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Follicular Flushing in Patients With Suboptimal Responses

Primary Purpose

Infertility

Status

Terminated

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Flushing

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

undefined - 42 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Department of Obstetrics and Gynaecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Non-flushing group

Flushing group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

ongoing pregnancy rate

Secondary Outcome Measures

number of oocytes retrieved

number of embryo available for transfer

clinical pregnancy rate

operation time of the retrieval

pain score of retrieval

Full Information

NCT ID

NCT02277210

First Posted

October 25, 2014

Last Updated

July 12, 2021

Sponsor

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT02277210

Brief Title

Follicular Flushing in Patients With Suboptimal Responses

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

poor recruitment

Study Start Date

October 2014 (Actual)

Primary Completion Date

June 2, 2018 (Actual)

Study Completion Date

June 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Hong Kong

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-flushing group

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Flushing group

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Flushing

Intervention Description

Primary Outcome Measure Information:

Title

ongoing pregnancy rate

Time Frame

10 weeks of gestation

Secondary Outcome Measure Information:

Title

number of oocytes retrieved

Time Frame

on the day of retrieval

Title

number of embryo available for transfer

Time Frame

on the day of embryo transfer

Title

clinical pregnancy rate

Time Frame

6 weeks of gestation

Title

operation time of the retrieval

Time Frame

on the day of retrieval

Title

pain score of retrieval

Time Frame

on the day of retrieval

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ernest HY Ernest Ng, MD

Organizational Affiliation

The University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Obstetrics and Gynaecology

City

Hong Kong

State/Province

Hong Kong

Country

China

12. IPD Sharing Statement

Learn more about this trial

Follicular Flushing in Patients With Suboptimal Responses

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