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:

1. Details about name, age
2. Menstrual history with determination of menarche
3. Amenorrhea or oligomenorrhea , Regularity of the cycle
4. History of endocrine disease.

5. 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:

   1. Age between 20-35
   2. Primary or secondary infertility
   3. 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