Clinical trial · Interventional
Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate
Evaluation of the Effect of Pentoxifylline and α-Lipoic Acid as Adjunctive Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome
NCT05231980CI-TRIAL-00068117completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluate the addition of PTX and ALA to clomiphene citrate in the treatment of polycystic ovary.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clomiphene Citrate | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Resistant Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha lipoic acid (ALA) | Dietary Supplement | — | UNRESOLVED |
| Clomiphene Citrate | Drug | — | UNRESOLVED |
| Pentoxifylline (PTX) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Pentoxifylline (PTX) group
- description
- 30 patients
- interventionNames
- Drug: Pentoxifylline (PTX)
- Drug: Clomiphene Citrate
- type
- EXPERIMENTAL
- label
- Alpha lipoic acid (ALA) group
- description
- 30 patients
- interventionNames
- Dietary Supplement: Alpha lipoic acid (ALA)
- Drug: Clomiphene Citrate
- type
- EXPERIMENTAL
- label
- Combined PTX and ALA group
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMorsy AA, Sabri NA, Mourad AM, Mojahed EM, Fahmy SF. New insights into pentoxifylline and alpha-lipoic acid: Co-administration with clomiphene citrate for ovulation induction in anovulatory women with polycystic ovary syndrome. Clin Exp Reprod Med. 2026 Mar;53(1):19-30. doi: 10.5653/cerm.2024.07346. Epub 2025 May 20. PMID 40393653