Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Poly Cystic Ovary Syndrome ( PCOS )

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

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

• 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: mostafa gomaa hamid halawa
• Collaborator: Ain Shams Maternity Hospital
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Hormones; Letrozole; Zuclomiphene

Criteria

Inclusion Criteria:

1. Age between 20-35

2. Primary or secondary infertility

3. Patients diagnosed as PCOs according to Rotterdam criteria (Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group.,2003)

Exclusion Criteria:

Any patients have any causes of infertility other than which mentioned in the inclusion criteria as:

1. Hyperprolactinemia.

2. 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

3. Thyroid dysfunction.

4. Diabetes Mellitus.

5. Known or suspicious tubal factor infertility by HSG or laparoscope.

6. Endometrioses or pelvic inflammatory diseases .