Clomiphene Citrate Plus uFSH Versus Aromatase Inhibitor Plus uFSH in Clomiphene Resistant Infertile PCOS Women
Clomiphene Citrate Plus HPuFSH Versus Letrozole Plus HPuFSH in Clomid Resistant Infertile PCOS Women
1 other identifier
interventional
160
1 country
1
Brief Summary
Polycystic ovarian syndrome (PCOS) is a condition characterized by infertility, infrequent periods and amenorrhea or irregular bleeding plus anovulatory infertility. Clomid is the standard first drug of treatment for ovulation induction. Ovulation and conception will occur in approximately 75 and 30 percent of cases respectively. Cases not ovulating in response to doses of clomid up to 150 mg/day are known as clomid resistant PCOS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
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
First Submitted
Initial submission to the registry
February 10, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMarch 6, 2013
March 1, 2013
1.3 years
February 10, 2013
March 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ovulation rate
percentage of ovulatory cycles per started and per completed cycles
30 days
Secondary Outcomes (2)
endometrial thickness
4 weeks
ongoing cycle pregnancy rate
16 weeks
Study Arms (2)
CC-plus uFSH
ACTIVE COMPARATORclomiphene citrate 50 mg tablets twice/day for cycle days 3-7 plus daily IM injection of 37.5 IU HP uFSH for days 3-12
Aromataze inhibitor plus uFSH
EXPERIMENTALAromataze inhibitor (litrezole )2.5 mg twice daily for cycle days 3-7 plus daily IM injection of uFSH 37.5 IU for cycle days 3-12
Interventions
literozole tablets 5 mg /day for days 3-7 plus intramuscular injections of uFSH 37.5 IU/day for days 3-12
clomiphene citrate 50 mg tablets twice /day for 5 days plus 37.5 IU uFSH IM injections daily for 10 days
Eligibility Criteria
You may qualify if:
- CC resistant PCOS
- Infertile
- Females
- Age 18-38
You may not qualify if:
- Hyperprolactinaemia
- Cushing syndrome
- Adult onset adrenal hyperplasia
- Age \> 38
- Other infertility factors in the couple than PCOS: male factor,tubal factor,edometriosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura Integrated fertility center
Al Mansurah, Dekahlia, Egypt
Related Publications (2)
Abdellah MS. Reproductive outcome after letrozole versus laparoscopic ovarian drilling for clomiphene-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2011 Jun;113(3):218-21. doi: 10.1016/j.ijgo.2010.11.026. Epub 2011 Apr 1.
PMID: 21457973BACKGROUNDPalomba S, Falbo A, Zullo F. Management strategies for ovulation induction in women with polycystic ovary syndrome and known clomifene citrate resistance. Curr Opin Obstet Gynecol. 2009 Dec;21(6):465-73. doi: 10.1097/GCO.0b013e328332d188.
PMID: 19809318BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
February 10, 2013
First Posted
February 15, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2014
Study Completion
September 1, 2014
Last Updated
March 6, 2013
Record last verified: 2013-03