Effectiveness of PGT-A: IVF Versus ICSI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-08

Study Completion Date

2019-08-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Genetic Condition

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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IVF combined with PGT-A

5000-10000 motile sperm will be added to the oocyte

IVF combined with PGT-A

Intervention Type DIAGNOSTIC_TEST

trophectoderm biopsy to test the ploidy state of the IVF embryos

ICSI combined with PGT-A

1 motile sperm will be injected into the oocyte

ICSI combined with PGT-A

Intervention Type DIAGNOSTIC_TEST

trophectoderm biopsy to test the ploidy state of the ICSI embryos

Interventions

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IVF combined with PGT-A

trophectoderm biopsy to test the ploidy state of the IVF embryos

Intervention Type DIAGNOSTIC_TEST

ICSI combined with PGT-A

trophectoderm biopsy to test the ploidy state of the ICSI embryos

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes