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Influence of Post-thaw Embryo Culture Interval on Assisted Reproduction Success Rates

Influence of Post-thaw Embryo Culture Interval Before Embryo Transfer on Assisted Reproduction Success Rates

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03381001
Enrollment
268
Registered
2017-12-21
Start date
2017-06-15
Completion date
2019-08-10
Last updated
2019-08-14

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

Conditions

Infertility

Keywords

cryopreservation, human embryos, vitrification, embryo culture, embryo transfer, pregnancy rate

Brief summary

The transfer of frozen / thawed embryos has been routinely performed in the last 30 years as part of Assisted Reproduction treatment (ART). Currently, more than 50% of couples submitted to ART have surplus embryos eligible for freezing followed by transfer in subsequent cycles. Therefore the selection criteria for the thawed embryos to be transferred must be rigorous in order to maximize pregnancy and of live birth rates. Usually, the evaluation of the embryos before transfer can be performed based on blastomeres survival after a short culture period between thaw and embryos transfer, i.e., 2 to 5 hours, or based on embryo development over a prolonged period of culture (18h to 24h). Post-thaw embryo culture might have an impact on the recovery of mitosis and normal cellular functions. However, until now, there is no consensus in the literature on which post-thaw culture interval has a better impact on pregnancy and live birth rates. Also, blastocysts formation after freezing/thawing of embryos at cleavage stage may bring relevant information about post-thaw culture. Moreover, this strategy can be used as an alternative treatment. Therefore, the authors proposed this prospective randomized, triple-blind study to evaluate the impact of post-thaw embryo culture on the pregnancy and live birth rates.

Interventions

PROCEDUREembryo transfer after thaw and culture

embryos will be kept in culture after thawing for one day before transfer for the uterus

PROCEDUREembryo transfer with no culture

embryos will be transfer with no culture after thaw

Sponsors

Federal University of Minas Gerais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

prospective, randomized, triple-blinded study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* patients submitted to ART treatment due to infertility that had frozen embryos and need an embryo transfer after endometrial preparation and embryo thawing

Exclusion criteria

* patients that does not reach criteria for frozen embryo transfer (thin endometrium, bleeding, inappropriate use of hormones) * difficult embryo transfer * embryos that were frozen twice

Design outcomes

Primary

MeasureTime frameDescription
pregnancy rates8 weekspercentage of patients that become pregnant after Frozen embryo transfer

Secondary

MeasureTime frameDescription
implantation rate6 weekspercentage of gestational sac according to the number of transferred embryos
embryo development24 hourspercentage of embryos that develop after thawing and before transfer

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026