Follicular Flushing in Patients With Suboptimal Responses

Study Overview
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Brief Summary
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The aim of the present study is to determine the effect of follicular flushing on the ongoing pregnancy rate in patients who developed four or fewer follicles of 14mm following standard ovarian stimulation for IVF.

Detailed Description
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Oocyte aspiration under the guidance of transvaginal ultrasound is an integral part in IVF treatment. Follicular flushing has been advocated. However, subsequent data from randomized trials failed to demonstrate any benefits with routine follicular flushing in normally responding patients. Instead, it has been shown to prolong the operating time, increase the procedure-related pain and analgesics requirement. Most of the IVF centers no longer perform routine follicular flushing in normally responding patients. The potential role of follicular flushing in patients with a limited number of developing follicles is conflicting based on the recently published randomized trials. The aim of the present study is to determine the effect of follicular flushing on the ongoing pregnancy rate in patients who developed four or fewer follicles of 14mm following standard ovarian stimulation for IVF.

Official Title
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Effect of Follicular Flushing on the Ongoing Pregnancy Rate in Patients Who Developed Four or Fewer Follicles of 14mm Following Standard Ovarian Stimulation for In-vitro Fertilization Treatment - A Randomized Controlled Trial.

Conditions
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Infertility

Intervention / Treatment
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* Other: Flushing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of women <43 years Normal uterine cavity on saline sonogram Endometrial thickness >=8mm on the day of hCG Exclusion Criteria: Planned not to have fresh embryo transfer Cycle cancelled prior to hCG administration Natural cycle IVF Presence of hydrosalpinges on scanning which are not surgically treated Presence of endometrial polyps on scanning Undergoing preimplantation genetic diagnosis

Ages Eligible for Study
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Maximum Age: 42 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Non-flushing group<br>Aspiration alone for all follicular larger than 10mm on both sides. Follicular fluid and flushing will be examined by the embryologists to identify any oocytes. | Other: Flushing<br>* aspiration of follicles that are larger than 10 mm on both sides followed by follicular flushing for up to 4 times. Follicular fluid and flushing will be examined by the embryologists to identify any oocytes.<br>|
| Active Comparator: Flushing group<br>aspiration of follicles that are larger than 10 mm on both sides followed by follicular flushing for up to 4 times. Follicular fluid and flushing will be examined by the embryologists to identify any oocytes. | Other: Flushing<br>* aspiration of follicles that are larger than 10 mm on both sides followed by follicular flushing for up to 4 times. Follicular fluid and flushing will be examined by the embryologists to identify any oocytes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate |  | 10 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocytes retrieved |  | on the day of retrieval | 
| number of embryo available for transfer |  | on the day of embryo transfer | 
| clinical pregnancy rate |  | 6 weeks of gestation | 
| operation time of the retrieval |  | on the day of retrieval | 
| pain score of retrieval |  | on the day of retrieval |