Study Stopped
poor recruitment
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.
1 other identifier
interventional
4
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 25, 2014
CompletedFirst Posted
Study publicly available on registry
October 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2018
CompletedJuly 16, 2021
July 1, 2021
3.7 years
October 25, 2014
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 COMPARATORAspiration 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
ACTIVE COMPARATORaspiration 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
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.
Eligibility Criteria
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
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.
PMID: 36409927DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ernest HY Ernest Ng, MD
The University of Hong Kong
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