Status:
COMPLETED
Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate
Lead Sponsor:
Ain Shams University
Collaborating Sponsors:
Misr University for Science and Technology
Conditions:
Clomiphene Citrate
Resistant Ovary Syndrome
Eligibility:
FEMALE
18-39 years
Phase:
PHASE2
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 causin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05231980
Start Date
June 5 2022
End Date
June 7 2023
Last Update
July 20 2023
Active Locations (3)
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1
Medical Center of Infertility
Banī Suwayf, Egypt, 62521
2
College of Pharmacy Teaching Hospital Ainshams University
Cairo, Egypt
3
Misr University For Sciences and Technology Teaching Hospital
Giza, Egypt, 12573