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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follicular flushing | Active Comparator | Flushing follicles with embryo culture media prior to aspiration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspiration without flushing follicles with culture media | Other | Aspiration without flushing follicles with culture media. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS | To evaluate the number of oocytes retrieved with follicular flushing in poor responders | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS | To evaluate: - # of embryos transferred | 2 weeks |
| FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS | Fertilization rates. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven D. Spandorfer, MD | Weill Medical College of Cornell | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24014603 | Derived | 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. |
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| ID | Term |
|---|---|
| D003470 | Culture Media |
| ID | Term |
|---|---|
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D004864 | Equipment and Supplies |
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| Follicular Flushing | Other | Flushing follicles with embryo culture media prior to aspiration. |
|
| 2 weeks |
| FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS | Implantation rates | 2 weeks |
| FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS | Pregnancy rates | 2 weeks |
| FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS | Live birth rates | 2 weeks |
| FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS | Operating room anesthesia time. | 2 weeks |
| FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS | Luteal E2 level. | 2 weeks |
| FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS | Luteal P4 level. | 2 weeks |