Effect Clomiphene vs Clomiphene Along With Pioglitazone on Ovarian Stimulation Rate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clomiphene Citrate., Pioglitazone (PIO) + Clomiphene citrate.
- Who it may be relevant to
- Registry conditions: Infertility Treatment, Pregnancy Rates. Basic parameters: 18 years — 38 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Drug Clomiphene Citrate.
150 mg clomiphene citrate will be administered at third and seventh days of the menstrual cycle - Drug Pioglitazone (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.
Primary outcome measures
- Ovarian stimulation rate [Time frame: 10th day of menstrual cycle]
Secondary outcome measures (1)
- Pregnancy rates [Time frame: 5th day after end of menstrual cycle]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Pakistan Atomic Energy Commission Hospital — Islamabad
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. PMID 34404415
Identifiers
NCT: NCT07462065 · PGHI-IRB (DMe)-RCD-06-098