Invitro FertilizationNCT03831542
Effect of Follicular Flushing in Patients With Mono-follicular Growth Undergoing In Vitro Fertilization
An observational study of Invitro Fertilization and Diminished Ovarian Reserve, run by Centrum Clinic IVF Center at 1 site in Turkey (Türkiye).
Trial summary
Retrieval of an oocyte from a follicle relies on the release of the cumulus-oocyte-complex (COC) from the follicular wall into the lumen, thereby allowing aspiration by a needle. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Invitro Fertilization, Diminished Ovarian Reserve, Oocyte
- What is being tested?
- direct follicular aspiration and follicular flushing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2019to 6 May 2019
- Phase
- Observational
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women undergoing oocyte retrieval procedure due to primary infertility
Who may be able to join
- women aged 18-40 years
- primary infertility
- diminished ovarian reserve with single mature follicle on the day of oocyte retrieval
Who cannot join
- natural cycle IVF
- presence of endometriosis/endometrioma(s)
- Absence of cumulus oocyte complex following oocyte retrieval
- Severe male factor infertility
- Pre-implantation genetic screening cycles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follicular Flushing in Patients With Mono-follicular Growth
Retrieval of an oocyte from a follicle relies on the release of the cumulus-oocyte-complex (COC) from the follicular wall into the lumen, thereby allowing aspiration by a needle. Flushing the follicle with multiple aspirations from the same follicle is used as a means to increase the ratio of COC per aspirated follicle. Data showed that follicular flushing is not superior to direct aspiration either in normally responding patients or in poor responders undergoing in vitro fertilization (IVF). There is no data in the literature regarding the issue in patients with mono-follicular growth. Direct aspiration or repeatedly flushing the follicle for those with a single follicle will be investigated.
Read the detailed description
Oocyte retrieval procedure This study aims to evaluate the effect of follicular flushing during oocyte retrieval procedure in patients with only one follicle. Double lumen needle will be used and direct follicular aspiration without flushing will be performed for all patients. If an oocyte will be obtained, the patient will be assigned to group A. If not, at least 1 course of follicular flushing will be used until retrieval of an oocyte and the patient will be assigned to group B.
- Conditions
- Invitro Fertilization, Diminished Ovarian Reserve, Oocyte
- Being tested
- direct follicular aspiration, follicular flushing
- Keywords
- follicular flushing, double lumen needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct follicular aspirationBehavioural
direct follicular aspiration
follicular flushingBehavioural
follicular flushing
| Study group | Role | What they receive |
|---|---|---|
| direct aspiration group | Transvaginal ultrasound-guided oocyte retrieval was performed 36 hours after ovulation trigger. A 17-gauge double lumen needle will be used to aspirate a single follicle without flushing. If an oocyte is obtained, the subject will be assigned to group 1. If not, operator will proceed with follicular flushing. Receives: Behavioral: direct follicular aspiration | |
| flushing group | If an oocyte is not obtained with direct aspiration, operator will proceed to follicular flushing and the subject will be assigned to group 2 if an oocyte is obtained following follicular flushing. Receives: Behavioral: follicular flushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
mature oocyte
Confirmation of cumulus oocyte complex (COC) after microscopic examination of follicular fluid by a senior embryologist for each patient.
Measured: during oocyte retrieval procedure
Secondary outcomes (2)
fertilization rate after micro-injection
Confirmation of pronuclei formation on the following day of microinjection by a senior embryologist in each patient.
Measured: 24 hours after microinjection procedure
clinical pregnancy rate per embryo transfer
Confirmation of fetal cardiac activity on 5th or 6th week of gestation by a senior obstetrician in each pregnancy case.
Measured: untill 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start19 Feb 2019
- Primary completion5 May 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Invitro FertilizationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centrum Clinic IVF Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Göksan Pabuçcu, Centrum Clinic IVF Center
- Investigators
- Emre Pabuccu, MD, Study director, Centrum Clinic IVF Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831542
- Sponsor's protocol ID
- 1
- Status last verified
- May 2019
- First submitted
- 2 Feb 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
von Horn K, Depenbusch M, Schultze-Mosgau A, Griesinger G. Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen aspiration needle in IVF patients with poor ovarian response. Hum Reprod. 2017 Apr 1;32(4):832-835. doi: 10.1093/humrep/dex019.
