Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02377479 |
| Other study ID # |
043234 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2015 |
Study information
| Verified date |
May 2022 |
| Source |
University Hospitals Cleveland Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
