Follicular Flushing
Condition: Fertilization
MeSH terms: Flushing
Study type: Interventional

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.
    

Intervention name(s): Aspiration without flushing follicles with culture media; Follicular Flushing
Intervention type(s): Other; Other
Intervention description(s): Aspiration without flushing follicles with culture media.; Flushing follicles with embryo culture media prior to aspiration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF stimulation.; Poor responders.; IVF patients with poor response to stimulation