Induction of OvulationPhase 4SGLT-2/PCOSNCT07589075
Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy With Letrozole in Induction of Ovulation in Women With Polycystic Ovarian Syndrome
A Phase 4 study testing Metformin 1000 mg Oral Tablet, Dapagliflozin 10 MG Oral Tablet [Farxiga] and Combined Dapagliflozin-Metformin 5/1000mg in people with Induction of Ovulation and PCO - Polycystic Ovaries, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Ovulation, PCO - Polycystic Ovaries
- What is being tested?
- Metformin 1000 mg Oral Tablet, Dapagliflozin 10 MG Oral Tablet [Farxiga] and Combined Dapagliflozin-Metformin 5/1000mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2023to 30 Oct 2025
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pre-menopausal women aged 20-40 with primary or secondary infertility and PCOS which render them unable to become pregnant. Diagnosis of PCOS will based on European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM) criteria, the diagnosis is made when at least two of the following criteria are met: oilgo and/or anovulation (infrequent or no ovulation), clinical and/or biochemical signs of hyperandrogenism including hirsutism, acne and/or increased testosterone levels or polycystic ovaries on ultrasound (defined as those containing at least 12 follicles measuring 2-9 mm in diameter arranged peripherally around an echo-dense stroma and/or with increased ovarian volume of at least 10 ml).
Who cannot join
- Other causes of hyperandrogenism mimic PCOS such as congenital adrenal hyperplasia, Cushing's syndrome, or androgen secreting tumors are excluded.
- Persistent hyperprolactinemia, thyroid dysfunction defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL) or patients with menopausal levels of FSH (> 15 mIU/mL) (A normal level within the last year is adequate for enter the study).
- Liver disease is defined as AST or ALT > 2 times normal or total bilirubin >2.5 mg/dL, kidney disease defined as BUN > 30 mg/dL or serum creatinine> 1.4 mg/dL or significant anemia defined as Hemoglobin < 10 mg/dL.
- Women with Type I or II diabetes mellitus who are poorly controlled (defined as a HA1c level > 7.0%).
- Untreated poorly controlled hypertension is defined as a systolic blood pressure ≥ 160 mm Hg or a diastolic ≥ 100 mm Hg obtained on two measures obtained at least 60 minutes apart.
- History of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident.
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- Women who have undergone a bariatric surgery procedure in the recent past (<12 months) and are in a period of acute weight loss or have been advised against pregnancy by their bariatric surgeon.
- Presence of any urinary symptom such as frequency, urgency, or bloody micturition.
- In case of metabolic acidosis, osteoporosis, endometrial hyperplasia, or endometrial neoplasia.
- Women who had gonadotropin induction, ovarian drilling before or women with hypergonadotropic hypogonadism or functional ovarian cysts (> 5cm).
- Criteria of IVF/ICSI as poor Response, no Eggs or ectopic pregnancy. Women who receive antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas are likely to confound the effects of study medication or who are currently receiving metformin XR for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded.
- Concomitant use of medication that could interfere with the absorption, metabolism, and excretion of drugs involved in the study as the use of Furosemide, cimetidine increase metformin concentration and nifedipine enhances the absorption of metformin.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Gynecology and Reproductive department in Beni-Suef University Hospital
Banī Suwayf, 62517
About this study
The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy.
Read the detailed description
The study will be a randomized controlled clinical trial. Once the eligibility from screening visit is determined prior to baseline visit, randomization will be made by computer randomization for women who are admitted to Beni-Suef University Hospital. The Sample size will be 500 divided equally into 4 groups calculated with power=0.8.
Before initiation of the study, the population will be divided randomly into 4 equal groups: group A, B, C and D. The adjuvant therapy of each group will be group (A) Metformin , group (B) Dapagliflozin , Group(C) Combined Dapagliflozin-Metformin and group (D) with no adjuvant therapy (control group). The adjuvant therapy will be taken once daily with a main meal and started one month before initiation of letrozole. All groups will take letrozole 2.5mg twice daily from the third day of the cycle for 5 days.
