Effectiveness of PGT-A: IVF Versus ICSI

NCT03708991 | Completed DMC

• 1 other identifier: 1809-ABU-059-ND
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Genetic Condition

Keywords

IVF; ICSI

Outcome Measures

Primary Outcomes (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.

  7 days

Secondary Outcomes (8)

• mitoscore value: ranges from 10-1500

  1 day

• Maturation rate

  1 day

• Morphokinetic development

  7 days

• Fertilization rate

  1 day

• Embryo development up to day 3

  3 days

Other Outcomes (7)

• sperm concentration

  1 day

• sperm motility

  1 day

• Controlled ovarian stimulation: dosage

  2 weeks

Study Arms (2)

IVF combined with PGT-A

5000-10000 motile sperm will be added to the oocyte

Diagnostic Test: IVF combined with PGT-A

ICSI combined with PGT-A

1 motile sperm will be injected into the oocyte

Diagnostic Test: ICSI combined with PGT-A

Interventions

IVF combined with PGT-A DIAGNOSTIC_TEST

trophectoderm biopsy to test the ploidy state of the IVF embryos

IVF combined with PGT-A

ICSI combined with PGT-A DIAGNOSTIC_TEST

trophectoderm biopsy to test the ploidy state of the ICSI embryos

ICSI combined with PGT-A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

IVI RMA Abu Dhabi

Abu Dhabi, United Arab Emirates

Location

Related Publications (4)

• 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.

  PMID: 29897449 BACKGROUND

• 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.

  PMID: 28656917 RESULT

• 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.

  PMID: 28612309 RESULT

• 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.

  PMID: 32086522 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Trophectoderm biopsies from human blastocysts to determine the ploidy state

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Neelke De Munck, PhD

  IVIRMA Abu Dhabi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 17, 2018
• Study Start: November 8, 2018
• Primary Completion: April 24, 2019
• Study Completion: August 4, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

AE (1)