Follicle SizeNCT05666401
Effect of Duration and Follicle Diameter During Oocyte Pick up on Embryological Parameters
An observational study of Follicle Size and Embryologic Parameters, run by Eurofertil IVF Health Center at 2 sites in Turkey (Türkiye).
Trial summary
Investigators aim to investigate if the time spent for smaller follicles worth to deal with. The difference between follicle groups are recorded for embryological parameters. Results will be analysed for yielding transfer embryo and pregnancy rates between groups. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Follicle Size, Embryologic Parameters, Duration
- What is being tested?
- follicle diameter and duration of procedure
- Type of treatment
- Surgery or procedure
- How many people
- 291 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 19 Mar 2022to 17 Feb 2024
- How long will I take part?
- 18 Months
- 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 20 to 40 years
- Women only
- Adult
Study population: Couples attending to our clinic for IVF - ICSI without history of RIF and severe male factor
Who may be able to join
- 20-40 year old women
Who cannot join
- History of recurrent implantation failure (RIF)
- Known chromosomal abnormality
- Severe male factor and azospermia
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bursa Eurofertil IVF center
Bursa, 16
Eurofertil IVF center
Bursa, 16
About this study
Official title: Does Follicle Diameter and Total Duration Spent for Oocyte Pick up Has Any Effect on Embryological Parameters and Clinical Pregnancy Rates
Investigators aim to investigate if the time spent for smaller follicles worth to deal with. The difference between follicle groups are recorded for embryological parameters. Results will be analysed for yielding transfer embryo and pregnancy rates between groups.
Read the detailed description
There are papers about follicle dimensions and volumes studying their effect on embryologic parameters. But most of these studies are far from practical approach and are not easily applicable, such as 3D volumetric measurement is not feasible for most of the clinics. Also one of the points important for us it to evaluate the duration of the procedure and the possible positive effect of shortening the duration for better results. Investigators plan to measure the follicles just before puncture and arrange two groups. Group 1,follicles with diameter of 17 mm and more, and group 2 follicles between14-17 mm. Maturation, fertilization, cleavage characteristics are recorded. The source of chosen transfer embryo and crio-preserved embryos per cycle is also point of interest.
- Conditions
- Follicle Size, Embryologic Parameters, Duration
- Being tested
- follicle diameter and duration of procedure
- Keywords
- follicle, dimension, IVF, embryological parameters, duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follicle diameter and duration of procedureProcedure or surgery
Also called success rates
to investigate if smaller follicles thrive embryos as the bigger follicles
| Study group | Role | What they receive |
|---|---|---|
| group 1 | follicles with a diameter of 17 mm and more Receives: Procedure: follicle diameter and duration of procedure | |
| group 2 | follicles with a diameter of 14 mm to 17 mm Receives: Procedure: follicle diameter and duration of procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
transfer embryo
comparing groups as the source of transfer embryo
Measured: 5 to 7 days
Secondary outcomes (1)
clinical pregnancy
comparing groups as the source of implanted embryo
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start19 Mar 2022
- Primary completion17 Feb 2024
- Study completion17 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicle SizeStudies 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
- 291 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Eurofertil IVF Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Güler Ergin, Eurofertil IVF Health Center
- Investigators
- gercek aydin, Study director, bursa Eurofertil IVF center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666401
- Sponsor's protocol ID
- Eurofertil-OPU
- Status last verified
- Feb 2024
- First submitted
- 17 Dec 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not decided yet but probably be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Follicle Diameter and Total Duration Spent for Oocyte Pick up Has Any Effect on Embryological Parameters and Clinical Pregnancy Rates
- ClinicalTrials.gov ID
- NCT05666401
- Acronym / sponsor ID
- Eurofertil-OPU
- Conditions
- Follicle Size, Embryologic Parameters, Duration
- Keywords
- follicle, dimension, IVF, embryological parameters, duration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Eurofertil IVF Health CenterUniversity, hospital or other
- Study start
- 19 Mar 2022 (actual)
- Primary completion
- 17 Feb 2024 (actual)
- Study completion
- 17 Feb 2024 (actual)
- First posted
- 27 Dec 2022 (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.
Investigators aim to investigate if the time spent for smaller follicles worth to deal with. The difference between follicle groups are recorded for embryological parameters. Results will be analysed for yielding transfer embryo and pregnancy rates between groups.
Detailed description
There are papers about follicle dimensions and volumes studying their effect on embryologic parameters. But most of these studies are far from practical approach and are not easily applicable, such as 3D volumetric measurement is not feasible for most of the clinics. Also one of the points important for us it to evaluate the duration of the procedure and the possible positive effect of shortening the duration for better results. Investigators plan to measure the follicles just before puncture and arrange two groups. Group 1,follicles with diameter of 17 mm and more, and group 2 follicles between14-17 mm. Maturation, fertilization, cleavage characteristics are recorded. The source of chosen transfer embryo and crio-preserved embryos per cycle is also point of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: follicle diameter and duration of procedurefollicles with a diameter of 17 mm and more |
| group 2 | – | Procedure: follicle diameter and duration of procedurefollicles with a diameter of 14 mm to 17 mm |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Couples attending to our clinic for IVF - ICSI without history of RIF and severe male factor
Key inclusion criteria (1 listed)
- 20-40 year old women
Key exclusion criteria (3 listed)
- History of recurrent implantation failure (RIF)
- Known chromosomal abnormality
- Severe male factor and azospermia
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 |
|---|---|---|
| follicle diameter and duration of procedureAlso: success ratesto investigate if smaller follicles thrive embryos as the bigger follicles | Procedure or surgery | group 1, group 2 |
Primary outcome
transfer embryo
Time frame: 5 to 7 days
comparing groups as the source of transfer embryo
1 secondary outcome
clinical pregnancy
Time frame: 3 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 20 Feb 2024.
- Individual participant dataSharing planned: Undecided. It is not decided yet but probably be available upon request
Related trials for Follicle Size
Not yet recruitingObservational study
Establishing a Minimum Predictive Threshold Follicular Size and Oocyte Retrieval in ICSI Cycle
Female Infertility
Recruiting
Triggering Ovulation at Follicle Size Smaller or Larger Than 17mm in a Modified Natural Cycle
Embryo Transfer
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.
gercek aydin study director
bursa Eurofertil IVF center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicle Size and Embryologic Parameters, run by Eurofertil IVF Health Center at 2 sites 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 1 inclusion and 3 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
transfer embryo (time frame: 5 to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.