Transfer Strategy in an Oocyte Donation Programme

Study Overview
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Brief Summary
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It has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (D2), it is expressed on day 3 (D3). Without this activation, the embryo can not continue its development. Therefore, it has been suggested that extended culture to blastocyst stage could be an option to identify and better select embryos that have been able to carry out this activation. The purpose of this study is to compare cumulative pregnancy and live birth rates following transfer of cleavage embryos or blastocysts.

Official Title
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Pilot Study of the Best Transfer Strategy in an Oocyte Donation Programme: an Intention to Treat Randomized Controlled Trial

Conditions
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Oocyte Donation, Infertility, Female, Embryo Transfer

Intervention / Treatment
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* Procedure: Blastocyst-stage embryo transfer strategy
* Procedure: Cleavage-stage embryo transfer strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle. Exclusion Criteria: Preimplantation genetic screening or diagnosis cycles. Patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blastocyst-stage embryo transfer strategy<br> | Procedure: Blastocyst-stage embryo transfer strategy<br>* Intra-uterine transfer of blastocist if in cleavage embryo stage the oocyte recipient has a mínimum of 3 availables embryos with at least one of good quality to transfer and also the inta-uterine transfer of cleavage embryo (day 3) when the recipient doesn't have the previous criteria.<br>|
| Active Comparator: Cleavage-stage embryo transfer strategy<br> | Procedure: Cleavage-stage embryo transfer strategy<br>* Inta-uterine transferring of cleavage embryo transfer (day 3 of develpment) in oocyte recipients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative live birth rate | Total number of births considering fresh and frozen thawed embryos transferred | at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative pregnancy rate | Total number of pregnancies confirmed by ultrasound 6 weeks after embryo transfer including fresh and thawed embryos. | at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle |