An interventional study of Morula Vitrification in Infertility, sponsored by Egyptian Foundation of Reproductive Endocrinology. Terminated at 4 sites in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-06-14.
Sponsored by Egyptian Foundation of Reproductive Endocrinology · Not applicable, Interventional, and Other
Comparing the vitrification at Day-4 (morula stage) with the blastocyst stage vitrification outcomes with the transfer of all day 5 after warming seems need evaluation. To the best of our knowledge, there has been no random-controlled trial conducted such comparison. Altogether, this trial is to evaluate the morula stage vitrification to blastocyst vitrification on the ongoing pregnancy rate after ICSI.
Vitrification of human embryos has been a paradigm-shifting procedure for higher survival rate compared with the slow freezing protocol. The evidence is scarce to support superior results for vitrifying certain stages of preimplantation embryos. Anecdotal evidence suggests that blastocyst vitrification is more forgiving than cleavage stages. However, data obtained from the procedure of assisted shrinkage of blastocysts before vitrification show a higher survival rate, suggesting that fluid accumulation insides the blastocyst can be a barrier for cryoprotectant to reach the cells. Although reassuring, whether facilitating the cryoprotectants transfer to cells by the laser-assisted shrinkage or other modalities is completely safe remains elusive. Moreover, other claims compare between day-3 embryos vitrification and blastocyst stage, suggesting no difference exists.
One of the most critical stages in embryo development is the maternal to zygotic genome activation (MZA), which occurs at the 4 to 8 cell stages. Therefore, it seems the morula stage is still cleavage but passed the MZA. Morula in the most grading system has compaction for all or the majority of cells so if vitrified, the morula stage can bypass the earlier stage of vitrification as well as the need for the artificial shrinkage for blastocyst stage. Therefore, comparing the vitrification at Day-4 (morula stage) with the blastocyst stage vitrification outcomes with the transfer of all day 5 after warming seems need evaluation. To the best of our knowledge, there has been no random-controlled trial conducted such comparison. Altogether, this trial is to evaluate the morula stage vitrification to blastocyst vitrification on the ongoing pregnancy rate after ICSI.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 53 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
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Exclusion Criteria:
Other: Morula Vitrification
Other: Morula Vitrification
Evaluating the ongoing pregnancy rate following Morula vitrification compared with Blastocyst Vitrification.
The ongoing pregnancy rate
Continued pregnancy at \> gestational week 12 or more per initiated cycle
Time frame: 12 weeks
Biochemical pregnancy rate
positive b-hCG at ≥ 14 days following embryo transfer per initiated cycle
Time frame: 14 days
Implantation rate
Sacs with a heartbeat on ultrasound per embryo transferred
Time frame: 12 weeks
Cumulative implantation rate
Sacs with a heartbeat on ultrasound per embryo transferred within one year from randomization
Time frame: One year
Clinical pregnancy rate
Sacs with a positive heartbeat on ultrasound at ≥ 7 weeks of gestation per initiated cycle
Time frame: 7 weeks
Cumulative clinical pregnancy rate
Sacs with a positive heartbeat on ultrasound at ≥ 7 weeks of gestation per initiated cycle within one year from randomization
Time frame: One year
Cumulative ongoing pregnancy rate
continued pregnancy after gestational week 12 per initiated cycle within one year from randomization
Time frame: One year
Twin pregnancy rate
≥ two foetuses with a heartbeat per initiated cycle
Time frame: One year
Embryo survival rate after thawing
Blastocyst re-expansion for day 5 vitrified embryo after two hours and blastocyst formation on day 5 for embryo vitrified on day 4
Time frame: Five days of culture
Plan to share: No
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This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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