Polycystic Ovary SyndromePhase 3NCT06418347
Effect of ALA Combined With Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females
A Phase 3 study testing Alpha lipoic acid and Letrozole in people with Polycystic Ovary Syndrome and Infertility, Female, run by Ain Shams University at 1 site in Egypt.
Trial summary
This research study aims to investigate the effect of adding Alpha lipoic acid (ALA) supplement to letrozole treatment in infertile women with polycystic ovary syndrome (PCOS). The study will include 150 PCOS participants seeking fertility treatment. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Infertility, Female
- What is being tested?
- Alpha lipoic acid and Letrozole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 31 Aug 2025
- Phase
- Phase 3
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patient aged 18-35
- Willing to conceive
- PCOS, diagnosed according to the revised 2003 Rotterdam consensus criteria. " Oligo- or anovulation secondary to PCOS and at least one of the remaining two criteria: hyperandrogenism or polycystic ovarian morphology on ultrasound .
- Anovulation and/or infertility ≥ 1 year.
- At least one patent fallopian tube
- Normal uterine cavity
- Male partner with sperm concentration of at least 14 million/mL in at least one ejaculate.
Who cannot join
- Other causes for the infertility (male factor, tubal factor).
- Intake of hormonal or other drugs that can potentially influence the ovulation.
- Causes of anovulation or hyperandrogenism other than PCOS such as uncontrolled thyroid dysfunction or hyperprolactinemia.
- Contraindication to pregnancy
- Myo-inositol use \< 3 months prior to study enrollment
- Concomitant metformin use. Previous use is allowed with last use at least 6 weeks prior to randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Alpha-Lipoic Acid Supplementation on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females Treated With Letrozole
This research study aims to investigate the effect of adding Alpha lipoic acid (ALA) supplement to letrozole treatment in infertile women with polycystic ovary syndrome (PCOS). The study will include 150 PCOS participants seeking fertility treatment. They will be randomly divided into two groups - control and intervention. Both groups will receive standard PCOS care including lifestyle counseling. The control group will be treated with letrozole only. The dose will start at (2.5 mg) for 5 days and can increase up to (7.5 mg) based on response. The intervention group will take ALA supplements along with letrozole treatment. ALA tablets (600mg) will be given three times daily starting from day 3 of the menstrual cycle till human chorionic gonadotropin (HCG) injection day. Letrozole dose for the intervention group will also follow the same incremental protocol as the control group. Patient monitoring will involve trans-vaginal ultrasound scans on certain cycle days to check follicle growth and the thickness of uterus lining. Once a follicle reaches 18mm in size, an intramuscular HCG injection will be given. Couples will be asked to have intercourse 36 hours after the injection.
Pregnancy will be tested two weeks later if menstruation does not occur. Metabolic, hormonal, and ultrasound parameters will be recorded at baseline and follow-ups. All adverse effects of the treatment will be noted. The study period will be a maximum of 3 treatment cycles or untill pregnancy is achieved. Outcome measures include ovulation and pregnancy rates. The effect of ALA on metabolic parameters (fasting glucose, fasting insulin, BMI and HOMA-IR), hormone levels (mid-luteal progesterone and serum estradiol), and follicular growth will also be assessed. Proper sample size and randomization methods will be followed. A Statistical analysis of collected data will help determine if ALA has additional benefits when combined with letrozole for PCOS fertility treatment. Finally, the results will be statistically analyzed. Statistical analysis will be done using the SPSS statistical software package.
Read the detailed description
Eligible participants will be randomly allocated to the control group or the intervention group with a ratio of 1:1 after obtaining informed consent.
The two study groups will be as follows:
Control group: this group will include 75 PCOS participants who will receive the standard treatment letrozole and the other commonly provided PCOS care (lifestyle modification, diet and exercise education, any other non-pharmacological method of management) according to the PCOS guidelines.
Treatment with letrozole will begin after the baseline visit, and for three cycles, the administration will start after a spontaneous or progesterone-induced menstruation. In the first cycle, "2.5" mg letrozole will be taken for 5 days starting from day 3 to 7 of the menses, if no pregnancy was detected, letrozole dose will be increased to "5 mg" in the next cycle, and finally, "7.5 mg" letrozole will be administered during the third cycle if the patient is still unable to conceive.
