Follicular Flushing in Patients With Suboptimal Responses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-06-02

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.

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Non-flushing group

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.

Group Type PLACEBO_COMPARATOR

Flushing

Intervention Type OTHER

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.

Flushing group

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.

Group Type ACTIVE_COMPARATOR

Flushing

Intervention Type OTHER

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.

Interventions

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Flushing

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age of women \<43 years
2. Normal uterine cavity on saline sonogram
3. Endometrial thickness \>=8mm on the day of hCG

Exclusion Criteria

1. Planned not to have fresh embryo transfer
2. Cycle cancelled prior to hCG administration
3. Natural cycle IVF
4. Presence of hydrosalpinges on scanning which are not surgically treated
5. Presence of endometrial polyps on scanning
6. Undergoing preimplantation genetic diagnosis

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No