Letrozole or Combined Clomiphene Citrate Metformin as a First Line Treatment in Women With Polycystic Ovarian Syndrome (PCO)

This study has been completed.
Information provided by (Responsible Party):
ahmed ali, Assiut University
ClinicalTrials.gov Identifier:
First received: August 31, 2012
Last updated: September 6, 2012
Last verified: September 2012
The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not treated before with any ovulation induction agent

Condition Intervention
Polycystic Ovary Syndrome
Drug: Letrozole
Drug: Clomiphene
Drug: Metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Letrozole Versus Clomiphene Citrate Plus Metformin in the First Treatment of Infertility in Patients With Polycystic Ovarian Syndrome

Resource links provided by NLM:

Further study details as provided by Assiut University:

Primary Outcome Measures:
  • ovulation rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Principally the ovulation rate as well as the number of growing and mature follicles and endometrial thickness (mm).

Secondary Outcome Measures:
  • The occurrence of pregnancy and miscarriage [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The occurrence of pregnancy and miscarriage

Enrollment: 200
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: letrozole
Letrozole tablets (Femara; Novartis Pharma, Switzerland) 2.5 mg letrozole daily from day 3 of the menses for 5 days
Drug: Letrozole
•Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland) 2.5 mg letrozole daily from day 3 of the menses for 5 days
Other Name: Femara; Novartis Pharma, Switzerland
Active Comparator: Metformin and clomiphene

.Drug: metformin (Cidophage®; CID,Cairo, Egypt) metformin 1500 daily for 3 months

  • Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) 100 mg CC for 5 days starting from day 3 of menstruation
Drug: Clomiphene
•Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) 100 mg CC for 5 days starting from day 3 of menstruation
Other Name: clomid
Drug: Metformin
•Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt) metformin HCl 1500 daily for 3 months
Other Name: Cidophage

  Show Detailed Description


Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All participants met the Rotterdam consensus criteria for the diagnosis of PCOS . .Primary infertility because of anovulation for at least 1 year.
  • Only fresh (not treated previously) cases were recruited. .The male partner of each participant was required to have a normal result on semen analysis (count>20million/ml,motility>40%and normal morphology >30%).
  • Each woman was required to have patent tubes on hysterosalpingography or on a diagnostic laparoscopy.

Exclusion Criteria:

  • Age below 18 years or above 35 years , trial of ovulation induction prior to the stud ,BMI >35 .
  • Presence of other causes of infertility; hyperprolactinemia (morning plasma prolactin concentration 30 ng/mL or more); any other endocrine, hepatic, or renal disorder; presence of an organic pelvic mass;
  • History of abdominal surgery that might have caused pelvic factor infertility.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01679574

Assiut University
Assiut, Egypt, 11111
Sponsors and Collaborators
Assiut University
Study Chair: Tarek al Hussaini, prof assiut university hospital
Study Director: Safowt Abd El Rady, Prof Assiut university hosiptal
Study Director: Mohamad S Abd Allah, Ass prof assiut university hosital
  More Information

Responsible Party: ahmed ali, Prinicple investigator, Assiut University
ClinicalTrials.gov Identifier: NCT01679574     History of Changes
Other Study ID Numbers: pcolcm 
Study First Received: August 31, 2012
Last Updated: September 6, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Assiut University:

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 22, 2016