Effectiveness of PGT-A: IVF Versus ICSI

ART Fertility Clinics LLC

Status

Completed

Conditions

Genetic Condition

Treatments

Diagnostic Test: IVF combined with PGT-A

Diagnostic Test: ICSI combined with PGT-A

Study type

Observational

Funder types

Other

Identifiers

NCT03708991

1809-ABU-059-ND

Details and patient eligibility

About

The investigators want to investigate if the use of conventional in vitro fertilization (IVF) can generate more euploid embryos as compared to intracytoplasmic sperm injection (ICSI).

To verify this, the investigators will inject half of the oocytes by ICSI and the other half of the oocytes will be inseminated by conventional IVF. The most important aim is to see if IVF is able to generate more euploid embryos.

Full description

ICSI is commonly used in pre-implantation genetic testing (PGT) cases to eliminate any risk of sperm DNA contamination. With the switch from cleavage stage biopsy to biopsy of the full (hatching) blastocyst, this potential risk of contamination can be neglected and could allow the use of conventional IVF in PGT cases. Especially in cases of non-male factor infertility, the use of conventional IVF can be applied as a more 'natural' insemination method.

The investigators will perform a pilot study on sibling oocytes including participants with non-male factor infertility and requesting PGT-A (PGT for aneuploidy). If at least 10 cumulus oocyte complexes (COCs) are obtained after oocyte retrieval, half of the oocytes will be subjected to ICSI and the other half to conventional IVF. Preimplantation development is followed by time lapse imaging and blastocysts (day 5-7) fulfilling the biopsy criteria will undergo trophectoderm biopsy to detect the ploidy state and the mitochondrial DNA (mtDNA) copy number.

The main objective is to analyse if the use a more physiological insemination method (IVF) has a beneficial impact on the ploidy state of the blastocyst as compared to ICSI within the same participant. As the embryos will be cultured in a time lapse imaging system, annotations can be made and the differences in maturation rate, fertilization rate and embryo development between both insemination methods can be analysed as secondary outcome parameter. On top of this, the PGT-A outcome will also display the mtDNA copy number which can be compared between IVF and ICSI biopsied sibling blastocyst. Euploid blastocysts will be transferred in subsequent frozen embryo transfer (FET) cycles and give an indication on the clinical outcome between IVF and ICSI.

Enrollment

30 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Sperm parameters Sperm concentration before capacitation: >15*106 per ml (WHO) Total motility (PR+NP,%): >40 (WHO) Progressive motility (PR,%):>32 (WHO) Sperm concentration after capacitation: >0.6*106 per ml (not WHO defined) Progressive motility (PR,%):>65 (WHO)
≥10 COCs after oocyte retrieval
BMI ≤30 kg/m2
Female age 18 to ≤ 40 years
All ovarian stimulation protocols
Fresh ejaculates
Presence or absence of sperm morphology data: as the investigators do not have a diagnostic sperm analysis for all participants, the presence or absence of >4% normal morphology (WHO) will not be taken into account, even with known low (<4%) normal morphology
Couples requesting PGT-A
Arab population

Exclusion criteria

If after denudation (ICSI) only 2 mature oocytes are obtained
If all time lapse spaces are occupied
If the volume to be added after IVF is insufficient to perform IVF on all needed oocytes
Presence of >1 *106 per ml round cells in the ejaculate
If a couple's previous cycle was included in the study