Clinical trial NCT02610114: Improvement of Cell Selection in Reproductive Techniques
Official title: A New Method to Improve the Selection of Zygotes in the Context of Assisted Reproductive Medicine. A Randomized Controlled Blinded Monocenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: Assisted reproductive technology (ART)
zygotes
Z-score (Zygote Score)
Infertility
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Clinical pregnancy
timeFrame: min. 4 weeks after embryo transfer
Secondary outcomes:
measure: Ongoing clinical pregnancy
timeFrame: min. 9 weeks after embryo transfer
measure: Life Birth
timeFrame: through study completion, an average of 40 weeks after last menstrual period
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Neue Frauenklinik
Study officials:
affiliation: Luzerner Kantonsspital, Neue Frauenklinik
name: Jürgen Weiss, Professor
role: STUDY_CHAIR
References: