InfertilityNCT02277210
Follicular Flushing in Patients With Suboptimal Responses
A study testing Flushing in people with Infertility, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Flushing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to 2 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 42 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age of women <43 years
- Normal uterine cavity on saline sonogram
- Endometrial thickness >=8mm on the day of hCG
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Flushing
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlushingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Flushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy rate
Measured: 10 weeks of gestation
Secondary outcomes (5)
number of oocytes retrieved
Measured: on the day of retrieval
number of embryo available for transfer
Measured: on the day of embryo transfer
clinical pregnancy rate
Measured: 6 weeks of gestation
operation time of the retrieval
Measured: on the day of retrieval
pain score of retrieval
Measured: on the day of retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion2 Jun 2018
- Study completion2 Jun 2018
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Ernest Hung-Yu Ng, The University of Hong Kong
- Investigators
- Ernest HY Ernest Ng, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277210
- Sponsor's protocol ID
- UW14-428
- Status last verified
- Jul 2021
- First submitted
- 25 Oct 2014
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36409927
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02277210
- Acronym / sponsor ID
- UW14-428
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 2 Jun 2018 (actual)
- Study completion
- 2 Jun 2018 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-flushing group | Placebo comparator | Other: FlushingAspiration 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 comparator | Other: Flushingaspiration 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. |
Who may qualify
- Ages
- Up to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age of women <43 years
- Normal uterine cavity on saline sonogram
- Endometrial thickness >=8mm on the day of hCG
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flushingaspiration 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 group, Non-flushing group |
Primary outcome
ongoing pregnancy rate
Time frame: 10 weeks of gestation
5 secondary outcomes
number of oocytes retrieved
Time frame: on the day of retrieval
number of embryo available for transfer
Time frame: on the day of embryo transfer
clinical pregnancy rate
Time frame: 6 weeks of gestation
operation time of the retrieval
Time frame: on the day of retrieval
pain score of retrieval
Time frame: on the day of retrieval
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Derived from this study: PubMed 36409927Georgiou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest HY Ernest Ng, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flushing in people with Infertility, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ongoing pregnancy rate (time frame: 10 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02277210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.