Improvement of Cell Selection in Reproductive Techniques

Jürgen Weiss

Status: Unknown

Conditions: Infertility

Treatments: Other: Z-Score; Other: Z-Score and computer algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT02610114

REPROLUKS 002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

Z-Score and computer algorithm

Experimental group

Treatment:

Other: Z-Score and computer algorithm

Z-Score

Active Comparator group

Treatment:

Other: Z-Score