: DIETARY_SUPPLEMENT

Pentoxifylline (PTX)

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

Intervention Type: DRUG

Clomiphene Citrate

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

Intervention Type: DRUG

Other Intervention Names

thiotacid; trental; clomid

Eligibility Criteria

Inclusion Criteria

1. Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS

2. Age between 18 and 39 years.

3. Period of infertility >1 years.

4. Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance

5. Body mass index (18-30) kg/m2.

Exclusion Criteria

1. History of pelvic surgery or infertility factor other than anovulation

2. Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations.

3. Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency.

4. Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date.

5. Male factor infertility (sperm count < 5 million per milliliter, normal morphology <4%).

6. Elevated serum prolactin, T.S.H and F.S.H.

7. Patients diagnosed with diabetes mellitus

8. 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.

9. Patients with acute myocardial infraction, severe coronary artery disease.

10. Patients with hemorrhage or at risk of increased bleeding and Patients with peptic ulcers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Misr University for Science and Technology

OTHER

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abbas Morsy Morsy

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nagwa Al Sabri, Phd

Role: STUDY_DIRECTOR

Ainshams university

Locations

Medical Center of Infertility

Banī Suwayf, , Egypt

College of Pharmacy Teaching Hospital Ainshams University

Cairo, , Egypt

Misr University For Sciences and Technology Teaching Hospital

Giza, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 40393653 (View on PubMed)

Other Identifiers

86

Identifier Type: -

Identifier Source: org_study_id