Clinical trial NCT01558141: Follicular Flushing
Official title: Follicular Flushing on Cycle Outcomes in Poor Responders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertilization
Keywords: IVF stimulation.
Poor responders.
IVF patients with poor response to stimulation
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
timeFrame: 2 weeks
Secondary outcomes:
measure: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
timeFrame: 2 weeks
measure: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
timeFrame: 2 weeks
measure: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
timeFrame: 2 weeks
measure: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
timeFrame: 2 weeks
measure: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
timeFrame: 2 weeks
measure: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
timeFrame: 2 weeks
measure: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
timeFrame: 2 weeks
measure: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Weill Medical College of Cornell
name: Steven D. Spandorfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.