- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02377479
Endocrinology Profile in Patients Undergoing Clomiphene, Letrozole, and Combination Clomiphene and Letrozole Cycles
Study Overview
Detailed Description
After the initial physician consultation and investigations have been completed, the treatment options will be reviewed with the patient. If the patient chooses ovulation induction with an oral medication, then she will be offered participation in the study.
If she chooses to participate, the patient will then undergo ovulation induction with either clomiphene, letrozole, or a combination of both medications. The patient will be randomized to the order that each medication regimen will be started. Prior to starting each treatment cycle, a serum beta-hCG (serum beta-hCG < 5IU/L) or urine pregnancy test will be performed to rule out pregnancy.
During one treatment cycle, the patient will take 100mg clomiphene orally from cycle days 3-7. This dose is routinely used for ovulation induction in the investigators clinic. Blood work including an estradiol (E2), FSH, inhibin B and LH will be obtained on cycle days 3, 7, and 9. As these lab tests are routinely performed in the investigators REI laboratory, there will be no additional cost to the patient. A baseline follicle count by ultrasound during each treatment cycle will be measured on cycle day 3, and then again on cycle day 12, 13, or 14, depending on the cycle length until the lead follicle is 18mm or greater. Once at least one follicle has reached this mature size, an Ovidrel trigger (250 mcg hCG subcutaneously) will be administered to initiate ovulation. The patient will have an intrauterine insemination (IUI) 36 hours after Ovidrel injection. These procedures are the current standard of care in the investigators fertility center for patients with unexplained infertility.
Ovulation during each treatment cycle will also be confirmed with a serum progesterone measurement >3 nmol/L on cycle day 20-25. This blood test is not always performed, but is a common way to assess ovulation.
If the patient ovulated, a pregnancy test will be performed approximately 2 weeks later. If pregnancy has not occurred, the next medication would be attempted after the patient has a period.
During the second treatment cycle, the patient will take 5mg Letrozole orally from cycle days 3-7. The remainder of the prior protocol for the clomiphene cycle would then be performed. This medication dose and protocol are also the current standard of care in the investigators fertility center.
During the third treatment cycle, the patient will take a dose of 5mg Letrozole every night and 100mg clomiphene every day after lunch from cycle days 3-7. The remainder of the prior protocol for the clomiphene cycle would then be performed. This combination dose would be the experimental portion of the protocol, as it has been done before, but is not currently standard of care in the investigators fertility center.
If the patient does not ovulate despite giving hCG subcutaneously or the lead follicle never reaches >/= 18mm, that treatment cycle will be abandoned. After the patients next period, she will be started immediately on the next treatment cycle.
If, upon failing to ovulate with any of the medication regimens, a subject declines to continue with the next medication and would prefer to go straight to gonadotropin treatment with or without IVF treatment, the subject will still remain as part of the study and only the US and bloodwork values obtained while still involved in the study will be included.
A subject will have completed the study after one cycle of clomiphene, one cycle of letrozole, and one cycle of combination clomiphene/IUI have been achieved. For patients that do not achieve a pregnancy at the end of the study, they will have the option to undergo other fertility treatments that will be discussed with their primary fertility specialist.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Beachwood, Ohio, United States, 44122
- University Hospitals Fertility Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 1 month without any fertility medication
Exclusion Criteria:
- Patients unable to consent for the study
- Patients with polycystic ovarian syndrome or anovulatory women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Clomiphene alone
The patient will take 100mg clomiphene orally from cycle days 3-7
|
Taken for controlled ovarian hyperstimulation.
Other Names:
|
Active Comparator: Letrozole alone
The patient will take 5mg Letrozole orally from cycle days 3-7
|
Taken for controlled ovarian hyperstimulation
Other Names:
|
Experimental: Combination Clomiphene and Letrozole
The patient will take a dose of 5mg Letrozole every night and 100mg clomiphene every day after lunch from cycle days 3-7.
|
Taken for controlled ovarian hyperstimulation.
Other Names:
Taken for controlled ovarian hyperstimulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The endocrinology profile (LH, FSH, estradiol, inhibin B) during a letrozole, clomiphene, and combination letrozole and clomiphene cycle
Time Frame: 1 month
|
The LH, FSH, estradiol, inhibin B levels will be measured on cycle days 3, 7, and 9.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1. Pregnancy rate
Time Frame: 1 month
|
1 month
|
Ovulation rate
Time Frame: 1 month
|
1 month
|
Ongoing pregnancy rate (pregnancy with fetal heartbeat > 12 weeks gestational age)
Time Frame: 12 weeks
|
12 weeks
|
Miscarriage rate
Time Frame: 10 weeks
|
10 weeks
|
Multiple pregnancy rate (twins and higher order multiples)
Time Frame: 6- 8 weeks
|
6- 8 weeks
|
Number of mature follicles (>/= 18mm)
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infertility
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Letrozole
- Clomiphene
Other Study ID Numbers
- 043234
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
King's College LondonNot yet recruitingInfertility | Infertility, Female | Infertility Unexplained | Infertility of Tubal Origin
-
Gazi UniversityCompletedMale Infertility | Unexplained Infertility
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMale Infertility, AzoospermiaUnited States
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Istanbul University - Cerrahpasa (IUC)RecruitingInfertility | Sexual Dysfunction | Infertility, Male | Nurse's Role | Sexuality | Infertility; FemaleTurkey
Clinical Trials on Clomiphene
-
Weill Medical College of Cornell UniversityWithdrawn
-
University Magna GraeciaCompletedPolycystic Ovary Syndrome | AnovulationItaly
-
Dinesh Khanna, MD, MSBayerCompletedScleroderma | Digital UlcersUnited States
-
Xiyuan Hospital of China Academy of Chinese Medical...Dongzhimen Hospital, Beijing; Beijing Hospital of Traditional Chinese Medicine and other collaboratorsUnknownPolycystic Ovarian Syndrome | Hyperprolactinemia | Anovulatory Infertility | Abnormal Uterine Bleeding-Ovulatory Disorders | Luteinized Unruptured Follicle Syndrome | Corpus Luteum Insufficiency | Ovarian Insufficiency
-
Bagcilar Training and Research HospitalCompletedUnexplained Infertility | Ovulation DisorderTurkey
-
Universitair Ziekenhuis BrusselCompleted
-
Kufa UniversityCompletedPolycystic Ovary SyndromeIraq
-
Milton S. Hershey Medical CenterMayo ClinicCompleted
-
Weill Medical College of Cornell UniversityRecruitingTestosterone DeficiencyUnited States