InfertilityNCT03353285
Effect of Follicle Flushing on Oocyte Fertilization Rate
An observational study of Infertility, run by Eugonia at 1 site in Greece.
Trial summary
The purpose of this study is to investigate the impact of follicular flushing on fertilization rate in women undergoing IVF treatment Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- intracytoplasmic sperm injection (ICSI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 27 Nov 2017to 1 Jun 2018
- 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
- Adult
Study population: Women undergoing IVF treatment
Who may be able to join
- Up to 40 years old
- Both ovaries present
- Triggering final oocyte maturation using hCG or GnRH agonist
Who cannot join
- Egg donation
- PGD cases
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Eugonia
Athens, 11528
Tryfon Lainas, PhD, 00302107236333, ivf@eugonia.com.gr
About this study
The purpose of this study is to investigate the impact of follicular flushing on fertilization rate in women undergoing IVF treatment
Read the detailed description
This will be a prospective observational study on the effect of follicular flushing on fertilization rate in women undergoing IVF treatment.
Oocytes from each woman will be allocated to one of three groups, depending on the aspirate or flush they are recovered from:
Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing) Group II= egg retrieved in the 1st-2nd flush Group III= egg retrieved in the 3rd-5th flush
development and utilization. Pregnancy rates will be reported as a surrogate outcome.
- Conditions
- Infertility
- Being tested
- intracytoplasmic sperm injection (ICSI)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracytoplasmic sperm injection (ICSI)Procedure or surgery
All eggs will be fertilized by ICSI
| Study group | Role | What they receive |
|---|---|---|
| Group I | Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing) Receives: Procedure: intracytoplasmic sperm injection (ICSI) | |
| Group II | Group II= egg retrieved in the 1st-2nd flush Receives: Procedure: intracytoplasmic sperm injection (ICSI) | |
| Group III | Group III= egg retrieved in the 3rd-5th flush Receives: Procedure: intracytoplasmic sperm injection (ICSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Number of fertilized eggs per oocyte retrieved
Measured: Day 1 post oocyte retrieval
Secondary outcomes (3)
Maturation rate
Number of mature (MII) eggs per oocyte retrieved
Measured: Day of oocyte retrieval
Good quality embryos
Number of good quality embryos on Day 2
Measured: Day 2 post oocyte retrieval
Blastocyst formation rate
Number of blastocysts on Day 5 per fertilized egg
Measured: Day 5 post oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start27 Nov 2017
- Primary completion31 Jan 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eugonia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tryfon G Lainas, Phd, Study director, Eugonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353285
- Sponsor's protocol ID
- number of flushes
- Status last verified
- Jan 2018
- First submitted
- 21 Nov 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
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 28333185Franasiak JM. Follicular flushing: time to look elsewhere to improve in vitro fertilisation outcomes? BJOG. 2017 Jul;124(8):1197. doi: 10.1111/1471-0528.14628. No abstract available.
PubMed 28276189Roque M, Sampaio M, Geber S. Follicular flushing during oocyte retrieval: a systematic review and meta-analysis. J Assist Reprod Genet. 2012 Nov;29(11):1249-54. doi: 10.1007/s10815-012-9869-9. Epub 2012 Oct 13.
PubMed 23065177
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Follicle Flushing on Oocyte Fertilization Rate
- ClinicalTrials.gov ID
- NCT03353285
- Acronym / sponsor ID
- number of flushes
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- EugoniaUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 27 Nov 2017 (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.
The purpose of this study is to investigate the impact of follicular flushing on fertilization rate in women undergoing IVF treatment
Detailed description
This will be a prospective observational study on the effect of follicular flushing on fertilization rate in women undergoing IVF treatment.
Oocytes from each woman will be allocated to one of three groups, depending on the aspirate or flush they are recovered from:
Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing) Group II= egg retrieved in the 1st-2nd flush Group III= egg retrieved in the 3rd-5th flush
development and utilization. Pregnancy rates will be reported as a surrogate outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Procedure: intracytoplasmic sperm injection (ICSI)Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing) |
| Group II | – | Procedure: intracytoplasmic sperm injection (ICSI)Group II= egg retrieved in the 1st-2nd flush |
| Group III | – | Procedure: intracytoplasmic sperm injection (ICSI)Group III= egg retrieved in the 3rd-5th flush |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women undergoing IVF treatment
Key inclusion criteria (3 listed)
- Up to 40 years old
- Both ovaries present
- Triggering final oocyte maturation using hCG or GnRH agonist
Key exclusion criteria (2 listed)
- Egg donation
- PGD cases
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 |
|---|---|---|
| intracytoplasmic sperm injection (ICSI)All eggs will be fertilized by ICSI | Procedure or surgery | Group I, Group II, Group III |
Primary outcome
Fertilization rate
Time frame: Day 1 post oocyte retrieval
Number of fertilized eggs per oocyte retrieved
3 secondary outcomes
Maturation rate
Time frame: Day of oocyte retrieval
Good quality embryos
Time frame: Day 2 post oocyte retrieval
Blastocyst formation rate
Time frame: Day 5 post oocyte retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- 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.
- Background: PubMed 28276189Franasiak JM. Follicular flushing: time to look elsewhere to improve in vitro fertilisation outcomes? BJOG. 2017 Jul;124(8):1197. doi: 10.1111/1471-0528.14628. No abstract available.
- Background: PubMed 23065177Roque M, Sampaio M, Geber S. Follicular flushing during oocyte retrieval: a systematic review and meta-analysis. J Assist Reprod Genet. 2012 Nov;29(11):1249-54. doi: 10.1007/s10815-012-9869-9. Epub 2012 Oct 13.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Tryfon G Lainas, Phd study director
Eugonia
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 Infertility, run by Eugonia at 1 site in Greece.
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 2 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: status not confirmed, as of the sponsor's last update on 18 Jan 2018. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tryfon G Lainas, PhD (00302107236333, tlainas@eugonia.com.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate (time frame: Day 1 post oocyte retrieval). 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 NCT03353285, which also lists 3 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 18 Jan 2018.