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

Phase 2

Completed

• Conditions: Clomiphene Citrate; Resistant Ovary Syndrome; Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: Alpha lipoic acid (ALA); Drug: Pentoxifylline (PTX); Drug: Clomiphene Citrate

• Registration Number: NCT05231980
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-09
• Study Start: 2022-06-05
• Primary Completion: 2023-05-06
• Study Completion: 2023-06-07
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined PTX and ALA group	Pentoxifylline (PTX)	30 patients
Combined PTX and ALA group	Clomiphene Citrate	30 patients
Combined PTX and ALA group	Alpha lipoic acid (ALA)	30 patients
Pentoxifylline (PTX) group	Pentoxifylline (PTX)	30 patients
Alpha lipoic acid (ALA) group	Alpha lipoic acid (ALA)	30 patients
Pentoxifylline (PTX) group	Clomiphene Citrate	30 patients
Alpha lipoic acid (ALA) group	Clomiphene Citrate	30 patients
control group	Clomiphene Citrate	clomiphene

Primary Outcome Measures

Name	Time	Method
ovulation rate measure the number of patients who ovulate per cycle	3 months	Follicles measure more than 18 mm will be considered mature follicles.

Trial Locations

Locations (3)

College of Pharmacy Teaching Hospital Ainshams University; 🇪🇬 Cairo, Egypt

Medical Center of Infertility; 🇪🇬 Banī Suwayf, Egypt

Misr University For Sciences and Technology Teaching Hospital; 🇪🇬 Giza, Egypt