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Could diabetes meds help women with PCOS get pregnant?

NCT ID NCT07589075

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding dapagliflozin (a diabetes drug) or metformin to the standard ovulation drug letrozole helps women with PCOS ovulate and become pregnant more often. 500 women aged 20-40 with PCOS and infertility took part. The goal was to see if these combinations improve ovulation and pregnancy rates compared to letrozole alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dapagliflozin and metformin (as add-on to letrozole)
What this could lead to
If successful, this approach could offer a new way to help women with PCOS ovulate and become pregnant more effectively.
What could go wrong
This is a completed phase 4 trial, but results are not yet published. The benefits may be modest, and side effects like urinary infections or gastrointestinal issues are possible with these drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

500 people

The number who actually took part.

Started

Oct 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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). Exclusion Criteria: 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. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Gynecology and Reproductive department in Beni-Suef University Hospital

    Banī Suwayf, 62517, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.