Clomiphene Citrate, Polycystic Ovary Syndrome, Resistant Ovary Syndrome
Conditions
Keywords
pentoxifylline, alpha lipoic acid, polycystic ovary, clomiphene
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.
Interventions
DIETARY_SUPPLEMENTAlpha 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.
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
DRUGClomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Sponsors
Misr University for Science and Technology
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective randomized controlled open label study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ovulation rate measure the number of patients who ovulate per cycle | 3 months | Follicles measure more than 18 mm will be considered mature follicles. |
Countries
Egypt
Outcome results
None listed