None listed
Conditions
Brief summary
The primary purpose of this study is to compare the efficacy of clomiphene citrate (an oral medication given to stimulate the ovaries, resulting in the release of more eggs) followed by intrauterine insemination (a procedure that places sperm directly into the uterus) at the expected time of ovulation versus Clomiphene citrate with timed vaginal intercourse ( i.e. natural intercourse around the expected time of ovulation) as the first-line treatment option to achieve pregnancy for subfertility due to absence of ovulation in cases of polycystic ovary syndrome (PCOS) which is a condition where the ovaries contain more small follicles (the sacs in which eggs develop) than normal. It affects menstruation, resulting in irregular periods or no periods at all, prevents ovulation and causes excessive body hair.
Interventions
Clomiphene citrate and intrauterine insemination.
Clomiphene citrate (Clomid tablets (registered trademark); Global Napi Pharmaceuticals, Cairo, Egypt) was administered orally for 5 days starting from day 3 of spontaneous or induced menstruation using a starting dose of 50 mg daily. If ovulation did not occur, the dose was increased by 50 mg in successive cycles until the ovulation was achieved or up to a maximal dose of 150 mg daily. Patients were monitored by transvaginal ultrasound for the me
Clomiphene citrate and intrauterine insemination. Clomiphene citrate (Clomid tablets (registered trademark); Global Napi Pharmaceuticals, Cairo, Egypt) was administered orally for 5 days starting from day 3 of spontaneous or induced menstruation using a starting dose of 50 mg daily. If ovulation did not occur, the dose was increased by 50 mg in successive cycles until the ovulation was achieved or up to a maximal dose of 150 mg daily. Patients were monitored by transvaginal ultrasound for the mean follicular diameter and endometrial thickness in the days 10, 12, and 14 of the cycle. human chorionic gonadotropin (hCG ) a total of 10,000 IU Intramuscular (IM) (Choriomon; Institut Biochimique SA (IBSA), Lugano, Switzerland) was given when one follicle measured at least 18 mm was found. Intrauterine insemination(IUI) was performed 32-36 hours after hCG injection. All couples underwent a maximum of three cycles of treatment. Semen preparation was done utilizing swim-up technique. 0.5 mL of the sperm suspension was introduced into the uterine cavity using a flexible intrauterine cannula (Gynetics Medical Products N.V. Harmont, Achel, Belgium). So both treatments including human chorionic gonadotropin (hCG) injection will be given at the same time with the following sequence; Clomiphene citrate followed by ultrasound scanning, then human chorionic gonadotropin (hCG) was given to trigger ovulation once evidence of mature follicle (18mm) appeared by ultrasound scanning. Lastly, intrauterine insemination(IUI) was done 32-36 hours after human chorionic gonadotropin (hCG) injection.
Sponsors
Hatem Abu Hashim
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
20 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
polycystic ovary syndrome No other infertility factors No previous use of ovarian stimulation drugs
Exclusion criteria
Congenital adrenal hyperplasia, Cushing syndrome, Androgen secreting tumors
Outcome results
None listed