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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C | Active Comparator |
| |
| Group CP | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clomiphene Citrate. | Drug | 150 mg clomiphene citrate will be administered at third and seventh days of the menstrual cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10th day of menstrual cycle |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5th day after end of menstrual cycle |
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Inclusion Criteria:
Normal hysterosalpingography Normal spermogram Suffering from PCOS Ovarian cysts less than 20mm.
Exclusion Criteria:
History of chronic cardiovascular disease Chronic kidney disease Diabetes Thyroid disease Pulmonary disease
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kinza Principal Investigator, MBBS | Contact | +92-333-3275552 | kinza.azharr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Musarat Ashraf, MBBS,FCPS | Head of Department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pakistan Atomic Energy Commission Hospital | Recruiting | Islamabad | Federal | 44000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34404415 | Background | 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. |
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Ethical committee doesnt allow data sharing
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| ID | Term |
|---|---|
| D002996 | Clomiphene |
| D000077205 | Pioglitazone |
| D010389 | Pemoline |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Pioglitazone (PIO) + Clomiphene citrate | Drug | 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. |
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010080 | Oxazoles |