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OpenTrials
Completed

NCT Number: NCT01558141

Follicular Flushing

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Hospital

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aspiration without flushing follicles with culture media

Other

Aspiration without flushing follicles with culture media.

follicular flushing

Other

Flushing follicles with embryo culture media prior to aspiration.

Primary outcomes

  1. 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

Secondary outcomes

  1. FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    Time frame: 2 weeks

    To evaluate:

    • # of embryos transferred
  2. FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    Time frame: 2 weeks

    Fertilization rates.

  3. FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    Time frame: 2 weeks

    Implantation rates

  4. FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    Time frame: 2 weeks

    Pregnancy rates

  5. FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    Time frame: 2 weeks

    Live birth rates

  6. FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    Time frame: 2 weeks

    Operating room anesthesia time.

  7. FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    Time frame: 2 weeks

    Luteal E2 level.

  8. FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS

    Time frame: 2 weeks

    Luteal P4 level.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Follicular Flushing on Cycle Outcomes in Poor Responders

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2012
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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