Study to Compare Between Combimed Metformin-letrozole and Ovarian Drilling in Pcos With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome

Focus of Study Clinical Trial

Official title:

Phase 1 Study of Efficacy of Combined Metformin-letrozole in Comparison With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693289
• Other study ID #: elsharkwy t
• Status: Completed
• Phase: Phase 1
• First received: September 23, 2012
• Last updated: September 25, 2012
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the study compare the hormonal-metabolic and reproductive outcome between combined metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic syndrome

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• polycystic ovary syndrome

• infertility

• clomiphene citrate resistance

Exclusion Criteria:

• women with other causes of infertility as male factor or tubal factor, those with endocrine disorders as thyroid dysfunction and hyperprolactinemia women who received hormonal treatment or ovulation induction drugs 3 months prior to the study

• pregnancy during follow up

Related Conditions & MeSH terms

• Focus of Study
• Polycystic Ovary Syndrome

Intervention

Drug:
• metformin plus letrozole

Procedure:
• ovarian drilling

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hormonal and metabolic changes		6 months
Secondary	reproductive outcome		6months