Clinical Pregnancy RateNCT03350646
Does the Volume of the Embryo Culture Medium During Embryo Transfer Affects the IVF Outcomes?
A study testing Volume of medium during embryo transfer in people with Clinical Pregnancy Rate, run by Aretaieion University Hospital.
Trial summary
The aim of this study was to evaluate if higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.Patients who fulfilled the inclusion criteria and agreed to participate in the study, were randomized, on the day of the embryo transfer, into group A: low… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Pregnancy Rate
- What is being tested?
- Volume of medium during embryo transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jun 2017
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≤ 45y.o.
- BMI≤36 kg/m2,
- Baseline FSH concentration <15 IU/l,
- Ovarian stimulation with the same GnRH antagonist protocol
- Normal uterine cavity with endometrium thickness >7mm and trilaminar morphology at the Time of transfer and semen
- Parameters of >1 million /ml motile spermatozoa with >4% physiological morphology -
Who cannot join
- PGD cycles
- Frozen -thaw cycles
- Natural cycles or patients following different ovarian stimulation protocol were excluded from the study
- -
About this study
Official title: Low Versus High Volume of Culture Medium During Embryo Transfer: a Randomized Clinical Trial.
The aim of this study was to evaluate if higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.Patients who fulfilled the inclusion criteria and agreed to participate in the study, were randomized, on the day of the embryo transfer, into group A: low volume (20-25 μL) and group B: high volume (40-45 μL)
Read the detailed description
The volume of culture medium used for embryo transfer is a variable that has been speculated to affect the IVF outcome. It is known that ultra high volume (>100 μl) of medium during embryo transfer may result in embryo expulsion out of the uterus or ectopic pregnancy. Similarly, some authors advocate that ultra low volume of transferring medium (<10 μl) may negatively affect pregnancy and implantation rates.
However small differences in the volume of the culture medium may favor the outcome of the embryo transfer. The aim of this study was to evaluate if the use higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.
- Conditions
- Clinical Pregnancy Rate
- Being tested
- Volume of medium during embryo transfer
- Keywords
- embryo transfer, volume, culture medium, loading the catheter, clinical pregnancy rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume of medium during embryo transferOther
| Study group | Role | What they receive |
|---|---|---|
| Low volume (20-25 μl) | Other | Low volume (20-25 μl) Receives: Other: Volume of medium during embryo transfer |
| High volume (40-45 μl) | Other | High volume (40-45 μl) Receives: Other: Volume of medium during embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Number of clinical pregnancies expressed per 100 embryo transfer cycles
Measured: 25 days after embryo transfer
Secondary outcomes (2)
Implantation rate
The number of gestational sacs observed divided by the number of embryos transferred.
Measured: 25 days after embryo transfer
Ongoing pregnancy rate
Number of pregnancies till 20 weeks of gestation expressed per 100 embryo transfer cycles
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study startNov 2014
- Primary completionJan 2017
- Study completionJun 2017
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 Clinical Pregnancy RateStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Sigalos, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350646
- Sponsor's protocol ID
- B-74/30-10-2014
- Status last verified
- Nov 2017
- First submitted
- 18 Nov 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sigalos GAlpha, Michalopoulos Y, Kastoras AG, Triantafyllidou O, Vlahos NF. Low versus high volume of culture medium during embryo transfer: a randomized clinical trial. J Assist Reprod Genet. 2018 Apr;35(4):693-699. doi: 10.1007/s10815-017-1099-8. Epub 2017 Dec 12.
PubMed 29234954
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Versus High Volume of Culture Medium During Embryo Transfer: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03350646
- Acronym / sponsor ID
- B-74/30-10-2014
- Conditions
- Clinical Pregnancy Rate
- Keywords
- embryo transfer, volume, culture medium, loading the catheter, clinical pregnancy rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 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 aim of this study was to evaluate if higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.Patients who fulfilled the inclusion criteria and agreed to participate in the study, were randomized, on the day of the embryo transfer, into group A: low volume (20-25 μL) and group B: high volume (40-45 μL)
Detailed description
The volume of culture medium used for embryo transfer is a variable that has been speculated to affect the IVF outcome. It is known that ultra high volume (>100 μl) of medium during embryo transfer may result in embryo expulsion out of the uterus or ectopic pregnancy. Similarly, some authors advocate that ultra low volume of transferring medium (<10 μl) may negatively affect pregnancy and implantation rates.
However small differences in the volume of the culture medium may favor the outcome of the embryo transfer. The aim of this study was to evaluate if the use higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low volume (20-25 μl) | Other | Other: Volume of medium during embryo transferLow volume (20-25 μl) |
| High volume (40-45 μl) | Other | Other: Volume of medium during embryo transferHigh volume (40-45 μl) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≤ 45y.o.
- BMI≤36 kg/m2,
- Baseline FSH concentration <15 IU/l,
- Ovarian stimulation with the same GnRH antagonist protocol
- Normal uterine cavity with endometrium thickness >7mm and trilaminar morphology at the Time of transfer and semen
Key exclusion criteria (4 listed)
- PGD cycles
- Frozen -thaw cycles
- Natural cycles or patients following different ovarian stimulation protocol were excluded from the study
- -
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 |
|---|---|---|
| Volume of medium during embryo transfer | Other | High volume (40-45 μl), Low volume (20-25 μl) |
Primary outcome
Clinical pregnancy rate
Time frame: 25 days after embryo transfer
Number of clinical pregnancies expressed per 100 embryo transfer cycles
2 secondary outcomes
Implantation rate
Time frame: 25 days after embryo transfer
Ongoing pregnancy rate
Time frame: 20 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 27 Nov 2017.
- Derived from this study: PubMed 29234954Sigalos GAlpha, Michalopoulos Y, Kastoras AG, Triantafyllidou O, Vlahos NF. Low versus high volume of culture medium during embryo transfer: a randomized clinical trial. J Assist Reprod Genet. 2018 Apr;35(4):693-699. doi: 10.1007/s10815-017-1099-8. Epub 2017 Dec 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Volume of medium during embryo transfer in people with Clinical Pregnancy Rate, run by Aretaieion University Hospital.
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 6 inclusion and 4 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 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical pregnancy rate (time frame: 25 days after embryo transfer). 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 NCT03350646, 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 27 Nov 2017.