Effects of Blastocyst Stage Compared With Cleavage Stage Embryo Transfer in Women Below 39 Years

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Blastocyst Stage Embryo Transfer Compared With Cleavage Stage Embryo Transfer in Women ≤ 38 Years

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Embryo transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patients undergoing IVF procedures age less than 39 years Exclusion Criteria: less than 4 fertilized eggs in day 1 after IVF

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blastocyst<br>Embryo transfer of at maximum 2 embryos at blastocyst stage | Procedure: Embryo transfer<br>* Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage<br>|
| Active Comparator: Cleavage<br>Embryo transfer of at maximum 2 embryos at cleavage stage | Procedure: Embryo transfer<br>* Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Number of patients achieving a clinical pregnancy divided for embryo transfers | 8 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | 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 | 4 weeks after inclusion |