Follicular Flushing

Fertilization Clinical Trial

Official title:

Follicular Flushing on Cycle Outcomes in Poor Responders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558141
• Other study ID #: 1108011882
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2015
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fertilization
• Flushing

Intervention

Other:
• Aspiration without flushing follicles with culture media
Aspiration without flushing follicles with culture media.
• Follicular Flushing
Flushing follicles with embryo culture media prior to aspiration.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	To evaluate the number of oocytes retrieved with follicular flushing in poor responders	2 weeks
Secondary	FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	To evaluate: - # of embryos transferred	2 weeks
Secondary	FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Fertilization rates.	2 weeks
Secondary	FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Implantation rates	2 weeks
Secondary	FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Pregnancy rates	2 weeks
Secondary	FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Live birth rates	2 weeks
Secondary	FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Operating room anesthesia time.	2 weeks
Secondary	FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Luteal E2 level.	2 weeks
Secondary	FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS	Luteal P4 level.	2 weeks