NCT02277210

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2018

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

3.7 years

First QC Date

October 25, 2014

Last Update Submit

July 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy rate

    10 weeks of gestation

Secondary Outcomes (5)

  • 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

Study Arms (2)

Non-flushing group

PLACEBO COMPARATOR

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

Flushing group

ACTIVE COMPARATOR

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

Interventions

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 groupNon-flushing group

Eligibility Criteria

AgeUp to 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

Location

Related Publications (1)

  • Georgiou EX, Melo P, Cheong YC, Granne IE. Follicular flushing during oocyte retrieval in assisted reproductive techniques. Cochrane Database Syst Rev. 2022 Nov 21;11(11):CD004634. doi: 10.1002/14651858.CD004634.pub4.

MeSH Terms

Conditions

Infertility

Interventions

flushing solution PBSuc 50

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ernest HY Ernest Ng, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 25, 2014

First Posted

October 28, 2014

Study Start

October 1, 2014

Primary Completion

June 2, 2018

Study Completion

June 2, 2018

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations