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Assesment of Embryo Viability and Re-expansion After Thawing in Blastocyst Stage Embryos

Effect of Embryo Viability and Re-expansion After Thawing in Blastocyst Stage Embryos on Pregnancy Outcomes: Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05474833
Enrollment
500
Registered
2022-07-26
Start date
2022-03-01
Completion date
2024-02-01
Last updated
2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Embryo morphology, Embryo re-expansion, Frozen- thawed embryo transfer

Brief 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.

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.

Interventions

None listed

Sponsors

Akdeniz University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* Embryos at the cleavage stage (D3) * Patients for whom embryo viability and expansion were not evaluated single-blindly by two different embryologists

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy rateThree weeks after each positive pregnancy test resultIn ultrasonography evaluation three weeks after a positive pregnancy result, a clinical pregnancy will be considered in patients with a fetal heartbeat.

Secondary

MeasureTime frameDescription
Positive β-hCG resultsNine days after each embryo transferPositive β-hCG results nine days after embryo transfer.
The effect of re-expansion degrees and viability of embryos on pregnancyThree weeks after each positive pregnancy test resultThe correlation between positive pregnancy results and the degree of embryo re-expansion/collapse in transfer after embryo thawing will be determined.
Optimal time between two assessments of expansionAbout 2 hours between thawing and transferThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactŞAFAK OLGAN, 1
safakolgan@gmail.com00905064068740
Backup ContactARİF C ÖZSİPAHİ, 2
a.canozsipahi@hotmail.com005068301073

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026