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Single center randomized study including 388 women aged less than 39 years, performing in vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs) improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.
Embryos from in vitro fertilization are routinely transferred into the woman's uterus at cleavage stage (Day 2 to 3) or at blastocyst stage (Day 5 to 6).
The rational of blastocyst stage transfer is that blastocyst stage is the most biologically correct stage for embryos to be in the uterus, and longer culture in the laboratory may give the possibility to reduce the number of genetically abnormal embryos.
The investigators design a single center randomized trial, including 388 women aged less than 39 years, performing in vitro fertilization, to confront blastocyst stage embryo transfers (ETs) and cleavage stage ETs. Each patient is randomized with a non blind randomization, based on a computer model, on the first day after fertilization.
The primary outcomes are implantation and pregnancy rate. The secondary outcome is to verify if blastocyst embryo transfer leads to a higher multiple-pregnancy rate.
An interim analysis takes place at one third of the population. Follow up is of 4 weeks for implantation rate, and covers 8 weeks regarding pregnancy rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blastocyst | Experimental | Embryo transfer of at maximum 2 embryos at blastocyst stage |
|
| Cleavage | Active Comparator | Embryo transfer of at maximum 2 embryos at cleavage stage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embryo transfer | Procedure | Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | Number of patients achieving a clinical pregnancy divided for embryo transfers | 8 weeks after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple pregnancy rate | Number of multiple pregnancies divided for pregnant patients | 8 weeks after inclusion |
| Implantation rate | Number of gestational sacs divided for number of transferred embryos |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Emanuele Levi-Setti, MD | Humanitas Research Hospital Department of Gynecology, Division of Gynecology and Reproductive Medicine Humanitas Fertility Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paolo Emanuele Levi Setti | Rozzano (Milan) | 20089 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22786480 | Background | Glujovsky D, Blake D, Farquhar C, Bardach A. Cleavage stage versus blastocyst stage embryo transfer in assisted reproductive technology. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD002118. doi: 10.1002/14651858.CD002118.pub4. | |
| 29168022 | Derived | Levi-Setti PE, Cirillo F, Smeraldi A, Morenghi E, Mulazzani GEG, Albani E. No advantage of fresh blastocyst versus cleavage stage embryo transfer in women under the age of 39: a randomized controlled study. J Assist Reprod Genet. 2018 Mar;35(3):457-465. doi: 10.1007/s10815-017-1092-2. Epub 2017 Nov 22. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004624 | Embryo Transfer |
| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| 4 weeks after inclusion |