Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate
Study Details
Study Description
Brief Summary
This study evaluate the addition of PTX and ALA to clomiphene citrate in the treatment of polycystic ovary.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Pentoxifylline (PTX) group 30 patients |
Drug: 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
Other Names:
Drug: Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Other Names:
|
Experimental: Alpha lipoic acid (ALA) group 30 patients |
Dietary Supplement: 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.
Other Names:
Drug: Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Other Names:
|
Experimental: Combined PTX and ALA group 30 patients |
Dietary Supplement: 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.
Other Names:
Drug: 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
Other Names:
Drug: Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Other Names:
|
Active Comparator: control group clomiphene |
Drug: Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Other Names:
|
Outcome Measures
Primary Outcome Measures
- ovulation rate measure the number of patients who ovulate per cycle [3 months]
Follicles measure more than 18 mm will be considered mature follicles.
Eligibility Criteria
Criteria
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.
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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.
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Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency.
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Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date.
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Male factor infertility (sperm count < 5 million per milliliter, normal morphology <4%).
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Elevated serum prolactin, T.S.H and F.S.H.
-
Patients diagnosed with diabetes mellitus
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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.
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Patients with acute myocardial infraction, severe coronary artery disease.
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Patients with hemorrhage or at risk of increased bleeding and Patients with peptic ulcers.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Medical Center of Infertility | Banī Suwayf | Egypt | 62521 | |
2 | Misr University For Sciences and Technology Teaching Hospital | Giza | Egypt | 12573 |
Sponsors and Collaborators
- Ain Shams University
- Misr University for Science and Technology
Investigators
- Study Director: Nagwa Al Sabri, Phd, Ainshams university
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 86