The aim of this study is to compare the efficacy of letrozole on ovulation induction to that of clomiphene citrate in women suffering polycystic ovary syndrome.~Research question:~In women with PCOS , dose letrozole effective in ovulation induction as clomiphene citrate?~Researcher hypothesis:~In women with pcos , letrozole may be as effective as clomiphene citrate in ovulation induction.~Patients and methods Site: this study will be recruited from women attending infertility outpatient clinic at Ain Shams university maternity hospital.~Design: Randomized controlled trial.~Study population: 110 infertile women diagnosed as polycystic ovary syndrome (PCOS) at the age group of 20-35 distributed randomly:~55 women will receive letrozole 2.5mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles.~55 women will receive clomiphene citrate 50 mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles.~Inclusion criteria:~Age between 20-35~Primary or secondary infertility~Patients diagnosed as PCOS according to Rotterdam criteria :~Menstrual irregularities:~oligomenorrhea and/or anovulation.~Oligomenorrhea (menses that occur at intervals greater than 35 days)~Excess androgen activity. - Clinically: hirsutism .~Biochemically: elevated serum androgen. polycystic ovaries (by gynecologic ultrasound)~Exclusion criteria:~Any patients have any causes of infertility other than which mentioned in the inclusion criteria as:~Hyperprolactinemia.~Male factor of infertility.~WHO Guidelines 2010 for Normal seminal fluid analysis :~- Volume> 1.5 ml~- ph 7.2 to 8.0~Liquefaction time 20 to 30 min~Sperms concentration >15 million/ml~Total motility 40%(Progressive motility + non progressive motility)~Progressive motility 32%~Morphology > 4% normal forms~Thyroid dysfunction.~Diabetes Mellitus.~Known or suspicious tubal factor infertility ( by hysteroslapingograrhy (HSG) or laparoscope.~Endometrioses or pelvic inflammatory diseases .~Patients will be subjected to:~Complete history taking:~Details a bout name, age~Menstrual history with determination of menarche~Amenorrhea or oligomenorrhea , Regularity of the cycle~History of endocrine disease.~History of previous operations.~Physical examination:~General examination:~With special concern to:~--Acne.~--Hirsutism .~Weight.~Height~BMI was determined :~Wt. in kg ـــــــــــــــــــ =~) Height in m)2~Abdominal examination:~for scar of previous pelvic or abdominal operations .~Pelvic examination:~vaginal examination for enlarged cystic ovaries.~ultrasound for diagnosis of pcos.~The patients will randomly assigned to receive either letrozole (2.5 mg twice daily ) or clomiphene citrate (50 mg twice daily ) from day 2 to day 6 of menstrual cycle .~Follicular monitoring will be done by transvaginal ultrasonography (TVS) on alternate days from day 9 of menstrual cycle until a mature follicle detected. Follicle considered mature when it attained 18 mm in size or more by averaging inner two diameters of the follicle.~A single injection of 10,000 IU human chorionic gonadotrophin (hCG) will be given, if at least one follicle attained 18 mm. TVS will be done after 48 h of hCG injection to determine follicle rupture. If the follicle found unruptured, TVS repeated after 72 h of the hCG injection to detect whether follicle has ruptured or not. Ovulation ascertained by observing rupture of the follicle by ultrasonogram (USG).~Endometrial thickness of 8 mm considered a satisfactory response of the endometrium.~on day 21 serum progesterone level will measured. A progesterone level of 10 ng/ml considered as ovulatory.~PARAMETERS~Primary outcome measure :~(1) Rate of ovulation assessed by number of mature follicles produced per cycle .~Secondary outcome measures :~(2) Serum progesterone level on day 21 ( assessed up to 24 weeks). (3) Mean endometrial thickness ( assessed up to 24 weeks). (4) Chemical pregnancy ( assessed up to 24 weeks). (5) Ongoing pregnancy ( assessed up to 24 weeks).
110 infertile women diagnosed as polycystic ovary syndrome (PCOS) at the age group of 20-35 distributed randomly :~55 women will receive letrozole 2.5mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles.~55 women will receive clomiphene citrate 50 mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles.~Patients will be subjected to:~Complete history taking:~Details about name, age~Menstrual history with determination of menarche~Amenorrhea or oligomenorrhea , Regularity of the cycle~History of endocrine disease.~History of previous operations.~Physical examination:~General examination:~With special concern to:~--Acne.~--Hirsutism .~--Weight.~--Height~--BMI was determined :~Wt. in kg ـــــــــــــــــــ =~) Height in m)2~- Abdominal examination :~for scar of previous pelvic or abdominal operations .~Pelvic examination :~vaginal examination for enlarged cystic ovaries.~ultrasound for diagnosis of pcos.~PARAMETERS:~(1) rate of ovulation (primary parameter). (2) serum progesterone level on day 21. (3) number of mature follicles produced per cycle. (4) mean endometrial thickness. (6) chemical pregnancy. (7) ongoing pregnancy