Follicular Flushing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Follicular Flushing on Cycle Outcomes in Poor Responders

Conditions
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Fertilization

Intervention / Treatment
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* Other: Aspiration without flushing follicles with culture media
* Other: Follicular Flushing


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Follicular flushing<br>Flushing follicles with embryo culture media prior to aspiration. | Other: Aspiration without flushing follicles with culture media<br>* Aspiration without flushing follicles with culture media.<br>Other: Follicular Flushing<br>* Flushing follicles with embryo culture media prior to aspiration.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF stimulation., Poor responders., IVF patients with poor response to stimulation