Infertility Treatment, Pregnancy Rates
Conditions
Keywords
Clomiphene citrate, Pioglitazone
Brief 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. 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.
Interventions
150 mg clomiphene citrate will be administered at third and seventh days of the menstrual cycle
DRUGPioglitazone (PIO) + Clomiphene citrate
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.
Sponsors
PAEC General Hospital, Islamabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovarian stimulation rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rates | 5th day after end of menstrual cycle | 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. |
Countries
Pakistan
Contacts
CONTACTKinza Principal Investigator, MBBS
STUDY_CHAIRMusarat Ashraf, MBBS,FCPS
Head of Department
Outcome results
None listed