Spindle transfer for the treatment of infertility problems associated to poor egg quality: a pilot trial
Not Applicable
- Conditions
- Infertility problems associated to impaired embryo development attributed to poor oocyte quality that cannot be overcome with conventional assisted reproduction techniquesPregnancy and Childbirth
- Registration Number
- ISRCTN11455145
- Lead Sponsor
- Institute of Life
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36787873/ Technical feasibility of maternal spindle transfer (added 15/02/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 25
Inclusion Criteria
1. Women under 40 years old
2. Diagnosed with infertility problems associated to impaired embryo development attributed to poor oocyte quality
3. At least two previous in-vitro fertilization (IVF) failed attempts with or without embryo transfer
Exclusion Criteria
1. Women over 40 years old
2. Couples diagnosed with severe male factor infertility
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Blastocyst formation rates evaluated 5/6 days after the egg pickup using a timelapse incubator to monitor the entire embryo development of each embryo until reaching this stage without disturbing the culture conditions<br>2. Clinical pregnancies and implantation rates judged by elevation of hCG levels and ultrasound confirmation of a gestational sac by 2/3 weeks after embryo transfer. Pregnancies will be further confirmed 2/3 weeks later with fetal heartbeat
- Secondary Outcome Measures
Name Time Method 1. Fertilization judged on the next day of the egg pickup and morphokinetic events associated with embryo development evaluated daily during the following 5/6 days of embryo culture in a timelapse incubator<br>2. Aneuploidy rates judged in biopsied cells from the blastocysts obtained by spindle transfer and measured using advanced genetic molecular tests for screening the chromosome numbers a few days after the blastocyst biopsy<br>3. Miscarriage and delivery rates calculated based on the total number of patients that will be diagnosed to be pregnant following the criteria described in the primary outcome