Clinical Trial: Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Poly Cystic Ovary Syndrome ( PCOS )
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
Brief Summary:
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
Detailed Summary:
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:
Sponsor: mostafa gomaa hamid halawa
Current Primary Outcome: ovulation rate [ Time Frame: up to 24 weeks. ]
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 hCGwill 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.
- Ovulation rate is assessed by number of mature follicle (diameter 18-22 mm) per cycle .
Original Primary Outcome: Same as current
Current Secondary Outcome:
- day 21 progesterone level [ Time Frame: up to 24 weeks ]day 21 serum progesterone level 10 ng/ml is ovulatory
- Endomertial thickness [ Time Frame: up to 24 weeks ]Endometrial thickness of 8 mm considered a satisfactory response of the endometrium.
- On gowing pregnancy [ Time Frame: up to 24 weeks ]pregnancy when diagnosed by ultrasound .
- Chemical pregnancy [ Time Frame: up to 24 weeks ]pregnancy when diagnosed by serum positive hcg test .
Original Secondary Outcome: Same as current
Information By: Ain Shams Maternity Hospital
Dates:
Date Received: September 5, 2015
Date Started: October 2015
Date Completion: July 2016
Last Updated: September 15, 2015
Last Verified: September 2015