Extrait

Background and study aims About one in six couples suffer from fertility problems (inability to get pregnant). Infertility can be caused by many different factors in the man, the woman or both. Infertility in women is most often related to ovulation (the monthly release of an egg). Healthy women release an egg part-way through their menstrual cycle, which then has the potential to become fertilised by sperm and develop into a baby. In some cases, women are unable to produce eggs at all or can only produce very low quality eggs. A common treatment for this is egg donation. Healthy women under the age of 35 (donors) are able to donate egg cells (oocytes). These oocytes are then implanted in the infertile woman’s (recipient) womb after they have been fertilised with their partner’s sperm. Many women now choose to donate their eggs so that they can be frozen (cryopreservation) in order to be use them at a later date. The egg is the largest cell from the human body and contains a lot of water. In some cases, the freezing process forms ice crystals which destroy the egg. One way to avoid this is to “flash-freeze” the eggs using liquid nitrogen (vitrification). This process can be open (which allows direct contact between the medium (environment) containing the oocytes and the liquid nitrogen), or closed (where this contact is prevented). Currently, most studies which look at the effectiveness of vitrified eggs use the open vitrification system, and so more research is needed to find out whether closed vitrification is just as effective. The aim of this study is to find out whether using eggs frozen using closed vitrification is as safe and effective as using fresh eggs. Who can participate? Donors are healthy women with normal ovaries aged up to 32 years, and recipients are women aged up to 50 years who have not previously received donated eggs. What does the study involve? Each donation cycle (28 days), involves two recipients per donor. Each donor provides two eggs, one of which is frozen using the closed vitrification process. The recipient women are randomly allocated to one of two groups. For women in the first group, a fresh oocyte is fertilised with their partner’s sperm before the resulting embryo is placed (implanted) in the womb. For women in the second group an oocyte which has been frozen using the closed vitrification technique is fertilised with their partner’s sperm before being implanted in the womb. The women in both groups are monitored so that the success rate of the implantation (pregnancy) can be recorded. What are the possible benefits and risks of participating? Participants may benefit from pregnancy as a result of taking part in the study. Risks of participating include the possibility that the oocytes will be lost or will not become fertilized in each cycle. Where is the study run from? Iakentro Advanced Medical Center (Greece) When is the study starting and how long is it expected to run for? January 2014 to December 2014 Who is funding the study? Iakentro Advanced Medical Center (Greece) Who is the main contact? Mr Achilleas Papatheodorou

Critère d'inclusion

• Oocyte Donation

Liens

• isrctn
• ictrp