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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474833
• Other study ID #: 49849694
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2023
• Source: Akdeniz University
• Contact: SAFAK OLGAN, 1
• Phone: 00905064068740
• Email: safakolgan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three weeks after each positive pregnancy test result
Secondary	Positive ß-hCG results	Positive ß-hCG results nine days after embryo transfer.	Nine days after each embryo transfer
Secondary	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.	Three weeks after each positive pregnancy test result
Secondary	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.	About 2 hours between thawing and transfer