Ovulation rate (percentage of ovulatory cycles in the whole follow up period),Pregnancy rate (clinical pregnancy will be considered when an intrauterine gestational sac is seen and presence of a fetal heartbeat),Serum progesterone on day 21,Endometrial thickness at the time of ovulation and Weight, waist/hip ratio, height and body mass index (BMI) will be measured
- Conditions
- Induction of Ovulation, PCO - Polycystic Ovaries
- Being tested
- Metformin 1000 mg Oral Tablet, Dapagliflozin 10 MG Oral Tablet [Farxiga], Combined Dapagliflozin-Metformin 5/1000mg, Letrozole 2.5Mg Tablet
- Keywords
- Polycystic Ovarian Syndrome, Induction of Ovulation, Sodium-Glucose Co-Transporter-2 Inhibitors, Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy with Letrozole in Induction of Ovulation, Adjuvant Therapy with Letrozole in Induction of Ovulation in Women with Polycystic Ovarian Syndrome, Adjuvant Therapy with Letrozole, Letrozole in Induction of Ovulation in Women with Polycystic Ovarian Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 1000 mg Oral TabletDrug
will take Metformin 1000 mg once daily with a main meal and started one month before initiation of the first cycle of induction.
Dapagliflozin 10 MG Oral Tablet [Farxiga]Drug
will take Dapagliflozin 10mg once daily with a main meal and started one month before initiation of the first cycle of induction.
Combined Dapagliflozin-Metformin 5/1000mgDrug
will take Combined Dapagliflozin-Metformin 5/1000mg once daily with a main meal and started one month before initiation of the first cycle of induction.
Letrozole 2.5Mg TabletDrug
will take letrozole 2.5mg twice daily from the third day of the cycle for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| "metformin" | Experimental | will take Metformin 1000mg as adjuvant therapy+Letrozole2.5mg Receives: Drug: Metformin 1000 mg Oral Tablet; Drug: Letrozole 2.5Mg Tablet |
| "Dapagliflozin" | Experimental | will take Dapagliflozin 10mg as adjuvant therapy+Letrozole2.5mg Receives: Drug: Dapagliflozin 10 MG Oral Tablet [Farxiga]; Drug: Letrozole 2.5Mg Tablet |
| "Dapagliflozin-Metformin" | Experimental | will take combined Dapagliflozin-Metformin 5/1000 as adjuvant therapy+Letrozole2.5mg Receives: Drug: Combined Dapagliflozin-Metformin 5/1000mg; Drug: Letrozole 2.5Mg Tablet |
| "control" | Other | will take letrozole 2.5mg without adjuvant therapy Receives: Drug: Letrozole 2.5Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
percentage of ovulatory cycles
Measured: "through study completion, an average of 1 year".
Pregnancy rate
when an intrauterine gestational sac is seen and presence of a fetal heartbeat)
Measured: "through study completion, an average of 1 year".
Secondary outcomes (1)
Serum progesterone
Serum progesterone
Measured: "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start20 Oct 2023
- Primary completion1 Jul 2024
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of OvulationStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Thabet Farag Ahmed Sakran, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589075
- Sponsor's protocol ID
- IORG2226240
- Acronym
- SGLT-2/PCOS
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy With Letrozole in Induction of Ovulation in Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT07589075
- Acronym / sponsor ID
- SGLT-2/PCOS / IORG2226240
- Conditions
- Induction of Ovulation, PCO - Polycystic Ovaries
- Keywords
- Polycystic Ovarian Syndrome, Induction of Ovulation, Sodium-Glucose Co-Transporter-2 Inhibitors, Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy with Letrozole in Induction of Ovulation, Adjuvant Therapy with Letrozole in Induction of Ovulation in Women with Polycystic Ovarian Syndrome, Adjuvant Therapy with Letrozole, Letrozole in Induction of Ovulation in Women with Polycystic Ovarian Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 15 May 2026 (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.
The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy.
Detailed description
The study will be a randomized controlled clinical trial. Once the eligibility from screening visit is determined prior to baseline visit, randomization will be made by computer randomization for women who are admitted to Beni-Suef University Hospital. The Sample size will be 500 divided equally into 4 groups calculated with power=0.8.
Before initiation of the study, the population will be divided randomly into 4 equal groups: group A, B, C and D. The adjuvant therapy of each group will be group (A) Metformin , group (B) Dapagliflozin , Group(C) Combined Dapagliflozin-Metformin and group (D) with no adjuvant therapy (control group). The adjuvant therapy will be taken once daily with a main meal and started one month before initiation of letrozole. All groups will take letrozole 2.5mg twice daily from the third day of the cycle for 5 days.
