Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-09-30
2013-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Follicular flushing
Flushing follicles with embryo culture media prior to aspiration.
Aspiration without flushing follicles with culture media
Aspiration without flushing follicles with culture media.
Follicular Flushing
Flushing follicles with embryo culture media prior to aspiration.
Interventions
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Aspiration without flushing follicles with culture media
Aspiration without flushing follicles with culture media.
Follicular Flushing
Flushing follicles with embryo culture media prior to aspiration.
Eligibility Criteria
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Inclusion Criteria
* Pts with ≤ 4 follicles that are ≥ 12mm on day of HCG
Exclusion Criteria
18 Years
45 Years
FEMALE
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Steven D. Spandorfer, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell
Locations
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New York Presbyterian Hospital
New York, New York, United States
Countries
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References
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Mok-Lin E, Brauer AA, Schattman G, Zaninovic N, Rosenwaks Z, Spandorfer S. Follicular flushing and in vitro fertilization outcomes in the poorest responders: a randomized controlled trial. Hum Reprod. 2013 Nov;28(11):2990-5. doi: 10.1093/humrep/det350. Epub 2013 Sep 5.
Other Identifiers
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1108011882
Identifier Type: -
Identifier Source: org_study_id
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