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Follicular Flushing

Primary Purpose

Fertilization

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aspiration without flushing follicles with culture media
Follicular Flushing
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fertilization focused on measuring IVF stimulation., Poor responders., IVF patients with poor response to stimulation

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • New York Presbyterian Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Follicular flushing

Arm Description

Flushing follicles with embryo culture media prior to aspiration.

Outcomes

Primary Outcome Measures

FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
To evaluate the number of oocytes retrieved with follicular flushing in poor responders

Secondary Outcome Measures

FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
To evaluate: - # of embryos transferred
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Fertilization rates.
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Implantation rates
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Pregnancy rates
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Live birth rates
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Operating room anesthesia time.
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Luteal E2 level.
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Luteal P4 level.

Full Information

First Posted
February 16, 2012
Last Updated
January 10, 2019
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01558141
Brief Title
Follicular Flushing
Official Title
Follicular Flushing on Cycle Outcomes in Poor Responders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertilization
Keywords
IVF stimulation., Poor responders., IVF patients with poor response to stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Follicular flushing
Arm Type
Active Comparator
Arm Description
Flushing follicles with embryo culture media prior to aspiration.
Intervention Type
Other
Intervention Name(s)
Aspiration without flushing follicles with culture media
Intervention Description
Aspiration without flushing follicles with culture media.
Intervention Type
Other
Intervention Name(s)
Follicular Flushing
Intervention Description
Flushing follicles with embryo culture media prior to aspiration.
Primary Outcome Measure Information:
Title
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Description
To evaluate the number of oocytes retrieved with follicular flushing in poor responders
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Description
To evaluate: - # of embryos transferred
Time Frame
2 weeks
Title
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Description
Fertilization rates.
Time Frame
2 weeks
Title
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Description
Implantation rates
Time Frame
2 weeks
Title
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Description
Pregnancy rates
Time Frame
2 weeks
Title
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Description
Live birth rates
Time Frame
2 weeks
Title
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Description
Operating room anesthesia time.
Time Frame
2 weeks
Title
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Description
Luteal E2 level.
Time Frame
2 weeks
Title
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS
Description
Luteal P4 level.
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven D. Spandorfer, MD
Organizational Affiliation
Weill Medical College of Cornell
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24014603
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.
Results Reference
derived

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Follicular Flushing

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