PubMed 28333185Haydardedeoglu B, Gjemalaj F, Aytac PC, Kilicdag EB. Direct aspiration versus follicular flushing in poor responders undergoing intracytoplasmic sperm injection: a randomised controlled trial. BJOG. 2017 Jul;124(8):1190-1196. doi: 10.1111/1471-0528.14629. Epub 2017 May 2.
PubMed 28276148
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Flushing in Patients With Mono-follicular Growth
- ClinicalTrials.gov ID
- NCT03831542
- Acronym / sponsor ID
- 1
- Conditions
- Invitro Fertilization, Diminished Ovarian Reserve, Oocyte
- Keywords
- follicular flushing, double lumen needle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centrum Clinic IVF CenterUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 6 Feb 2019 (actual)
- 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.
Retrieval of an oocyte from a follicle relies on the release of the cumulus-oocyte-complex (COC) from the follicular wall into the lumen, thereby allowing aspiration by a needle. Flushing the follicle with multiple aspirations from the same follicle is used as a means to increase the ratio of COC per aspirated follicle. Data showed that follicular flushing is not superior to direct aspiration either in normally responding patients or in poor responders undergoing in vitro fertilization (IVF). There is no data in the literature regarding the issue in patients with mono-follicular growth. Direct aspiration or repeatedly flushing the follicle for those with a single follicle will be investigated.
Detailed description
Oocyte retrieval procedure This study aims to evaluate the effect of follicular flushing during oocyte retrieval procedure in patients with only one follicle. Double lumen needle will be used and direct follicular aspiration without flushing will be performed for all patients. If an oocyte will be obtained, the patient will be assigned to group A. If not, at least 1 course of follicular flushing will be used until retrieval of an oocyte and the patient will be assigned to group B.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct aspiration group | – | Behavioral: direct follicular aspirationTransvaginal ultrasound-guided oocyte retrieval was performed 36 hours after ovulation trigger. A 17-gauge double lumen needle will be used to aspirate a single follicle without flushing. If an oocyte is obtained, the subject will be assigned to group 1. If not, operator will proceed with follicular flushing. |
| flushing group | – | Behavioral: follicular flushingIf an oocyte is not obtained with direct aspiration, operator will proceed to follicular flushing and the subject will be assigned to group 2 if an oocyte is obtained following follicular flushing. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women undergoing oocyte retrieval procedure due to primary infertility
Key inclusion criteria (3 listed)
- women aged 18-40 years
- primary infertility
- diminished ovarian reserve with single mature follicle on the day of oocyte retrieval
Key exclusion criteria (5 listed)
- natural cycle IVF
- presence of endometriosis/endometrioma(s)
- Absence of cumulus oocyte complex following oocyte retrieval
- Severe male factor infertility
- Pre-implantation genetic screening cycles
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 |
|---|---|---|
| direct follicular aspirationdirect follicular aspiration | Behavioural | direct aspiration group |
| follicular flushingfollicular flushing | Behavioural | flushing group |
Primary outcome
mature oocyte
Time frame: during oocyte retrieval procedure
Confirmation of cumulus oocyte complex (COC) after microscopic examination of follicular fluid by a senior embryologist for each patient.
2 secondary outcomes
fertilization rate after micro-injection
Time frame: 24 hours after microinjection procedure
clinical pregnancy rate per embryo transfer
Time frame: untill 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Background: PubMed 28333185von Horn K, Depenbusch M, Schultze-Mosgau A, Griesinger G. Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen aspiration needle in IVF patients with poor ovarian response. Hum Reprod. 2017 Apr 1;32(4):832-835. doi: 10.1093/humrep/dex019.
- Results publication: PubMed 28276148Haydardedeoglu B, Gjemalaj F, Aytac PC, Kilicdag EB. Direct aspiration versus follicular flushing in poor responders undergoing intracytoplasmic sperm injection: a randomised controlled trial. BJOG. 2017 Jul;124(8):1190-1196. doi: 10.1111/1471-0528.14629. Epub 2017 May 2.
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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.
Emre Pabuccu, MD study director
Centrum Clinic IVF Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invitro Fertilization and Diminished Ovarian Reserve, run by Centrum Clinic IVF Center at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 7 May 2019. 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 Turkey (Türkiye). 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mature oocyte (time frame: during oocyte retrieval procedure). 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 NCT03831542, which also lists 2 linked publications.
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 7 May 2019.