Ovulation rate (percentage of ovulatory cycles in the whole follow up period),Pregnancy rate (clinical pregnancy will be considered when an intrauterine gestational sac is seen and presence of a fetal heartbeat),Serum progesterone on day 21,Endometrial thickness at the time of ovulation and Weight, waist/hip ratio, height and body mass index (BMI) will be measured
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| "metformin" | Experimental | Drug: Metformin 1000 mg Oral Tablet, Drug: Letrozole 2.5Mg Tabletwill take Metformin 1000mg as adjuvant therapy+Letrozole2.5mg |
| "Dapagliflozin" | Experimental | Drug: Dapagliflozin 10 MG Oral Tablet [Farxiga], Drug: Letrozole 2.5Mg Tabletwill take Dapagliflozin 10mg as adjuvant therapy+Letrozole2.5mg |
| "Dapagliflozin-Metformin" | Experimental | Drug: Combined Dapagliflozin-Metformin 5/1000mg, Drug: Letrozole 2.5Mg Tabletwill take combined Dapagliflozin-Metformin 5/1000 as adjuvant therapy+Letrozole2.5mg |
| "control" | Other | Drug: Letrozole 2.5Mg Tabletwill take letrozole 2.5mg without adjuvant therapy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pre-menopausal women aged 20-40 with primary or secondary infertility and PCOS which render them unable to become pregnant. Diagnosis of PCOS will based on European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM) criteria, the diagnosis is made when at least two of the following criteria are met: oilgo and/or anovulation (infrequent or no ovulation), clinical and/or biochemical signs of hyperandrogenism including hirsutism, acne and/or increased testosterone levels or polycystic ovaries on ultrasound (defined as those containing at least 12 follicles measuring 2-9 mm in diameter arranged peripherally around an echo-dense stroma and/or with increased ovarian volume of at least 10 ml).
Key exclusion criteria (12 listed)
- Other causes of hyperandrogenism mimic PCOS such as congenital adrenal hyperplasia, Cushing's syndrome, or androgen secreting tumors are excluded.
- Persistent hyperprolactinemia, thyroid dysfunction defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL) or patients with menopausal levels of FSH (> 15 mIU/mL) (A normal level within the last year is adequate for enter the study).
- Liver disease is defined as AST or ALT > 2 times normal or total bilirubin >2.5 mg/dL, kidney disease defined as BUN > 30 mg/dL or serum creatinine> 1.4 mg/dL or significant anemia defined as Hemoglobin < 10 mg/dL.
- Women with Type I or II diabetes mellitus who are poorly controlled (defined as a HA1c level > 7.0%).
- Untreated poorly controlled hypertension is defined as a systolic blood pressure ≥ 160 mm Hg or a diastolic ≥ 100 mm Hg obtained on two measures obtained at least 60 minutes apart.
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 |
|---|---|---|
| Metformin 1000 mg Oral Tabletwill take Metformin 1000 mg once daily with a main meal and started one month before initiation of the first cycle of induction. | Drug | "metformin" |
| Dapagliflozin 10 MG Oral Tablet [Farxiga]will take Dapagliflozin 10mg once daily with a main meal and started one month before initiation of the first cycle of induction. | Drug | "Dapagliflozin" |
| Combined Dapagliflozin-Metformin 5/1000mgwill take Combined Dapagliflozin-Metformin 5/1000mg once daily with a main meal and started one month before initiation of the first cycle of induction. | Drug | "Dapagliflozin-Metformin" |
| Letrozole 2.5Mg Tabletwill take letrozole 2.5mg twice daily from the third day of the cycle for 5 days. | Drug | "Dapagliflozin", "Dapagliflozin-Metformin", "control", "metformin" |
Primary outcome
Ovulation rate
Time frame: "through study completion, an average of 1 year".
percentage of ovulatory cycles
Pregnancy rate
Time frame: "through study completion, an average of 1 year".
when an intrauterine gestational sac is seen and presence of a fetal heartbeat)
1 secondary outcome
Serum progesterone
Time frame: "through study completion, an average of 1 year".
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 6 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Induction of Ovulation
Recruiting
LE + CC vs. LE for Ovulation Induction
Letrozole, Clomiphene Citrate
Not yet recruiting
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Infertility, Female, Ovulation Induction
RecruitingPhase 1
E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study
Poly Cystic Ovary Syndrome
RecruitingPhase 4
Progesterone Supplementation After Letrozole-stimulated Insemination
Infertility
RecruitingPhase 2/3
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
Poor Response to Ovulation Induction, Infertility, Female
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 4 study testing Metformin 1000 mg Oral Tablet, Dapagliflozin 10 MG Oral Tablet [Farxiga] and Combined Dapagliflozin-Metformin 5/1000mg in people with Induction of Ovulation and PCO - Polycystic Ovaries, run by Beni-Suef 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 1 inclusion and 12 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 6 Oct 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (time frame: "through study completion, an average of 1 year".). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.