Follicular Flushing

Follicular Flushing on Cycle Outcomes in Poor Responders

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.

Study Overview

• Status: Completed
• Conditions: Fertilization
• Intervention / Treatment: Other: Aspiration without flushing follicles with culture media; Other: Follicular Flushing

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	To evaluate the number of oocytes retrieved with follicular flushing in poor responders	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	To evaluate: - # of embryos transferred	2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Fertilization rates.	2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Implantation rates	2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Pregnancy rates	2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Live birth rates	2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Operating room anesthesia time.	2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Luteal E2 level.	2 weeks
FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Luteal P4 level.	2 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Steven D. Spandorfer, MD, Weill Medical College of Cornell

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: March 19, 2012
• First Posted (Estimate): March 20, 2012

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: IVF stimulation.; Poor responders.; IVF patients with poor response to stimulation
• Additional Relevant MeSH Terms: Skin Manifestations; Flushing
• Other Study ID Numbers: 1108011882