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

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Resistant Ovary Syndrome; Clomiphene Citrate; Polycystic Ovary Syndrome

Treatments: Dietary Supplement: Alpha lipoic acid (ALA); Drug: Clomiphene Citrate; Drug: Pentoxifylline (PTX)

Study type: Interventional

Funder types: Other

Identifiers

NCT05231980

86

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Pentoxifylline (PTX) group

Experimental group

Description:

30 patients

Treatment:

Drug: Pentoxifylline (PTX)

Drug: Clomiphene Citrate

Alpha lipoic acid (ALA) group

Experimental group

Description:

30 patients

Treatment:

Drug: Clomiphene Citrate

Dietary Supplement: Alpha lipoic acid (ALA)

Combined PTX and ALA group

Experimental group

Description:

30 patients

Treatment:

Drug: Pentoxifylline (PTX)

Drug: Clomiphene Citrate

Dietary Supplement: Alpha lipoic acid (ALA)

control group

Active Comparator group

Description:

clomiphene

Treatment:

Drug: Clomiphene Citrate