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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

About this trial

This is an interventional treatment trial for Clomiphene Citrate focused on measuring pentoxifylline, alpha lipoic acid, polycystic ovary, clomiphene

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Active Comparator

Arm Label

Pentoxifylline (PTX) group

Alpha lipoic acid (ALA) group

Combined PTX and ALA group

control group

Arm Description

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

Learn more about this trial

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

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