Follicular Flushing
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Women's Studies |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/16/2019 |
| Start Date: | September 2011 |
| End Date: | May 2013 |
Follicular Flushing on Cycle Outcomes in Poor Responders
Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy,
which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm
insemination, embryo culture and embryo transfer.
The oocytes are removed during surgery by aspirating the follicles using a single lumen
needle with an ultrasound to guide the procedure. There is some data that flushing the
follicles with embryo culture media before aspiration using a double lumen needle increases
the number of oocytes retrieved, particularly among poor responding patients for whom each
additional oocyte recovered may substantially alter the outcome of that IVF cycle.
The objective of the research is to evaluate the effect of follicular flushing in poor
responders on IVF cycle outcomes.
which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm
insemination, embryo culture and embryo transfer.
The oocytes are removed during surgery by aspirating the follicles using a single lumen
needle with an ultrasound to guide the procedure. There is some data that flushing the
follicles with embryo culture media before aspiration using a double lumen needle increases
the number of oocytes retrieved, particularly among poor responding patients for whom each
additional oocyte recovered may substantially alter the outcome of that IVF cycle.
The objective of the research is to evaluate the effect of follicular flushing in poor
responders on IVF cycle outcomes.
Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy,
which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm
insemination, embryo culture and embryo transfer. The number of embryos obtained is dependent
on the number of oocytes retrieved.
The objective of the research is to evaluate the effect of follicular flushing in poor
responders on IVF cycle outcomes, including the number of oocytes retrieved, number of mature
oocytes, fertilization rate, number of embryos transferred, implantation rate, miscarriage
rate, live birth rate, operating room time, and luteal estradiol and progesterone levels.
The research entails a prospective, randomized, controlled trial of poor-responder patients
who are undergoing IVF treatment at The Ronald O. Perelman and Claudia Cohen Center for
Reproductive Medicine, defined as patients who have ≤ 4 follicles that are ≥ 12mm on the day
of hCG trigger.
Patients identified as poor responders will be consented and randomized to follicular
flushing versus aspiration without flushing. A 2-5mL flush using embryo culture media
followed by aspiration of the follicle will be performed in the patients randomized to the
flushing group, with subsequent flushes until an oocyte is identified or up to 4 flushes
maximum.
Patients being enrolled in this research study will undergo IVF regardless of participation
in this research study.
Randomization:
A series of randomized blocks of 2 will be generated for the study. This will provide
assurance that after two patients are enrolled, there will be one patient assigned to each
group- follicular flushing versus aspiration without flushing. This process of blocked
randomization ensures an equal distribution between the two study arms of patients.
which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm
insemination, embryo culture and embryo transfer. The number of embryos obtained is dependent
on the number of oocytes retrieved.
The objective of the research is to evaluate the effect of follicular flushing in poor
responders on IVF cycle outcomes, including the number of oocytes retrieved, number of mature
oocytes, fertilization rate, number of embryos transferred, implantation rate, miscarriage
rate, live birth rate, operating room time, and luteal estradiol and progesterone levels.
The research entails a prospective, randomized, controlled trial of poor-responder patients
who are undergoing IVF treatment at The Ronald O. Perelman and Claudia Cohen Center for
Reproductive Medicine, defined as patients who have ≤ 4 follicles that are ≥ 12mm on the day
of hCG trigger.
Patients identified as poor responders will be consented and randomized to follicular
flushing versus aspiration without flushing. A 2-5mL flush using embryo culture media
followed by aspiration of the follicle will be performed in the patients randomized to the
flushing group, with subsequent flushes until an oocyte is identified or up to 4 flushes
maximum.
Patients being enrolled in this research study will undergo IVF regardless of participation
in this research study.
Randomization:
A series of randomized blocks of 2 will be generated for the study. This will provide
assurance that after two patients are enrolled, there will be one patient assigned to each
group- follicular flushing versus aspiration without flushing. This process of blocked
randomization ensures an equal distribution between the two study arms of patients.
Inclusion Criteria:
- Pts ages 18-45 undergoing IVF
- Pts with ≤ 4 follicles that are ≥ 12mm on day of HCG
Exclusion Criteria:
- Pts undergoing natural cycles (i.e. those with intentionally low # of follicles)
We found this trial at
1
site
Click here to add this to my saved trials
