InfertilityNCT05474833
Assesment of Embryo Viability and Re-expansion After Thawing in Blastocyst Stage Embryos
An observational study of Infertility, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
In this prospective study, the possible effects of embryo viability and degree of blastocele re-expansion on pregnancy outcomes before vitrified/thawed blastocyst transfer will be evaluated. 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
- Infertility
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Feb 2024
- How long will I take part?
- 1 Month
- 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 between the ages of 18 and 40 who underwent IVF treatment
Who may be able to join
- Women aged 18-40 years
- Frozen- thawed embryo transfer cycles
- Only the cycles prepared artificially with hormone replacement therapy.
- Embryos with Day 5 (1CC and higher quality)
Who cannot join
- Embryos at the cleavage stage (D3)
- Patients for whom embryo viability and expansion were not evaluated single-blindly by two different embryologists
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akdeniz University
Antalya
Şafak OLGAN, 1, 00905064068740, safakolgan@gmail.com
Arif C ÖZSİPAHİ, 2, 00905068301073, a.canozsipahi@hotmail.com
About this study
Official title: Effect of Embryo Viability and Re-expansion After Thawing in Blastocyst Stage Embryos on Pregnancy Outcomes: Prospective Cohort Study
In this prospective study, the possible effects of embryo viability and degree of blastocele re-expansion on pregnancy outcomes before vitrified/thawed blastocyst transfer will be evaluated.
Read the detailed description
Thanks to the advances in embryo vitrification technologies in recent years, high embryo viability can be achieved after thawing, and live birth rates increase after the transfer of these embryos.
Embryo morphology is an essential criterion used to predict embryo viability. Blastocysts endure several morphological challenges during vitrification and thawing, including blastocele collapse, cell collapse, and subsequent rehydration. Blastocysts usually collapse immediately after thawing. Because of these morphological changes, cell damage and loss may occur, and morphological integrity may be impaired.
Considering that implantation results may be affected due to supraphysiological high estrogen and progesterone levels due to multi follicular development in the ovaries during fresh embryo transfers, the study is planned to be conducted only in patients who have undergone artificial endometrial preparation with hormone replacement therapy. Only embryos frozen at the blastocyst stage (day 5) will be included in the study.
After embryo thawing, an experienced embryologist will evaluate embryo viability and expansion and record it in the system. Approximately 2 hours after the indicated procedure (just before embryo transfer), embryo viability and degree of re-expansion will be re-evaluated by the 2nd experienced Embryologist. The evaluation results of both embryologists (embryo viability and re-expansion streams) will be known only to the primary clinician (Assoc. Prof. Şafak Olgan). Pregnancy results will be learned nine days after embryo transfer, In ultrasonography evaluation three weeks after a positive pregnancy result, a clinical pregnancy will be considered in patients with fetal heartbeat, and morphological differences between the pregnant and non-pregnant groups will be evaluated.
- Conditions
- Infertility
- Keywords
- Embryo morphology, Embryo re-expansion, Frozen- thawed embryo transfer
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
In ultrasonography evaluation three weeks after a positive pregnancy result, a clinical pregnancy will be considered in patients with a fetal heartbeat.
Measured: Three weeks after each positive pregnancy test result
Secondary outcomes (3)
Positive β-hCG results
Positive β-hCG results nine days after embryo transfer.
Measured: Nine days after each embryo transfer
The effect of re-expansion degrees and viability of embryos on pregnancy
The correlation between positive pregnancy results and the degree of embryo re-expansion/collapse in transfer after embryo thawing will be determined.
Measured: Three weeks after each positive pregnancy test result
Optimal time between two assessments of expansion
The optimal expansion assessment time between thaw and embryo transfer will be determined. The evaluation time interval with the best pregnancy rates will be defined as optimal.
Measured: About 2 hours between thawing and transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Mar 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ŞAFAK OLGAN, Akdeniz University
- Investigators
- ŞAFAK OLGAN, 1, Principal investigator, Akdeniz UniversityARİF C ÖZSİPAHİ, 2, Study chair, Akdeniz UniversitySEFA M CEYLAN, 2, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474833
- Sponsor's protocol ID
- 49849694
- Status last verified
- May 2023
- First submitted
- 23 Jul 2022
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Embryo Viability and Re-expansion After Thawing in Blastocyst Stage Embryos on Pregnancy Outcomes: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05474833
- Acronym / sponsor ID
- 49849694
- Conditions
- Infertility
- Keywords
- Embryo morphology, Embryo re-expansion, Frozen- thawed embryo transfer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 26 Jul 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.
In this prospective study, the possible effects of embryo viability and degree of blastocele re-expansion on pregnancy outcomes before vitrified/thawed blastocyst transfer will be evaluated.
Detailed description
Thanks to the advances in embryo vitrification technologies in recent years, high embryo viability can be achieved after thawing, and live birth rates increase after the transfer of these embryos.
Embryo morphology is an essential criterion used to predict embryo viability. Blastocysts endure several morphological challenges during vitrification and thawing, including blastocele collapse, cell collapse, and subsequent rehydration. Blastocysts usually collapse immediately after thawing. Because of these morphological changes, cell damage and loss may occur, and morphological integrity may be impaired.
Considering that implantation results may be affected due to supraphysiological high estrogen and progesterone levels due to multi follicular development in the ovaries during fresh embryo transfers, the study is planned to be conducted only in patients who have undergone artificial endometrial preparation with hormone replacement therapy. Only embryos frozen at the blastocyst stage (day 5) will be included in the study.
After embryo thawing, an experienced embryologist will evaluate embryo viability and expansion and record it in the system. Approximately 2 hours after the indicated procedure (just before embryo transfer), embryo viability and degree of re-expansion will be re-evaluated by the 2nd experienced Embryologist. The evaluation results of both embryologists (embryo viability and re-expansion streams) will be known only to the primary clinician (Assoc. Prof. Şafak Olgan). Pregnancy results will be learned nine days after embryo transfer, In ultrasonography evaluation three weeks after a positive pregnancy result, a clinical pregnancy will be considered in patients with fetal heartbeat, and morphological differences between the pregnant and non-pregnant groups will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between the ages of 18 and 40 who underwent IVF treatment
Key inclusion criteria (4 listed)
- Women aged 18-40 years
- Frozen- thawed embryo transfer cycles
- Only the cycles prepared artificially with hormone replacement therapy.
- Embryos with Day 5 (1CC and higher quality)
Key exclusion criteria (2 listed)
- Embryos at the cleavage stage (D3)
- Patients for whom embryo viability and expansion were not evaluated single-blindly by two different embryologists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical pregnancy rate
Time frame: Three weeks after each positive pregnancy test result
In ultrasonography evaluation three weeks after a positive pregnancy result, a clinical pregnancy will be considered in patients with a fetal heartbeat.
3 secondary outcomes
Positive β-hCG results
Time frame: Nine days after each embryo transfer
The effect of re-expansion degrees and viability of embryos on pregnancy
Time frame: Three weeks after each positive pregnancy test result
Optimal time between two assessments of expansion
Time frame: About 2 hours between thawing and transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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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.
ŞAFAK OLGAN, 1 principal investigator
Akdeniz University
ARİF C ÖZSİPAHİ, 2 study chair
Akdeniz University
SEFA M CEYLAN, 2 study chair
Akdeniz University
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 Akdeniz University 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 4 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 23 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ŞAFAK OLGAN, 1 (00905064068740, safakolgan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: Three weeks after each positive pregnancy test result). 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 23 May 2023.