Dosage Optimization for Letrozole Treatment
1 other identifier
interventional
44
1 country
1
Brief Summary
In a prospective interventional study, 44 Clomiphene resistant infertile patients were selected from Abolfazl Infertility Clinic of Bushehr University of Medical Sciences. Letrozole was given orally in a dose of 2.5mg, 5mg and 7.5mg, respectively. If the patient displayed no response, the dosage was increased. The size of follicle, endometrial thickness, estradiol, complications and clinical pregnancy rate were evaluated as the final outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2008
Typical duration for phase_4
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
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 15, 2011
CompletedFirst Posted
Study publicly available on registry
March 16, 2011
CompletedMarch 28, 2011
January 1, 2008
2.9 years
March 15, 2011
March 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
normal follicular size
two years
Secondary Outcomes (1)
clinical and current pregnancy rates
two years
Interventions
Eligibility Criteria
You may qualify if:
- The study group consisted of polycystic ovarian syndrome(PCOS) patients diagnosed according to the Rotterdam criteria. The investigators defined Clomiphene citrate (Clomid, Iran hormone,Tehran,Iran) resistance as anovulation after consumption of 3 cycles of cc at 150 mg/day, determined by serial estradiol monitoring and sonography. Patients resistant to Clomiphene citrate became candidates for letrozole (Femara,Novartis,Quebec,Canada) consumption at the step-up of the protocol. Patients were between 18 and 39 years of age, body mass index (BMI) was \> 19 or \< 30 kg/m2 and day 3 follicle-stimulating hormone (FSH) \< 12Miu/Ml.
You may not qualify if:
- abnormal thyroid Function test
- hyperprolactinoma
- galactorrhea
- male-factor infertility
- tubal and uterine causes of infertility (hysterosalpingography)
- abnormal response in progesterone challenge test which implies no endogenous estrogen production
- poor patient compliance
- complications with treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bushehr university of medical science
Bushehr, Bushehr, 0098, Iran
Related Publications (1)
Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.
PMID: 36165742DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elham Rahmani, Dr
Bushehr University of Medical Science
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 15, 2011
First Posted
March 16, 2011
Study Start
January 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
March 28, 2011
Record last verified: 2008-01