Spindle transfer for the treatment of infertility problems associated to poor egg quality: a pilot trial

Plain English Summary

Background and study aims
Assisted reproductive treatments can be performed to help achieve pregnancy. Poor egg quality is one of the main causes of repeated failures in assisted reproduction treatments. The quality of the eggs is mainly determined by small organelles named mitochondria (the energy suppliers of the cells), together with other factors present in the cytoplasm of the eggs. Unfortunately, many times, patients who are dealing with poor egg quality experience several IVF failed attempts due to impaired embryo development, and have to be treated with conventional egg donation programs to be able to have a child. After years of intense work, a new IVF technique has been developed, named spindle transfer, that allows the replacement of the entire cytoplasm of poor-quality eggs. This procedure is based on transferring the nucleus (containing the genetic material) of the egg from an affected woman, into donor eggs with a healthy cytoplasm which had their nucleus removed. The eggs resulting from the procedure with the repaired cytoplasm can then be inseminated by conventional techniques (ICSI) with the sperm of the patient’s partner, giving the intended parents a chance of having a child genetically related to them. Studies in animals and in human donor eggs donated for research have shown the potential of this technique for the treatment of infertility. The aim of this study is to assess the feasibility of using the spindle transfer technique in patients with poor egg quality undergoing assisted reproductive treatments.

Who can participate?
Women under 40 years old, diagnosed with infertility problems due to poor egg quality, who have had at least two previous failed IVF attempts with or without embryo transfer

What does the study involve?
Participants undergo standard IVF cycle procedures with standard ovarian stimulation. The collected eggs are treated with spindle transfer, inseminated with the patient’s partner's sperm, and screened using advanced genetic methods. Those with the correct number of chromosomes are transferred to the patient's womb. Patients who get pregnant are followed up until delivery and the newborns checked up regularly by paediatricians.

What are the possible benefits and risks of participating?
Participants have the opportunity of being treated with a new IVF procedure that may improve the quality of their eggs and increase their chances of pregnancy and having a baby genetically related to them. If there is no pregnancy, patients are offered the possibility of repeating the cycle or being transferred with embryos produced from non-treated donor eggs. Patients are told that this is a pilot study and, despite animal and human research showing evidence of the safety and effectiveness of the procedures, risks are difficult to specify because of the novelty of the treatment. Moving from research into clinical practice always involves some uncertainty. Assisted reproduction techniques that today are routine in IVF laboratories all involved a degree of uncertainty when they were first performed in humans. Scientific reviews convened by the British Human Fertilisation and Embryology Authority (HFEA) have also come to the conclusion that there is no compelling reason to think that cytoplasm/mitochondrial replacement techniques, like spindle transfer, are unsafe. In order to reduce risks as much as possible the patients are monitored after the treatment.

Where is the study run from?
The Institute of Life – IOLIFE, Athens (Greece)

When is the study starting and how long is it expected to run for?
May 2017 to May 2020

Who is funding the study?
The Institute of Life – IOLIFE, Athens (Greece)

Who is the main contact?
Dr Konstantino Kostaras and Dr Panagiotis Psathas
info@iolife.eu

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Greece

Study participating centre

Sponsor information

Funders

Funder type

Hospital/treatment centre

Results and Publications

Study outputs

Editorial Notes

04/04/2024: Contact details updated.
15/02/2023: Publication reference added.
20/04/2022: The recruitment start date has been changed from 15/02/2018 to 22/02/2018.
04/06/2021: The following changes were made to the trial record:
1. The contact details were updated.
2. The intention to publish date was changed from 31/05/2021 to 31/10/2021.
04/11/2020: The intention to publish date was changed from 31/05/2020 to 31/05/2021.
10/01/2020: The following changes have been made:
1. The overall trial end date has been changed from 01/05/2020 to 01/05/2038.
2. The intention to publish date has been changed from 01/05/2020 to 31/05/2020.
12/12/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 05/02/2020 to 10/12/2019.
2. The overall end date was changed from 01/03/2022 to 01/05/2020.
3. The intention to publish date was changed from 01/03/2023 to 01/05/2020.
4. The total final enrolment was added.
5. The plain English summary was updated to reflect these changes.
03/05/2019: A scientific contact's details have been changed.