Clinical Trial: Follicular Flushing

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Follicular Flushing on Cycle Outcomes in Poor Responders

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 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 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-
Sponsor: Weill Medical College of Cornell University

Current Primary Outcome: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ]

To evaluate the number of oocytes retrieved with follicular flushing in poor responders


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ]

    To evaluate:

    - # of embryos transferred

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ]
    Fertilization rates.
  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ]
    Implantation rates
  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ]
    Pregnancy rates
  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ]
    Live birth rates
  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ]
    Operating room anesthesia time.
  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ]
    Luteal E2 level.
  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ]
    Luteal P4 level.


Original Secondary Outcome: Same as current

Information By: Weill Medical College of Cornell University

Dates:
Date Received: February 16, 2012
Date Started: September 2011
Date Completion:
Last Updated: June 10, 2015
Last Verified: June 2015