A New Method to Improve the Selection of Zygotes in the Context of Assisted Reproductive Medicine. A Randomized Controlled Blinded Monocenter Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Clinical pregnancy
Study Overview
Brief Summary
It is the aim of this trial to use a new computerized cell selection method, in addition to the current and world-wide used scoring system of fertilized oocytes implemented by Scott, to determine whether this leads to an increase in pregnancy rates in women undergoing assisted reproductive techniques.
Detailed Description
It is the aim of this trial to use a new computerized selection method, in addition to the current and world-wide used scoring system of fertilized oocytes (zygotes) implemented by Scott in 1998, to determine whether this leads to an increase in pregnancy rates in women undergoing assisted reproductive techniques. If successful this could in the future lead to a reduction in the numbers of embryos required to achieve a pregnancy. Transferring only one embryo means minimizing the incidence of high order multiple pregnancies.
Regularly couples gain several fertilized oocytes (zygotes) due to artificial reproductive techniques. As a routine, these cells are archived using pictures and videos for quality and safety reasons in different stages of development. Because it is planned to transfer only one or two developed embryos to the uterus, investigators have to select the zygotes with the highest potential for implantation and pregnancy. The remaining cells are preserved using vitrification.
In the study, investigators use in addition to the established Zygote-score (Z-score) by Scott a new selection method for one group of patients: The quality of the zygotes of all patients is classified according to the described Scott system. Patients are randomized to two groups. Group 1 is the control group without any further intervention. If needed for selection, the quality of the zygotes of the patients of group 2 is additionally scored with a new method. The pictures of the cells, already taken for quality and safety reasons, are taken and the cells surface is analysed using a computer algorithm.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(for both male and female, couples):
- •Woman with age 18 years or older
- •Man with age 18 years or older
- •Couples who could gain fertilized cells after In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI) after hormonal stimulation due to sterility treatments
- •Couples presenting negative blood samples of human immunodeficiency virus (HIV) and Hepatitis B/C
- •Signed routine contracts between hospital and patient wanting assisted reproductive technology (ART)
- •Signed informed study consent
- •Expectation of life more than 18 years
- •No medical contraindication to become pregnant (female)
- •Routine criteria for assisted reproductive techniques
Exclusion Criteria
- •(for female):
- •Poor health status acc. to Investigator's judgement
- •Expectation of life below 18 years
- •Risk of ovarian hyperstimulation syndrome
- •Avital cells (cells that do not further develop or die)
- •Treatment due to fertility preservation, e.g. in case of cancer
- •Problems after stimulation and follicle puncture
- •Endometrial pathologies like polyps, submucous fibroids, etc.
- •Any preceding stimulation cycle with endometrial thickness below 6mm
- •Less than 4 fertilized oocytes
- •Patient (and partner) wishes single embryo Transfer
- •Failure to become pregnant with new zygote selection method
Arms & Interventions
Z-Score and computer algorithm
Intervention: Z-Score and computer algorithm (Other)
Z-Score
Intervention: Z-Score (Other)
Outcomes
Primary Outcomes
Clinical pregnancy
Time Frame: min. 4 weeks after embryo transfer
Clinical pregnancy is defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.
Secondary Outcomes
- Ongoing clinical pregnancy(min. 9 weeks after embryo transfer)
- Life Birth(through study completion, an average of 40 weeks after last menstrual period)
Investigators
Jürgen Weiss
Prof. Dr. med.
Luzerner Kantonsspital