Infertility TreatmentPhase 4NCT07462065
Effect Clomiphene vs Clomiphene Along With Pioglitazone on Ovarian Stimulation Rate
A Phase 4 study testing Clomiphene Citrate. and Pioglitazone (PIO) + Clomiphene citrate in people with Infertility Treatment and Pregnancy Rates, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
Trial summary
Women who meet the study requirements will be enrolled and randomly assigned by a computer system to receive either pioglitazone 30 mg daily or a placebo starting from the second day of their menstrual period for the same duration. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Treatment, Pregnancy Rates
- What is being tested?
- Clomiphene Citrate. and Pioglitazone (PIO) + Clomiphene citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2026to 1 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal hysterosalpingography Normal spermogram Suffering from PCOS Ovarian cysts less than 20mm.
Who cannot join
- History of chronic cardiovascular disease Chronic kidney disease Diabetes Thyroid disease Pulmonary disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Atomic Energy Commission Hospital
Islamabad, Federal, 44000
Ayesha Tariq, MBBS, aaysha1972@hotmail.com
About this study
Official title: Comparison of Clomiphene Citrate vs Clomiphene Citrate in Combination With Pioglitazone in Terms of Ovarian Stimulation and Pregnancy Rates Among Infertile Women Suffering From Polycystic Ovarian Syndrome
Women who meet the study requirements will be enrolled and randomly assigned by a computer system to receive either pioglitazone 30 mg daily or a placebo starting from the second day of their menstrual period for the same duration. All participants will also take clomiphene citrate 150 mg daily from day 3 to day 7 of the menstrual cycle. A transvaginal ultrasound will be performed on day 10 of the menstrual cycle to assess the growth of ovarian follicles, and the number of mature follicles (16-24 mm) will be recorded. If at least one mature follicle measuring 16-24 mm is present and the endometrial thickness is at least 7 mm, an injection of human chorionic gonadotropin (hCG) will be given to trigger ovulation, followed by an intrauterine insemination (IUI) procedure. Participants will be followed until the end of the menstrual cycle, and if the menstrual period is delayed by 5 days, a blood test for β-hCG will be performed to confirm pregnancy. Any side effects during the treatment period, such as swelling, fluid retention, blurred vision, or weight gain, will be recorded.
Read the detailed description
Patients fulfilling the inclusion criteria will be enrolled and randomized using computer-generated random numbers to receive either pioglitazone 30 mg daily or a placebo starting from the second day of menstruation for a similar duration. All participants will receive clomiphene citrate 150 mg between the third and seventh days of the menstrual cycle. Transvaginal sonography will be performed on the 10th day of the menstrual cycle, and the number of large follicles (16-24 mm) will be recorded. Human chorionic gonadotropin (hCG) will be administered to patients with at least one follicle measuring 16-24 mm and an endometrial thickness of at least 7 mm, followed by intrauterine insemination (IUI). Patients will be followed until the end of the menstrual cycle, and in cases of a 5-day delay in menstruation, a blood sample will be obtained to measure β-hCG for biochemical confirmation of pregnancy. Any adverse effects observed during the treatment period, including edema, fluid retention, blurred vision, or weight gain, will be documented.
- Conditions
- Infertility Treatment, Pregnancy Rates
- Being tested
- Clomiphene Citrate., Pioglitazone (PIO) + Clomiphene citrate
- Keywords
- Clomiphene citrate, Pioglitazone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene Citrate.Drug
150 mg clomiphene citrate will be administered at third and seventh days of the menstrual cycle
Pioglitazone (PIO) + Clomiphene citrateDrug
Patients will receive 30 mg pioglitazone daily; from the second day of menstruation along with 150 mg clomiphene citrate will be administered to both groups between the third and seventh days of the menstrual cycle.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | Not described Receives: Drug: Clomiphene Citrate. |
| Group CP | Active comparator | Not described Receives: Drug: Pioglitazone (PIO) + Clomiphene citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian stimulation rate
This will be determined by no. of large size follicles (16-24mm in size) recruited following treatment on 10th day of menstrual cycle using transvaginal ultrasound to measure the size and no. of follicles.
Measured: 10th day of menstrual cycle
Secondary outcomes (1)
Pregnancy rates
It will be measured in terms of number of patients out of total number treated who conceived. This will be confirmed clinically as well as by measuring serum bHCG levels if patient doesn't not menstruate for more than 5 days following end of her reproductive cycle.
Measured: 5th day after end of menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
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 Infertility TreatmentStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PAEC General Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kinza Azhar, PAEC General Hospital, Islamabad
- Investigators
- Musarat Ashraf, MBBS,FCPS, Study chair, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462065
- Sponsor's protocol ID
- PGHI-IRB (DMe)-RCD-06-098
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical committee doesnt allow data sharing
Publications
Amirian M, Shariat Moghani S, Jafarian F, Mirteimouri M, Nikdoust S, Niroumand S, Salehi M, Payrovnaziri A. Combination of pioglitazone and clomiphene citrate versus clomiphene citrate alone for infertile women with the polycystic ovarian syndrome. BMC Womens Health. 2021 Aug 17;21(1):302. doi: 10.1186/s12905-021-01448-5.
