Clinical Pregnancies After Cryopreservation of Donor Oocytes With an Open or Closed Device

Study Overview
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Brief Summary
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This randomized pilot study will assess if there is a difference in clinical pregnancies using donor oocytes cryopreserved in either a closed or a semi-closed vitrification device.

Detailed Description
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Oocyte cryopreservation was optimized by the use of a new technique: vitrification. Vitrification can be performed using either open devices (where the oocytes are in direct contact with the liquid nitrogen) or closed systems (where the oocytes are never in contact with liquid nitrogen). Previous studies have associated the use of open devices to higher oocyte survival rates and better embryo development. However, any beneficial effect on clinical pregnancy rates is yet to be proven. Hence, the objective of this study is to compare the clinical pregnancy rates of open and closed oocyte vitrification devices.

Official Title
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Investigation of the Clinical Pregnancies Obtained After Cryopreservation of Donor Oocytes With an Open or Closed Device

Conditions
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Infertility

Intervention / Treatment
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* Device: Cryotop device
* Device: CBSvit device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: this is a pragmatic randomized clinical trial. Hence, all consenting oocyte recipients will be eligible for the study Exclusion Criteria: women who do not consent or that cannot comprehend the investigational nature of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 47 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: closed device<br>Standard cryopreservation system. | Device: CBSvit device<br>* a different device for oocyte vitrification (with a lower cooling rate)<br>* Other names: CBSvit closed vitrification device (CryoBioSystems vitrification device);|
| Active Comparator: open device<br>New cryopreservation system. | Device: Cryotop device<br>* a different device for oocyte vitrification (with a very high cooling rate)<br>* Other names: Cryotop open vitrification device (Kitazato);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | Pregnancy determined by ultrasound | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | oocyte survival post-warming based on the morphological appearance of the oocytes immediately after warming: degenerated oocytes are non-surviving oocytes; oocytes with a normal morphological appearance are surviving oocytes | 1 week | 
| fertilization | oocyte fertilization post-insemination: the day after oocyte insemination fertilization is checked: if one male and one female pronucleus appear, the oocyte is fertilized. if both nuclei are not present or more nuclei are present, the oocyte is considered not fertilized. | 1 week | 
| embryo development | embryo development post-fertilization: on day 3 of pre-implantation development, the embryo is scored for the number of cells, fragmentation, appearance of nuclei and other embryological parameters: based on these parameters, an embryological score is given to the embryo. On day 5 of development (blastocyst stage) another score is given to the embryo based on the appearance of the trophectoderm and inner cell mass cells. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oocyte cryopreservation, closed vitrification, open vitrification