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

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Collaborator: Misr University for Science and Technology
• Treatments: Clomiphene; Enclomiphene; Pentoxifylline; Thioctic Acid; Zuclomiphene

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.