PubMed 34404415
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clomiphene Citrate vs Clomiphene Citrate in Combination With Pioglitazone in Terms of Ovarian Stimulation and Pregnancy Rates Among Infertile Women Suffering From Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT07462065
- Acronym / sponsor ID
- PGHI-IRB (DMe)-RCD-06-098
- Conditions
- Infertility Treatment, Pregnancy Rates
- Keywords
- Clomiphene citrate, Pioglitazone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- PAEC General Hospital, IslamabadUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Mar 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.
Women who meet the study requirements will be enrolled and randomly assigned by a computer system to receive either pioglitazone 30 mg daily or a placebo starting from the second day of their menstrual period for the same duration. All participants will also take clomiphene citrate 150 mg daily from day 3 to day 7 of the menstrual cycle. A transvaginal ultrasound will be performed on day 10 of the menstrual cycle to assess the growth of ovarian follicles, and the number of mature follicles (16-24 mm) will be recorded. If at least one mature follicle measuring 16-24 mm is present and the endometrial thickness is at least 7 mm, an injection of human chorionic gonadotropin (hCG) will be given to trigger ovulation, followed by an intrauterine insemination (IUI) procedure. Participants will be followed until the end of the menstrual cycle, and if the menstrual period is delayed by 5 days, a blood test for β-hCG will be performed to confirm pregnancy. Any side effects during the treatment period, such as swelling, fluid retention, blurred vision, or weight gain, will be recorded.
Detailed description
Patients fulfilling the inclusion criteria will be enrolled and randomized using computer-generated random numbers to receive either pioglitazone 30 mg daily or a placebo starting from the second day of menstruation for a similar duration. All participants will receive clomiphene citrate 150 mg between the third and seventh days of the menstrual cycle. Transvaginal sonography will be performed on the 10th day of the menstrual cycle, and the number of large follicles (16-24 mm) will be recorded. Human chorionic gonadotropin (hCG) will be administered to patients with at least one follicle measuring 16-24 mm and an endometrial thickness of at least 7 mm, followed by intrauterine insemination (IUI). Patients will be followed until the end of the menstrual cycle, and in cases of a 5-day delay in menstruation, a blood sample will be obtained to measure β-hCG for biochemical confirmation of pregnancy. Any adverse effects observed during the treatment period, including edema, fluid retention, blurred vision, or weight gain, will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Drug: Clomiphene Citrate. |
| Group CP | Active comparator | Drug: Pioglitazone (PIO) + Clomiphene citrate |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal hysterosalpingography Normal spermogram Suffering from PCOS Ovarian cysts less than 20mm.
Key exclusion criteria (1 listed)
- History of chronic cardiovascular disease Chronic kidney disease Diabetes Thyroid disease Pulmonary disease
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 |
|---|---|---|
| Clomiphene Citrate.150 mg clomiphene citrate will be administered at third and seventh days of the menstrual cycle | Drug | Group C |
| Pioglitazone (PIO) + Clomiphene citratePatients will receive 30 mg pioglitazone daily; from the second day of menstruation along with 150 mg clomiphene citrate will be administered to both groups between the third and seventh days of the menstrual cycle. | Drug | Group CP |
Primary outcome
Ovarian stimulation rate
Time frame: 10th day of menstrual cycle
This will be determined by no. of large size follicles (16-24mm in size) recruited following treatment on 10th day of menstrual cycle using transvaginal ultrasound to measure the size and no. of follicles.
1 secondary outcome
Pregnancy rates
Time frame: 5th day after end of menstrual cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 34404415Amirian M, Shariat Moghani S, Jafarian F, Mirteimouri M, Nikdoust S, Niroumand S, Salehi M, Payrovnaziri A. Combination of pioglitazone and clomiphene citrate versus clomiphene citrate alone for infertile women with the polycystic ovarian syndrome. BMC Womens Health. 2021 Aug 17;21(1):302. doi: 10.1186/s12905-021-01448-5.
- Individual participant dataSharing planned: No. Ethical committee doesnt allow data sharing
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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.
Musarat Ashraf, MBBS,FCPS study chair
Head of Department
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 Clomiphene Citrate. and Pioglitazone (PIO) + Clomiphene citrate in people with Infertility Treatment and Pregnancy Rates, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
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 1 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: looking for participants now, as of the sponsor's last update on 10 Mar 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kinza Principal Investigator, MBBS (+92-333-3275552, kinza.azharr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian stimulation rate (time frame: 10th day of menstrual cycle). 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 NCT07462065, 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 10 Mar 2026.