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Genetic ConditionNCT03708991

Effectiveness of PGT-A: IVF Versus ICSI

An observational study of Genetic Condition, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Genetic Condition
What is being tested?
IVF combined with PGT-A and ICSI combined with PGT-A
How many people
30 participants
Where
1 siteUnited Arab Emirates
Study dates
8 Nov 2018to 4 Aug 2019
How long will I take part?
9 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The study population is defined by all couples seeking a fertility treatment due to primary or secondary infertility in IVI RMA Abu Dhabi, for non-male factor infertility in combination with a PGT-A request.

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • IVI RMA Abu Dhabi

    Abu Dhabi

Other trials in United Arab Emirates

About this study

Official title: Effectiveness of PGT-A by Using IVF Versus ICSI for Non-male Factor Infertility: a Pilot Study

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.

Read the detailed 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.

Being tested
IVF combined with PGT-A, ICSI combined with PGT-A
Keywords
IVF, ICSI
Medical subject headings
Genetic Diseases, Inborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVF combined with PGT-ADiagnostic test

    trophectoderm biopsy to test the ploidy state of the IVF embryos

  • ICSI combined with PGT-ADiagnostic test

    trophectoderm biopsy to test the ploidy state of the ICSI embryos

Study groups in NCT03708991
Study groupRoleWhat they receive
IVF combined with PGT-A5000-10000 motile sperm will be added to the oocyte
Receives: Diagnostic Test: IVF combined with PGT-A
ICSI combined with PGT-A1 motile sperm will be injected into the oocyte
Receives: Diagnostic Test: ICSI combined with PGT-A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ploidy state: euploid or aneuploid

    trophectoderm biopsy performed between day 5-7 of preimplantation development. These cells will be genetically tested to see if the correct number of chromosomes are present. Euploid embryos can be used for the patient, aneuploid embryos cannot be used for the patient.

    Measured: 7 days

Secondary outcomes (8)

  1. mitoscore value: ranges from 10-1500

    the trophectoderm biopsy sample is used to calculate a value indicating the mitochondrial DNA present in the biopt. Lower values are known to be linked to higher implantation rates of the corresponding blastocyst. Higher values have been correlated to aneuploidy.

    Measured: 1 day

  2. Maturation rate

    The maturation rate is defined as the number of mature oocytes obtained per cumulus complex retrieved for the participants.A mature oocyte is defined as an oocyte that has extruded his fiist polar body and this mature oocyte is ready to be fertilized by the participants sperm.

    Measured: 1 day

  3. Morphokinetic development

    As embryos are cultured in a time lapse imaging system, pictures will be taken every 20 minutes to follow the development. Each time that the embryos divides, the timing will be registered in the database. Like this, every division made by every embryo is recorded. the time the embryo needs to go from 1 cell to 2 cells, from 2 cells to 3 cells and so on.

    Measured: 7 days

  4. Fertilization rate

    Fertilization is calculated on all mature oocytes or on all complexes obtained after oocyte retrieval. The fertilization rate is assessed by the presence of a male and a female pronucleus 16-20 hours post fertilization. If the oocyte is fertilized, the outcome is positive, if the oocyte is not fertilized, the outcome is negative.

    Measured: 1 day

  5. Embryo development up to day 3

    For all normally fertilized oocytes the further development will be assessed as the embryos are cultured in a time lapse system. This system takes pictures of the embryos every 20 minutes which shows the development of the embryo like a movie: every time that a cell divides, the hour at which it divides will be registered in the time lapse system. For each cell division, specific time frames have been described that link the embryo to develop into a blastocyst or that increases the chance of implantation. The embryo will be evaluated on day 3 and will receive an embryo score that is based on the number of cells, the appearance of the cells, fragmentation and embryo dysmorphisms. These will divide the embryo quality into 4 categories with category 1 being the highest quality and category 4 being the lowest quality. The more fragmentation and the higher the degree of dysmorphisms, the more the quality will shift to category 4.

    Measured: 3 days

  6. Blastulation rate

    A blastocyst is an embryo in which a cavity is visible on day 5 of the embryo development. If the cavity is present the outcome is positive, if the cavity is absent, the outcome is negative The complete process in which the development of one embryo is followed from the day of injection up until day 7 is called the preimplantation development

    Measured: 7 days

  7. Embryo development up to day 5

    On day 5 of development, a score is given to every embryo. This is based on the presence or absence of a cavity, the number of cells and how tight the cells are packed. The more cells, the higher the grade, if less cells are present, the grade is lower. Based on these parameters, a final grade is calculated (3 grades) with grade 1 being the highest score.

    Measured: 7 days

  8. Pregnancy outcome

    pregnancy outcomes from the frozen embryo transfers: blood samples will be taken and the level of beta-hCG will be measured to define a pregnancy or no pregnancy. A pregnancy is defined as the best oucome. In case a pregnancy is obtained, the patient will come for an ultrasound scan between week 7-12 to checke the presence of a gestational sac and the presence of a fetal heart beat. The presence of a fetal heart beat is defined as a positive outcome, the absence is defined as a negative outcome.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2018
  2. Study start8 Nov 2018
  3. Primary completion24 Apr 2019
  4. Study completion4 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (actual)
Target duration
9 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03708991
Sponsor's protocol ID
1809-ABU-059-ND
Status last verified
Aug 2019
First submitted
8 Oct 2018
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Information regarding primary and secondary outcome measures will only be shared with researchers from the clinic, involved in the study.

Publications

  • Li Z, Wang AY, Bowman M, Hammarberg K, Farquhar C, Johnson L, Safi N, Sullivan EA. ICSI does not increase the cumulative live birth rate in non-male factor infertility. Hum Reprod. 2018 Jul 1;33(7):1322-1330. doi: 10.1093/humrep/dey118.

    PubMed 29897449

  • Sahin L, Bozkurt M, Sahin H, Gurel A, Caliskan E. To compare aneuploidy rates between ICSI and IVF Cases. Niger J Clin Pract. 2017 Jun;20(6):652-658. doi: 10.4103/1119-3077.208959.

    PubMed 28656917

  • Feldman B, Aizer A, Brengauz M, Dotan K, Levron J, Schiff E, Orvieto R. Pre-implantation genetic diagnosis-should we use ICSI for all? J Assist Reprod Genet. 2017 Sep;34(9):1179-1183. doi: 10.1007/s10815-017-0966-7. Epub 2017 Jun 13.

    PubMed 28612309

  • De Munck N, El Khatib I, Abdala A, El-Damen A, Bayram A, Arnanz A, Melado L, Lawrenz B, Fatemi HM. Intracytoplasmic sperm injection is not superior to conventional IVF in couples with non-male factor infertility and preimplantation genetic testing for aneuploidies (PGT-A). Hum Reprod. 2020 Feb 29;35(2):317-327. doi: 10.1093/humrep/deaa002.

    PubMed 32086522

Questions about this trial

What is this clinical trial studying?

An observational study of Genetic Condition, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ploidy state: euploid or aneuploid (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03708991, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.

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