InfertilityNCT05510557
Evaluation of Blastocyst Morphology and Quality in Patients With Embryo Transfer at the Blastocyst Stage
An observational study of Infertility, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
In this prospective study, the investigators aim to investigate the role of trophectoderm cells and inner cell mass cells on pregnancy outcomes in blastocyst transferred in-vitro fertilization pregnancy. 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 May 2022to 30 Nov 2023
- 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: All patients aged 18-40 years who underwent a single freeze-thaw transfer on the 5th day in Akdeniz University Hospital Center for Reproductive Endocrinology and Assisted Reproduction between May 2022 and December 2022 will be included in the study.
Who may be able to join
- Exogenous hormone preparation of the endometrial lining
- Single embryo transfer
- Embryo transfer at the blastocyst stage
Who cannot join
- Double embryo transfer
- Patients who underwent embryo transfer at the cleavage stage
- >15% loss of embryo viability during embryo thawing
- Patients whose data could not be accessed after follow-up or delivery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akdeniz University
Antalya, 07700
Şafak Olgan, MD, +905064068740, safakolgan@gmail.com
Arif C Özsipahi, MD, +905068301073, a.canozsipahi@hotmail.com
About this study
Official title: The Effect of Blastocyst Morphology and Quality on Obstetric Outcomes in Patients Who Underwent Frozen Embryo Transfer at the Blastocyst Stage: Prospective Cohort Study
In this prospective study, the investigators aim to investigate the role of trophectoderm cells and inner cell mass cells on pregnancy outcomes in blastocyst transferred in-vitro fertilization pregnancy. The investigators will support findings with bilateral uterine artery Doppler measurements to be made between the 11th and 14th weeks of pregnancy.
Read the detailed description
Patients scheduled for thawed blastocyst transfer between May 2022 and December 2022 in Akdeniz University Hospital Center for Reproductive Endocrinology and Assisted Reproduction will be included in the study. Embryos that have reached the Blastocyst stage after the ICSI procedure will be examined by a single experienced embryologist using the ALPHA Istanbul consensus evaluation system.
This system includes separating the blastocyst from the zona pellucida - hatching (Grade 1,2,3,4), the size of ICM and arrangement (grade A, B, C), and the number of TE cells and arrangement (grade A, B, C).
Among the embryos whose quality is determined, the best quality embryo belonging to the patient will be transferred single, patients who develop pregnancy after the transfer will be called for follow-ups for uterine artery Doppler measurements to evaluate uteroplacental flow between 11and 14 weeks, and their Doppler measurements will be recorded. By contacting the patients with the phone numbers recorded at the time of the first visit, the weeks of birth, baby weight, gender, and complications that developed during the pregnancy (Abortion, Preeclampsia, Eclampsia, Fetal Growth Restriction, Oligohydramnios, Polyhydramnios, Gestational Diabetes Mellitus and Antenatal Bleeding) will be recorded.
In case the related relationship can be revealed, the risk situations in terms of complications are determined before the transfer, and it is aimed to increase the number of live births together with the risk-based management in the follow-up and screening programs.
- Conditions
- Infertility
- Keywords
- Embryo Morphology, 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.
Live Birth Rate
pregnancy beyond 24 weeks of gestational age.
Measured: 9 months
Obstetric Complication Rates
Conditions such as preeclampsia, eclampsia, fetal growth restriction, oligohydramnios, polyhydramnios, preterm birth, gestational diabetes mellitus, antenatal bleeding and etc. that develop during pregnancy
Measured: 20 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 May 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion30 Nov 2023 (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)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ŞAFAK OLGAN, Akdeniz University
- Investigators
- Şafak Olgan, MD, Principal investigator, 1Arif C Özsipahi, MD, Study chair, 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510557
- Sponsor's protocol ID
- 49849695
- Status last verified
- May 2023
- First submitted
- 19 Aug 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
- The Effect of Blastocyst Morphology and Quality on Obstetric Outcomes in Patients Who Underwent Frozen Embryo Transfer at the Blastocyst Stage: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05510557
- Acronym / sponsor ID
- 49849695
- Conditions
- Infertility
- Keywords
- Embryo Morphology, 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 May 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 22 Aug 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 investigators aim to investigate the role of trophectoderm cells and inner cell mass cells on pregnancy outcomes in blastocyst transferred in-vitro fertilization pregnancy. The investigators will support findings with bilateral uterine artery Doppler measurements to be made between the 11th and 14th weeks of pregnancy.
Detailed description
Patients scheduled for thawed blastocyst transfer between May 2022 and December 2022 in Akdeniz University Hospital Center for Reproductive Endocrinology and Assisted Reproduction will be included in the study. Embryos that have reached the Blastocyst stage after the ICSI procedure will be examined by a single experienced embryologist using the ALPHA Istanbul consensus evaluation system.
This system includes separating the blastocyst from the zona pellucida - hatching (Grade 1,2,3,4), the size of ICM and arrangement (grade A, B, C), and the number of TE cells and arrangement (grade A, B, C).
Among the embryos whose quality is determined, the best quality embryo belonging to the patient will be transferred single, patients who develop pregnancy after the transfer will be called for follow-ups for uterine artery Doppler measurements to evaluate uteroplacental flow between 11and 14 weeks, and their Doppler measurements will be recorded. By contacting the patients with the phone numbers recorded at the time of the first visit, the weeks of birth, baby weight, gender, and complications that developed during the pregnancy (Abortion, Preeclampsia, Eclampsia, Fetal Growth Restriction, Oligohydramnios, Polyhydramnios, Gestational Diabetes Mellitus and Antenatal Bleeding) will be recorded.
In case the related relationship can be revealed, the risk situations in terms of complications are determined before the transfer, and it is aimed to increase the number of live births together with the risk-based management in the follow-up and screening programs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients aged 18-40 years who underwent a single freeze-thaw transfer on the 5th day in Akdeniz University Hospital Center for Reproductive Endocrinology and Assisted Reproduction between May 2022 and December 2022 will be included in the study.
Key inclusion criteria (3 listed)
- Exogenous hormone preparation of the endometrial lining
- Single embryo transfer
- Embryo transfer at the blastocyst stage
Key exclusion criteria (4 listed)
- Double embryo transfer
- Patients who underwent embryo transfer at the cleavage stage
- >15% loss of embryo viability during embryo thawing
- Patients whose data could not be accessed after follow-up or delivery
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
Live Birth Rate
Time frame: 9 months
pregnancy beyond 24 weeks of gestational age.
Obstetric Complication Rates
Time frame: 20 weeks after embryo transfer
Conditions such as preeclampsia, eclampsia, fetal growth restriction, oligohydramnios, polyhydramnios, preterm birth, gestational diabetes mellitus, antenatal bleeding and etc. that develop during pregnancy
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, MD principal investigator
1
Arif C Özsipahi, MD study chair
2
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 3 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: 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, MD (+905064068740, safakolgan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth Rate (time frame: 9 months). The study lists 2 primary outcomes in all. 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.