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

NCT02551367 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2015-09-16

No results posted yet for this study

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

Conditions

  • Anovulation
  • Polycystic Ovary Syndrome

Interventions

DRUG

Letrozole

2.5 mg will taken from day 2 to day 6 of the cycle , for 3 consecutive cycles

DRUG

Clomiphene citrate

50 mg twice daily orally from day 2 to day 6 , for 3 consecutive cycles

DRUG

hcg hormone

10.000 iu im injection when follicle diameter reach 18 mm by transvaginal ultrasound

Sponsors & Collaborators

  • Ain Shams Maternity Hospital

    collaborator OTHER

  • mostafa gomaa hamid halawa

    lead OTHER

Principal Investigators

  • mohamed osama, md · ain-shams university , cairo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-05-31
Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02551367 on ClinicalTrials.gov