Comparison Between Letrozole and Laparoscopic Ovarian Drilling in Women With Clomiphene Resistant Polycystic Ovarian Syndrome (PCOS)
1 other identifier
interventional
140
1 country
2
Brief Summary
140 women with clomiphene resistant PCOS will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Letrozole, group 2 will have laparoscopic ovarian drilling (LOD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
2 active sites
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
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 26, 2014
CompletedFirst Posted
Study publicly available on registry
December 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedJuly 29, 2016
July 1, 2016
2.5 years
November 26, 2014
July 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Ovulation
Regular vaginal ultrasounds will be done at regular intervals starting from the 10th day after the intervention
6 weeks after starting the intervention
Secondary Outcomes (1)
Pregnancy
6 months after starting the intervention
Study Arms (2)
Letrozole
ACTIVE COMPARATOR70 women will receive Letrozole (Femara®, Novartis, Switzerland) 2.5mg twice daily for 5 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding
Ovarian drilling
ACTIVE COMPARATOR70 women will have LOD in which the ovaries will be stabilised by grasping the ovarian ligament and monopolar diathermy will be used to do 4-10 punctures in each ovary. The number of punctures will be individualised according to the size of the ovary.
Interventions
Eligibility Criteria
You may qualify if:
- Clomiphene resistant PCOS women
You may not qualify if:
- Other causes of infertility.
- Hyperprolactinaemia.
- BMI\>35.
- Previous Letrozole or LOD therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (2)
BeniSuef University hospitals
BeniSuef, Egypt
Cairo University Hospitals
Cairo, Egypt
Related Publications (2)
Vendola K, Zhou J, Wang J, Famuyiwa OA, Bievre M, Bondy CA. Androgens promote oocyte insulin-like growth factor I expression and initiation of follicle development in the primate ovary. Biol Reprod. 1999 Aug;61(2):353-7. doi: 10.1095/biolreprod61.2.353.
PMID: 10411511BACKGROUNDvan Wely M, Bayram N, van der Veen F, Bossuyt PM. Predictors for treatment failure after laparoscopic electrocautery of the ovaries in women with clomiphene citrate resistant polycystic ovary syndrome. Hum Reprod. 2005 Apr;20(4):900-5. doi: 10.1093/humrep/deh712. Epub 2005 Jan 7.
PMID: 15640254BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Gynecology and Obstetrics
Study Record Dates
First Submitted
November 26, 2014
First Posted
December 3, 2014
Study Start
November 1, 2014
Primary Completion
May 1, 2017
Last Updated
July 29, 2016
Record last verified: 2016-07