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

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

Detailed Description
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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.

Official Title
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Evaluation of the Effect of Pentoxifylline and α-Lipoic Acid as Adjunctive Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Conditions
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Clomiphene Citrate, Resistant Ovary Syndrome, Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: Alpha lipoic acid (ALA)
* Drug: Pentoxifylline (PTX)
* Drug: Clomiphene Citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized controlled open label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pentoxifylline (PTX) group<br>30 patients | Drug: Pentoxifylline (PTX)<br>* 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<br>* Other names: trental;Drug: Clomiphene Citrate<br>* is a medication used to treat infertility in women who do not ovulate<br>* Other names: clomid;|
| Experimental: Alpha lipoic acid (ALA) group<br>30 patients | Dietary Supplement: Alpha lipoic acid (ALA)<br>* ALA is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect.<br>* Other names: thiotacid;Drug: Clomiphene Citrate<br>* is a medication used to treat infertility in women who do not ovulate<br>* Other names: clomid;|
| Experimental: Combined PTX and ALA group<br>30 patients | Dietary Supplement: Alpha lipoic acid (ALA)<br>* ALA is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect.<br>* Other names: thiotacid;Drug: Pentoxifylline (PTX)<br>* 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<br>* Other names: trental;Drug: Clomiphene Citrate<br>* is a medication used to treat infertility in women who do not ovulate<br>* Other names: clomid;|
| Active Comparator: control group<br>clomiphene | Drug: Clomiphene Citrate<br>* is a medication used to treat infertility in women who do not ovulate<br>* Other names: clomid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovulation rate measure the number of patients who ovulate per cycle | Follicles measure more than 18 mm will be considered mature follicles. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pentoxifylline, alpha lipoic acid, polycystic ovary, clomiphene