Effect Clomiphene vs Clomiphene Along With Pioglitazone on Ovarian Stimulation Rate

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Clomiphene Citrate.
  150 mg clomiphene citrate will be administered at third and seventh days of the menstrual cycle
• Препарат 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.

Первичные конечные точки

• Ovarian stimulation rate [Срок оценки: 10th day of menstrual cycle]

Вторичные конечные точки (1)

• Pregnancy rates [Срок оценки: 5th day after end of menstrual cycle]

Критерии участия

Критерии включения

Normal hysterosalpingography Normal spermogram Suffering from PCOS Ovarian cysts less than 20mm.

Критерии исключения

History of chronic cardiovascular disease Chronic kidney disease Diabetes Thyroid disease Pulmonary disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Pakistan Atomic Energy Commission Hospital — Islamabad

Публикации

• 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

Идентификаторы

NCT: NCT07462065 · PGHI-IRB (DMe)-RCD-06-098

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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