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Endocrinology Profile in Patients Undergoing Clomiphene, Letrozole, and Combination Clomiphene and Letrozole Cycles
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The goal of the study is to measure serial hormonal levels in patients undergoing clomiphene, letrozole, and a combination clomiphene and letrozole cycle. This information may help us to optimize less expensive medications for ovulation induction, reduce the number of treatment cycles to achieve a successful pregnancy, and use a medication regimen that may result in fewer multiple gestation pregnancies.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedMay 12, 2022
May 1, 2022
2 years
February 25, 2015
May 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The endocrinology profile (LH, FSH, estradiol, inhibin B) during a letrozole, clomiphene, and combination letrozole and clomiphene cycle
The LH, FSH, estradiol, inhibin B levels will be measured on cycle days 3, 7, and 9.
1 month
Secondary Outcomes (6)
1. Pregnancy rate
1 month
Ovulation rate
1 month
Ongoing pregnancy rate (pregnancy with fetal heartbeat > 12 weeks gestational age)
12 weeks
Miscarriage rate
10 weeks
Multiple pregnancy rate (twins and higher order multiples)
6- 8 weeks
- +1 more secondary outcomes
Study Arms (3)
Clomiphene alone
ACTIVE COMPARATORThe patient will take 100mg clomiphene orally from cycle days 3-7
Letrozole alone
ACTIVE COMPARATORThe patient will take 5mg Letrozole orally from cycle days 3-7
Combination Clomiphene and Letrozole
EXPERIMENTALThe patient will take a dose of 5mg Letrozole every night and 100mg clomiphene every day after lunch from cycle days 3-7.
Interventions
Taken for controlled ovarian hyperstimulation.
Taken for controlled ovarian hyperstimulation
Eligibility Criteria
You may qualify if:
- Age 18-40 years old
- Body mass index (BMI) \> 18 kg/m\^2 and \< 40kg/m\^2
- No contraindications to clomiphene or letrozole
- Ovulatory women
- month without any fertility medication
You may not qualify if:
- Patients unable to consent for the study
- Patients with polycystic ovarian syndrome or anovulatory women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Fertility Center
Beachwood, Ohio, 44122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 3, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2017
Last Updated
May 12, 2022
Record last verified: 2022-05