Clomiphene CitratePhase 2NCT05231980
Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate
A Phase 2 study testing Alpha lipoic acid (ALA), Pentoxifylline (PTX) and Clomiphene Citrate in people with Clomiphene Citrate and Resistant Ovary Syndrome, run by Ain Shams University at 3 sites in Egypt.
Trial summary
This study evaluate the addition of PTX and ALA to clomiphene citrate in the treatment of polycystic ovary. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Clomiphene Citrate, Resistant Ovary Syndrome, Polycystic Ovary Syndrome
- What is being tested?
- Alpha lipoic acid (ALA), Pentoxifylline (PTX) and Clomiphene Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesEgypt
- Study dates
- 5 Jun 2022to 7 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Medical Center of Infertility
Banī Suwayf, 62521
College of Pharmacy Teaching Hospital Ainshams University
Cairo
Misr University For Sciences and Technology Teaching Hospital
Giza, 12573
About this study
Official title: Evaluation of the Effect of Pentoxifylline and α-Lipoic Acid as Adjunctive Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome
This study evaluate the addition of PTX and ALA to clomiphene citrate in the treatment of polycystic ovary.
Read the 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.
- Being tested
- Alpha lipoic acid (ALA), Pentoxifylline (PTX), Clomiphene Citrate
- Keywords
- pentoxifylline, alpha lipoic acid, polycystic ovary, clomiphene
- Medical subject headings
- Primary Ovarian Insufficiency, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha lipoic acid (ALA)Dietary supplement
Also called thiotacid
ALA is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect.
Pentoxifylline (PTX)Drug
Also called trental
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
Clomiphene CitrateDrug
Also called clomid
is a medication used to treat infertility in women who do not ovulate
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline (PTX) group | Experimental | 30 patients Receives: Drug: Pentoxifylline (PTX); Drug: Clomiphene Citrate |
| Alpha lipoic acid (ALA) group | Experimental | 30 patients Receives: Dietary Supplement: Alpha lipoic acid (ALA); Drug: Clomiphene Citrate |
| Combined PTX and ALA group | Experimental | 30 patients Receives: Dietary Supplement: Alpha lipoic acid (ALA); Drug: Pentoxifylline (PTX); Drug: Clomiphene Citrate |
| control group | Active comparator | clomiphene Receives: Drug: Clomiphene Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovulation rate measure the number of patients who ovulate per cycle
Follicles measure more than 18 mm will be considered mature follicles.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start5 Jun 2022
- Primary completion6 May 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clomiphene CitrateStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled open label study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr University for Science and Technology
- Responsible party
- Principal investigator, Ahmed Abbas Morsy Morsy, Ain Shams University
- Investigators
- Nagwa Al Sabri, Phd, Study director, Ainshams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231980
- Sponsor's protocol ID
- 86
- Status last verified
- Jul 2023
- First submitted
- 31 Jan 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morsy 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.
PubMed 40393653
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Pentoxifylline and α-Lipoic Acid as Adjunctive Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05231980
- Acronym / sponsor ID
- 86
- Keywords
- pentoxifylline, alpha lipoic acid, polycystic ovary, clomiphene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Misr University for Science and Technology
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 6 May 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- prospective randomized controlled open label study
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline (PTX) group | Experimental | Drug: Pentoxifylline (PTX), Drug: Clomiphene Citrate30 patients |
| Alpha lipoic acid (ALA) group | Experimental | Dietary Supplement: Alpha lipoic acid (ALA), Drug: Clomiphene Citrate30 patients |
| Combined PTX and ALA group | Experimental | Dietary Supplement: Alpha lipoic acid (ALA), Drug: Pentoxifylline (PTX), Drug: Clomiphene Citrate30 patients |
| control group | Active comparator | Drug: Clomiphene Citrateclomiphene |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha lipoic acid (ALA)Also: thiotacidALA is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect. | Dietary supplement | Alpha lipoic acid (ALA) group, Combined PTX and ALA group |
| Pentoxifylline (PTX)Also: trentalPentoxifylline 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 | Drug | Combined PTX and ALA group, Pentoxifylline (PTX) group |
| Clomiphene CitrateAlso: clomidis a medication used to treat infertility in women who do not ovulate | Drug | Alpha lipoic acid (ALA) group, Combined PTX and ALA group, Pentoxifylline (PTX) group, control group |
Primary outcome
ovulation rate measure the number of patients who ovulate per cycle
Time frame: 3 months
Follicles measure more than 18 mm will be considered mature follicles.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 40393653Morsy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagwa Al Sabri, Phd study director
Ainshams university
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alpha lipoic acid (ALA), Pentoxifylline (PTX) and Clomiphene Citrate in people with Clomiphene Citrate and Resistant Ovary Syndrome, run by Ain Shams University at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ovulation rate measure the number of patients who ovulate per cycle (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05231980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.