Interventional group: this will include 75 PCOS participants who will receive the standard treatment as letrozole with the same schedule as the control group and the other commonly provided PCOS care as previously described in addition to ALA, (Thiotacid®, EVAPHARMA, Egypt) in a dose of one tablet "600 mg" three times per day Each patient in the test group will start the ALA from day 3 of the menstrual period, then daily until the day of human chorionic gonadotropin (HCG) injection.
Baseline assessment:
After enrollment, baseline data and demographics will be obtained from each participant including:
- Age and body mass index will be calculated in Kg/m^2.
- Serum FSH, LH, TSH, prolactin, androgens, including free and total testosterone and SHBG.
- Ultrasound measurements including antral-follicles count and detection of Polycystic ovaries "defined as either 12 or more follicles measuring 2 to 9 mm in diameter or an increased ovarian volume >10 cm^3.".
- Menstrual cyclicity, presence of first degree relatives with diabetes mellitus , smoking status, comorbidities, medication history .
- All subjects will be educated about their diet and physical activity, and they will be asked not to start any new medications during the study without informing the principal investigator.
Patients monitoring and follow-up. All the participants included in the study after a spontaneous or progesterone-induced menstrual cycle will be randomly assigned to either Control group or Interventional group and will be monitored by trans-vaginal ultrasound to assess follicular diameter and endometrial thickness on the 10th day of the cycle, then on 12th , 14th and the 20th days of the cycle for assessment of dominant follicle ( ≥ 18 mm) on TVUS. The number of dominant follicles and the endometrial thickness will be documented for each menstrual cycle.
- When at least one dominant follicle is detected, participants will receive an intramuscular injection of 10 000 IU human chorionic gonadotropin (HCG) (Choriomon, IBSA).
- An HCG injection will be given when at least one follicle measuring at least 18 mm is observed.
- Ovulation will also be confirmed by the evaluation of serum progesterone each cycle between cycle days 20-22 ( > 5 ng/mL) and the test will be repeated 1 week later if the initial progesterone level is below the threshold to confirm ovulation.
- Couples will be instructed to have timed intercourse 36 hours after the HCG injection.
- Serum HCG will be determined 2 weeks after HCG injection in the absence of menstruation for the detection of pregnancy.
- Pregnant women will be required to stop all medication.
- Patients who do not have any dominant follicles, will start a new ovulation induction cycle in the following month.
- Treatment of the next cycle will start if menses occurs either spontaneously or by induction. The first day of the menses is considered the first day of the cycle and this is repeated for up to a total of 3 treatment cycles.
- For those who fail to achieve a dominant follicle, alpha lipoic acid will be stopped and restarted in the next cycle as before.
- Conditions
- Polycystic Ovary Syndrome, Infertility, Female
- Being tested
- Alpha lipoic acid, Letrozole
- Keywords
- PCOS, ALA, Letrozole, Infertility, Ovulation rate
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha lipoic acidDrug
Also called ALA
Alpha-lipoic acid (ALA), also known as 1,2-dithiolane-3-pentanoic acid or thioctic acid, is found in the mitochondria. It acts as an enzymatic cofactor for various enzymes in the Kreb's cycle. ALA has many beneficial properties making it a potential candidate for various clinical disorders. It is considered the universal or "ideal" antioxidant as it is both water-soluble and fat-soluble facilitating its passage across membran. ALA has direct as well as indirect anti-inflammatory effects. Being a potent antioxidant leads to a reduction in oxidative stress which in turn reduces inflammation, meaning ALA indirectly has anti-inflammatory effects. To add to ALA's benefits, it has anti-inflammatory properties that are independent of its antioxidant effects.
LetrozoleDrug
Letrozole is an aromatase inhibitor that controls the conversion of androgen to estrogen and increases ovarian androgens. The administration of letrozole in the follicular phase removes the effect of negative estrogen feedback on the pituitary and hypothalamus, thus increasing the gonadotropins]. When Letrozole blocks estrogen production, it encourages the body to produce more follicle-stimulating hormone (FSH).The additional FSH stimulates egg development and increases the likelihood of ovulation. Kar, S. Found that letrozole has excellent pregnancy rates compared to clomiphene citrate, Letrozole should be considered at par with clomiphene citrate as first-line drug for ovulation induction in infertile PCOS women.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | This group will include 75 PCOS participants who will receive the standard treatment letrozole and the other commonly provided PCOS care (lifestyle modification, diet and exercise education, any other non-pharmacological method of management) according to the PCOS guidelines .Treatment with letrozole will begin after the baseline visit and for three cycles. Receives: Drug: Letrozole |
| Intervention | Experimental | this will include 75 PCOS participants who will receive the standard treatment as letrozole with the same schedule of the control group and the other commonly provided PCOS care as previously described in addition to ALA, (Thiotacid®, EVAPHARMA, Egypt) in a dose of one tablet "600 mg" three times per day Each patient in the test group will start the ALA from day 3 of the menstrual period then daily until the day of human chorionic gonadotropin (HCG) injection Receives: Drug: Alpha lipoic acid; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is cumulative ovulation rate
which is defined as the proportion of cycles in which ovulation occurred in the whole follow-up period.
