Follicular Flushing in Patients With Suboptimal Responses

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.

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 Overview

• Status: Terminated
• Conditions: Infertility
• Intervention / Treatment: Other: Flushing

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • Department of Obstetrics and Gynaecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 42 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ongoing pregnancy rate	10 weeks of gestation

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Ernest HY Ernest Ng, MD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): June 2, 2018
• Study Completion (Actual): June 2, 2018

Study Registration Dates

• First Submitted: October 25, 2014
• First Submitted That Met QC Criteria: October 25, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Infertility; Flushing
• Other Study ID Numbers: UW14-428