Extrait

Background and study aims In vitro fertilization (IVF) is a technique that helps people who have trouble getting pregnant have a baby. This involves an egg being taken from a women’s ovary and fertilized with sperm in a laboratory. The fertilized egg (embryo) is then put into a women’s uterus to grow (transferred). If there are problems with a woman’s eggs, she can use donated eggs from a healthy woman. Eggs can be stored and saved through the process of rapidly freezing them (vitrification). The success rates of producing a pregnancy from a donated egg can vary, as the eggs have to defrost. This process can cause for the embryo to harden making it unable to hatch (break out of its outer layer that surrounds it) and implant itself into the uterus. A new procedure that assists the hatching process has shown positive, but mixed, results in assisting implantation in the uterus (assisted hatching). This process uses lasers to create an opening in the outer layer allowing the embryo to implant more easily. This study aims to evaluate the techniques used to assist with the embryo hatching from donated vitrified eggs. Who can participate? Women aged up to 50 years who are undergoing their first IVF cycle. What does the study involve? All embryos used in this study are made from vitrified eggs that are thawed, fertilized with sperm and cultured (developed) in the laboratory. Eggs used in this study are from healthy women aged up to 32 years old who have donated their eggs. Egg transfer is done on the fifth day after fertilization, and is transferred to the participant’s uterus through the use of a thin, flexible tube called a catheter. Participants are allocated to one of two groups. Those in the first group are transferred embryos that have assistance hatching. This involves the use of laser pulses two hours before being transferred to create a tiny hole in the outer layer of the embryo. Those in the second group are transferred embryos without assisted hatching. Participants are followed up to see if they are pregnant at 14 days after transfer, 8-10 weeks and 12 weeks after gestation. What are the possible benefits and risks of participating? Participants may benefit from higher pregnancy rates as a result of taking part in the study. Risks of participating include the possibility that the eggs will not survive after warming and discomfort during the transfer process. 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 June 2017 Who is funding the study? Iakentro Advanced Medical Center (Greece) Who is the main contact? Mr Achilleas Papatheodorou

Critère d'inclusion

• Oocyte donation and vitrification

Liens

• isrctn