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

July 19, 2023 updated by: Ahmed Abbas Morsy Morsy, Ain Shams University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banī Suwayf, Egypt, 62521
        • Medical Center of Infertility
      • Cairo, Egypt
        • College of Pharmacy Teaching Hospital Ainshams University
      • Giza, Egypt, 12573
        • Misr University For Sciences and Technology Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pentoxifylline (PTX) group
30 patients
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
Other Names:
  • trental
Drug: Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Other Names:
  • clomid
Experimental: Alpha lipoic acid (ALA) group
30 patients
Drug: Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Other Names:
  • clomid
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.
Other Names:
  • thiotacid
Experimental: Combined PTX and ALA group
30 patients
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
Other Names:
  • trental
Drug: Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Other Names:
  • clomid
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.
Other Names:
  • thiotacid
Active Comparator: control group
clomiphene
Drug: Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Other Names:
  • clomid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Misr University for Science and Technology

Investigators

  • Study Director: Nagwa Al Sabri, Phd, AinShams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2022

Primary Completion (Actual)

May 6, 2023

Study Completion (Actual)

June 7, 2023

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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