Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate
Primary Purpose
Clomiphene Citrate, Resistant Ovary Syndrome, Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Alpha lipoic acid (ALA)
Pentoxifylline (PTX)
Clomiphene Citrate
Sponsored by
About this trial
This is an interventional treatment trial for Clomiphene Citrate focused on measuring pentoxifylline, alpha lipoic acid, polycystic ovary, clomiphene
Eligibility Criteria
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.
Sites / Locations
- Medical Center of Infertility
- College of Pharmacy Teaching Hospital Ainshams University
- Misr University For Sciences and Technology Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Pentoxifylline (PTX) group
Alpha lipoic acid (ALA) group
Combined PTX and ALA group
control group
Arm Description
30 patients
30 patients
30 patients
clomiphene
Outcomes
Primary Outcome Measures
ovulation rate measure the number of patients who ovulate per cycle
Follicles measure more than 18 mm will be considered mature follicles.
Secondary Outcome Measures
Full Information
NCT ID
NCT05231980
First Posted
January 31, 2022
Last Updated
July 19, 2023
Sponsor
Ain Shams University
Collaborators
Misr University for Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05231980
Brief Title
Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate
Official Title
Evaluation of the Effect of Pentoxifylline and α-Lipoic Acid as Adjunctive Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2022 (Actual)
Primary Completion Date
May 6, 2023 (Actual)
Study Completion Date
June 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Misr University for Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluate the addition of PTX and ALA to clomiphene citrate in the treatment of polycystic ovary.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clomiphene Citrate, Resistant Ovary Syndrome, Polycystic Ovary Syndrome
Keywords
pentoxifylline, alpha lipoic acid, polycystic ovary, clomiphene
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled open label study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pentoxifylline (PTX) group
Arm Type
Experimental
Arm Description
30 patients
Arm Title
Alpha lipoic acid (ALA) group
Arm Type
Experimental
Arm Description
30 patients
Arm Title
Combined PTX and ALA group
Arm Type
Experimental
Arm Description
30 patients
Arm Title
control group
Arm Type
Active Comparator
Arm Description
clomiphene
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha lipoic acid (ALA)
Other Intervention Name(s)
thiotacid
Intervention Description
ALA is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect.
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline (PTX)
Other Intervention Name(s)
trental
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate
Other Intervention Name(s)
clomid
Intervention Description
is a medication used to treat infertility in women who do not ovulate
Primary Outcome Measure Information:
Title
ovulation rate measure the number of patients who ovulate per cycle
Description
Follicles measure more than 18 mm will be considered mature follicles.
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagwa Al Sabri, Phd
Organizational Affiliation
Ainshams university
Official's Role
Study Director
Facility Information:
Facility Name
Medical Center of Infertility
City
Banī Suwayf
ZIP/Postal Code
62521
Country
Egypt
Facility Name
College of Pharmacy Teaching Hospital Ainshams University
City
Cairo
Country
Egypt
Facility Name
Misr University For Sciences and Technology Teaching Hospital
City
Giza
ZIP/Postal Code
12573
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate
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