Follicular Flushing

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01558141
First received: February 16, 2012
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Fertilization.
Other: Aspiration without flushing follicles with culture media
Other: Follicular Flushing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Follicular Flushing on Cycle Outcomes in Poor Responders

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    To evaluate the number of oocytes retrieved with follicular flushing in poor responders


Secondary Outcome Measures:
  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    To evaluate:

    - # of embryos transferred


  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Fertilization rates.

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Implantation rates

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Pregnancy rates

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Live birth rates

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Operating room anesthesia time.

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Luteal E2 level.

  • FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Luteal P4 level.


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Follicular flushing
Flushing follicles with embryo culture media prior to aspiration.
Other: Aspiration without flushing follicles with culture media
Aspiration without flushing follicles with culture media.
Other: Follicular Flushing
Flushing follicles with embryo culture media prior to aspiration.

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558141

Locations
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Steven D. Spandorfer, MD Weill Medical College of Cornell
  More Information

No publications provided by Weill Medical College of Cornell University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01558141     History of Changes
Other Study ID Numbers: 1108011882
Study First Received: February 16, 2012
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
IVF stimulation.
Poor responders.
IVF patients with poor response to stimulation

ClinicalTrials.gov processed this record on October 19, 2014