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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05231980
• Other study ID #: 86
• Status: Completed
• Phase: Phase 2
• Start date: June 5, 2022
• Est. completion date: June 7, 2023

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 7, 2023
• Est. primary completion date: May 6, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clomiphene Citrate
• Polycystic Ovary Syndrome
• Primary Ovarian Insufficiency
• Syndrome

Intervention

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.

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
• Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate

Locations

Country	Name	City	State
Egypt	Medical Center of Infertility	Bani Suwayf
Egypt	College of Pharmacy Teaching Hospital Ainshams University	Cairo
Egypt	Misr University For Sciences and Technology Teaching Hospital	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Misr University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ovulation rate measure the number of patients who ovulate per cycle	Follicles measure more than 18 mm will be considered mature follicles.	3 months