Measured: 3 months
Secondary outcomes (8)
The clinical pregnancy rate
ultrasound visualization of one or more gestational sac with pulsating fetal pole
Measured: 3 months
BMI in kg/m^2
weight in kilograms, height in meters will be combined to report BMI in kg/m^2
Measured: 3 months
HOMA-IR
fasting insulin in (microU/L), fasting glucose in (nmol/L) will be combined to report HOMA-IR
Measured: 3 months
serum estradiol
Will be measure in (pg/ml)
Measured: 3 months
mid-luteal progesterone
Will be measured in (pg/ml)
Measured: 3 months
size of follicles
Will be measured in (mm)
Measured: 3 months
number of dominant follicles (≥18 mm)
Number of mature follicles in each ovary.
Measured: 3 months
endometrial thickness
Will be measured in (mm)
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 posted17 May 2024
- Study start1 Apr 2024
- Primary completion1 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418347
- Sponsor's protocol ID
- ALA on PCOS
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fruzzetti F, Benelli E, Fidecicchi T, Tonacchera M. Clinical and Metabolic Effects of Alpha-Lipoic Acid Associated with Two Different Doses of Myo-Inositol in Women with Polycystic Ovary Syndrome. Int J Endocrinol. 2020 Mar 19;2020:2901393. doi: 10.1155/2020/2901393. eCollection 2020.
PubMed 32256570Genazzani AD, Shefer K, Della Casa D, Prati A, Napolitano A, Manzo A, Despini G, Simoncini T. Modulatory effects of alpha-lipoic acid (ALA) administration on insulin sensitivity in obese PCOS patients. J Endocrinol Invest. 2018 May;41(5):583-590. doi: 10.1007/s40618-017-0782-z. Epub 2017 Oct 31.
PubMed 29090431Masharani U, Gjerde C, Evans JL, Youngren JF, Goldfine ID. Effects of controlled-release alpha lipoic acid in lean, nondiabetic patients with polycystic ovary syndrome. J Diabetes Sci Technol. 2010 Mar 1;4(2):359-64. doi: 10.1177/193229681000400218.
PubMed 20307398
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alpha-Lipoic Acid Supplementation on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females Treated With Letrozole
- ClinicalTrials.gov ID
- NCT06418347
- Acronym / sponsor ID
- ALA on PCOS
- Conditions
- Polycystic Ovary Syndrome, Infertility, Female
- Keywords
- PCOS, ALA, Letrozole, Infertility, Ovulation rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 17 May 2024 (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 research study aims to investigate the effect of adding Alpha lipoic acid (ALA) supplement to letrozole treatment in infertile women with polycystic ovary syndrome (PCOS). The study will include 150 PCOS participants seeking fertility treatment. They will be randomly divided into two groups - control and intervention. Both groups will receive standard PCOS care including lifestyle counseling. The control group will be treated with letrozole only. The dose will start at (2.5 mg) for 5 days and can increase up to (7.5 mg) based on response. The intervention group will take ALA supplements along with letrozole treatment. ALA tablets (600mg) will be given three times daily starting from day 3 of the menstrual cycle till human chorionic gonadotropin (HCG) injection day. Letrozole dose for the intervention group will also follow the same incremental protocol as the control group. Patient monitoring will involve trans-vaginal ultrasound scans on certain cycle days to check follicle growth and the thickness of uterus lining. Once a follicle reaches 18mm in size, an intramuscular HCG injection will be given. Couples will be asked to have intercourse 36 hours after the injection.
Pregnancy will be tested two weeks later if menstruation does not occur. Metabolic, hormonal, and ultrasound parameters will be recorded at baseline and follow-ups. All adverse effects of the treatment will be noted. The study period will be a maximum of 3 treatment cycles or untill pregnancy is achieved. Outcome measures include ovulation and pregnancy rates. The effect of ALA on metabolic parameters (fasting glucose, fasting insulin, BMI and HOMA-IR), hormone levels (mid-luteal progesterone and serum estradiol), and follicular growth will also be assessed. Proper sample size and randomization methods will be followed. A Statistical analysis of collected data will help determine if ALA has additional benefits when combined with letrozole for PCOS fertility treatment. Finally, the results will be statistically analyzed. Statistical analysis will be done using the SPSS statistical software package.
