Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome
Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome
2 other identifiers
interventional
250
1 country
1
Brief Summary
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 responding to treatment with Clomiphene alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
June 1, 2009
CompletedJune 1, 2009
May 1, 2009
2.6 years
May 28, 2009
May 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Principally the ovulation rate as well as the number of growing and mature follicles, serum E2 (pg/ml), serum P (ng/mL), and endometrial thickness (mm).
Secondary Outcomes (1)
The occurrence of pregnancy and miscarriage.
Study Arms (2)
Letrozole
EXPERIMENTALMetformin-CC
ACTIVE COMPARATORInterventions
2.5 mg letrozole daily from day 3 of the menses for 5 days
150 mg CC for 5 days starting from day 3 of menstruation
Eligibility Criteria
You may qualify if:
- CC resistant PCOS
You may not qualify if:
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University Hospitals,OB/GYN department
Al Mansurah, Dakahlia Governorate, 35511, Egypt
Related Publications (2)
Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.
PMID: 16595197BACKGROUNDSiebert TI, Kruger TF, Steyn DW, Nosarka S. Is the addition of metformin efficacious in the treatment of clomiphene citrate-resistant patients with polycystic ovary syndrome? A structured literature review. Fertil Steril. 2006 Nov;86(5):1432-7. doi: 10.1016/j.fertnstert.2006.06.014. Epub 2006 Sep 27.
PMID: 17007847BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hatem Abu Hashim, MD. MRCOG
Mansoura University Hospital
- STUDY DIRECTOR
Tarek Shokair, MD
Mansoura University Hospital
- STUDY CHAIR
Ahmed Badawy, MD.PhD.
Mansoura University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 28, 2009
First Posted
June 1, 2009
Study Start
June 1, 2006
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
June 1, 2009
Record last verified: 2009-05