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NCT Number: NCT05231980

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

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

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Key information

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Medical Center of Infertility, Banī Suwayf, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • 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.

Treatment and study plan

Alpha lipoic acid (ALA)

Dietary Supplement

ALA is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect.

Other names: thiotacid

Pentoxifylline (PTX)

Drug

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: trental

Clomiphene Citrate

Drug

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

Other names: clomid

Primary outcomes

  1. ovulation rate measure the number of patients who ovulate per cycle

    Time frame: 3 months

    Follicles measure more than 18 mm will be considered mature follicles.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Misr University for Science and Technology

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2022
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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