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Clinical Trials/NCT05474833
NCT05474833
Recruiting
Not Applicable

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

Akdeniz University1 site in 1 country500 target enrollmentMarch 1, 2022
ConditionsInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Akdeniz University
Enrollment
500
Locations
1
Primary Endpoint
Clinical pregnancy rate
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
February 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ŞAFAK OLGAN

associate professor

Akdeniz University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Positive β-hCG results(Nine days after each embryo transfer)
  • The effect of re-expansion degrees and viability of embryos on pregnancy(Three weeks after each positive pregnancy test result)
  • Optimal time between two assessments of expansion(About 2 hours between thawing and transfer)

Study Sites (1)

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