Detailed description
Eligible participants will be randomly allocated to the control group or the intervention group with a ratio of 1:1 after obtaining informed consent.
The two study groups will be as follows:
Control group: this group will include 75 PCOS participants who will receive the standard treatment letrozole and the other commonly provided PCOS care (lifestyle modification, diet and exercise education, any other non-pharmacological method of management) according to the PCOS guidelines.
Treatment with letrozole will begin after the baseline visit, and for three cycles, the administration will start after a spontaneous or progesterone-induced menstruation. In the first cycle, "2.5" mg letrozole will be taken for 5 days starting from day 3 to 7 of the menses, if no pregnancy was detected, letrozole dose will be increased to "5 mg" in the next cycle, and finally, "7.5 mg" letrozole will be administered during the third cycle if the patient is still unable to conceive.
Interventional group: this will include 75 PCOS participants who will receive the standard treatment as letrozole with the same schedule as the control group and the other commonly provided PCOS care as previously described in addition to ALA, (Thiotacid®, EVAPHARMA, Egypt) in a dose of one tablet "600 mg" three times per day Each patient in the test group will start the ALA from day 3 of the menstrual period, then daily until the day of human chorionic gonadotropin (HCG) injection.
Baseline assessment:
After enrollment, baseline data and demographics will be obtained from each participant including:
- Age and body mass index will be calculated in Kg/m^2.
- Serum FSH, LH, TSH, prolactin, androgens, including free and total testosterone and SHBG.
- Ultrasound measurements including antral-follicles count and detection of Polycystic ovaries "defined as either 12 or more follicles measuring 2 to 9 mm in diameter or an increased ovarian volume >10 cm^3.".
- Menstrual cyclicity, presence of first degree relatives with diabetes mellitus , smoking status, comorbidities, medication history .
- All subjects will be educated about their diet and physical activity, and they will be asked not to start any new medications during the study without informing the principal investigator.
Patients monitoring and follow-up. All the participants included in the study after a spontaneous or progesterone-induced menstrual cycle will be randomly assigned to either Control group or Interventional group and will be monitored by trans-vaginal ultrasound to assess follicular diameter and endometrial thickness on the 10th day of the cycle, then on 12th , 14th and the 20th days of the cycle for assessment of dominant follicle ( ≥ 18 mm) on TVUS. The number of dominant follicles and the endometrial thickness will be documented for each menstrual cycle.
- When at least one dominant follicle is detected, participants will receive an intramuscular injection of 10 000 IU human chorionic gonadotropin (HCG) (Choriomon, IBSA).
- An HCG injection will be given when at least one follicle measuring at least 18 mm is observed.
- Ovulation will also be confirmed by the evaluation of serum progesterone each cycle between cycle days 20-22 ( > 5 ng/mL) and the test will be repeated 1 week later if the initial progesterone level is below the threshold to confirm ovulation.
- Couples will be instructed to have timed intercourse 36 hours after the HCG injection.
- Serum HCG will be determined 2 weeks after HCG injection in the absence of menstruation for the detection of pregnancy.
- Pregnant women will be required to stop all medication.
- Patients who do not have any dominant follicles, will start a new ovulation induction cycle in the following month.
- Treatment of the next cycle will start if menses occurs either spontaneously or by induction. The first day of the menses is considered the first day of the cycle and this is repeated for up to a total of 3 treatment cycles.
- For those who fail to achieve a dominant follicle, alpha lipoic acid will be stopped and restarted in the next cycle as before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Drug: LetrozoleThis group will include 75 PCOS participants who will receive the standard treatment letrozole and the other commonly provided PCOS care (lifestyle modification, diet and exercise education, any other non-pharmacological method of management) according to the PCOS guidelines .Treatment with letrozole will begin after the baseline visit and for three cycles. |
| Intervention | Experimental | Drug: Alpha lipoic acid, Drug: Letrozolethis will include 75 PCOS participants who will receive the standard treatment as letrozole with the same schedule of the control group and the other commonly provided PCOS care as previously described in addition to ALA, (Thiotacid®, EVAPHARMA, Egypt) in a dose of one tablet "600 mg" three times per day Each patient in the test group will start the ALA from day 3 of the menstrual period then daily until the day of human chorionic gonadotropin (HCG) injection |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female patient aged 18-35
- Willing to conceive
- PCOS, diagnosed according to the revised 2003 Rotterdam consensus criteria. " Oligo- or anovulation secondary to PCOS and at least one of the remaining two criteria: hyperandrogenism or polycystic ovarian morphology on ultrasound .
