Follicular Flushing in Patients With Suboptimal Responses

Not Applicable

Terminated

• Conditions: Infertility
• Interventions: Other: Flushing

• Registration Number: NCT02277210
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-25
• Study First Submitted QC: 2014-10-25
• Study First Posted: 2014-10-28
• Primary Completion: 2018-06-02
• Study Completion: 2018-06-02
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-flushing group	Flushing	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.
Flushing group	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.

Primary Outcome Measures

Name	Time	Method
ongoing pregnancy rate	10 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
number of oocytes retrieved	on the day of retrieval
number of embryo available for transfer	on the day of embryo transfer
operation time of the retrieval	on the day of retrieval
clinical pregnancy rate	6 weeks of gestation
pain score of retrieval	on the day of retrieval

Trial Locations

Locations (1)

Department of Obstetrics and Gynaecology; 🇨🇳 Hong Kong, Hong Kong, China