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

Phase 2CompletedNCT05231980

Ain Shams University120 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Clomiphene Citrate Resistant Ovary Syndrome Polycystic Ovary Syndrome

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.

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

Clomiphene CitrateDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

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.

Locations (3)

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

Outcomes

Primary Outcomes

ovulation rate measure the number of patients who ovulate per cycle

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

Time frame: 3 months

Data from ClinicalTrials.gov

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