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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05231980
Collaborator
Misr University for Science and Technology (Other)
120
2
4
8.8
60
6.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Alpha lipoic acid (ALA)
  • Drug: Pentoxifylline (PTX)
  • Drug: Clomiphene Citrate
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective randomized controlled open label studyprospective randomized controlled open label study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effect of Pentoxifylline and α-Lipoic Acid as Adjunctive Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Actual Study Start Date :
Jun 5, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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

    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
  • Drug: Clomiphene Citrate
    is a medication used to treat infertility in women who do not ovulate
    Other Names:
  • clomid
  • Experimental: Combined PTX and ALA group

    30 patients

    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
  • 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
  • Active Comparator: control group

    clomiphene

    Drug: Clomiphene Citrate
    is a medication used to treat infertility in women who do not ovulate
    Other Names:
  • clomid
  • Outcome Measures

    Primary Outcome Measures

    1. ovulation rate measure the number of patients who ovulate per cycle [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Center of Infertility Banī Suwayf Egypt 62521
    2 Misr University For Sciences and Technology Teaching Hospital Giza Egypt 12573

    Sponsors and Collaborators

    • Ain Shams University
    • Misr University for Science and Technology

    Investigators

    • Study Director: Nagwa Al Sabri, Phd, Ainshams university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Abbas Morsy Morsy, principal investigator, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05231980
    Other Study ID Numbers:
    • 86
    First Posted:
    Feb 9, 2022
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Abbas Morsy Morsy, principal investigator, Ain Shams University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2022