- Anovulation and/or infertility ≥ 1 year.
- At least one patent fallopian tube
Key exclusion criteria (6 listed)
- Other causes for the infertility (male factor, tubal factor).
- Intake of hormonal or other drugs that can potentially influence the ovulation.
- Causes of anovulation or hyperandrogenism other than PCOS such as uncontrolled thyroid dysfunction or hyperprolactinemia.
- Contraindication to pregnancy
- Myo-inositol use \< 3 months prior to study enrollment
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 acidAlso: ALAAlpha-lipoic acid (ALA), also known as 1,2-dithiolane-3-pentanoic acid or thioctic acid, is found in the mitochondria. It acts as an enzymatic cofactor for various enzymes in the Kreb's cycle. ALA has many beneficial properties making it a potential candidate for various clinical disorders. It is considered the universal or "ideal" antioxidant as it is both water-soluble and fat-soluble facilitating its passage across membran. ALA has direct as well as indirect anti-inflammatory effects. Being a potent antioxidant leads to a reduction in oxidative stress which in turn reduces inflammation, meaning ALA indirectly has anti-inflammatory effects. To add to ALA's benefits, it has anti-inflammatory properties that are independent of its antioxidant effects. | Drug | Intervention |
| LetrozoleLetrozole is an aromatase inhibitor that controls the conversion of androgen to estrogen and increases ovarian androgens. The administration of letrozole in the follicular phase removes the effect of negative estrogen feedback on the pituitary and hypothalamus, thus increasing the gonadotropins]. When Letrozole blocks estrogen production, it encourages the body to produce more follicle-stimulating hormone (FSH).The additional FSH stimulates egg development and increases the likelihood of ovulation. Kar, S. Found that letrozole has excellent pregnancy rates compared to clomiphene citrate, Letrozole should be considered at par with clomiphene citrate as first-line drug for ovulation induction in infertile PCOS women. | Drug | Control, Intervention |
Primary outcome
The primary outcome is cumulative ovulation rate
Time frame: 3 months
which is defined as the proportion of cycles in which ovulation occurred in the whole follow-up period.
8 secondary outcomes
The clinical pregnancy rate
Time frame: 3 months
BMI in kg/m^2
Time frame: 3 months
HOMA-IR
Time frame: 3 months
serum estradiol
Time frame: 3 months
mid-luteal progesterone
Time frame: 3 months
size of follicles
Time frame: 3 months
number of dominant follicles (≥18 mm)
Time frame: 3 months
endometrial thickness
Time frame: 3 months
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 16 Sep 2026.
- Background: PubMed 32256570Fruzzetti F, Benelli E, Fidecicchi T, Tonacchera M. Clinical and Metabolic Effects of Alpha-Lipoic Acid Associated with Two Different Doses of Myo-Inositol in Women with Polycystic Ovary Syndrome. Int J Endocrinol. 2020 Mar 19;2020:2901393. doi: 10.1155/2020/2901393. eCollection 2020.
- Background: PubMed 29090431Genazzani AD, Shefer K, Della Casa D, Prati A, Napolitano A, Manzo A, Despini G, Simoncini T. Modulatory effects of alpha-lipoic acid (ALA) administration on insulin sensitivity in obese PCOS patients. J Endocrinol Invest. 2018 May;41(5):583-590. doi: 10.1007/s40618-017-0782-z. Epub 2017 Oct 31.
- Background: PubMed 20307398Masharani U, Gjerde C, Evans JL, Youngren JF, Goldfine ID. Effects of controlled-release alpha lipoic acid in lean, nondiabetic patients with polycystic ovary syndrome. J Diabetes Sci Technol. 2010 Mar 1;4(2):359-64. doi: 10.1177/193229681000400218.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alpha lipoic acid and Letrozole in people with Polycystic Ovary Syndrome and Infertility, Female, run by Ain Shams University at 1 site 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 7 inclusion and 6 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary outcome is cumulative ovulation rate (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 NCT06418347, which also lists 3 linked publications.
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 16 Sep 2026.