Clinical trial NCT05231980: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clomiphene Citrate
Resistant Ovary Syndrome
Polycystic Ovary Syndrome
Keywords: pentoxifylline
alpha lipoic acid
polycystic ovary
clomiphene
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Misr University for Science and Technology
First posted: 2022-02-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled open label study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ovulation rate measure the number of patients who ovulate per cycle
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Medical Center of Infertility
city: Cairo
country: Egypt
facility: College of Pharmacy Teaching Hospital Ainshams University
city: Giza
country: Egypt
facility: Misr University For Sciences and Technology Teaching Hospital
Study officials:
affiliation: Ainshams university
name: Nagwa Al Sabri, Phd
role: STUDY_DIRECTOR
References: