Selection of Non Apoptotic Human Sperm for in Vitro Fertilization by Using Magnetic Activated Cell Sorting (MACS)

NCT03988361 | Unknown

• 1 other identifier: 2018-183
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical study has been organised to help improve the embryo quality in couples having high rate of sperm showing apoptotic signs. For this, the investigators intend to use a procedure (MACS: magnetic-activated cell sorting) that allows the identification and the removal of the apoptotic sperm cells. This procedure will increase the chance of using non-apoptotic sperm during in vitro fertilization via Intracytoplasmic Sperm Injection (ICSI). By using this procedure the investigators aim to increase the rate of embryos with good quality for these particular couples.

Conditions

Infertility, Male

Outcome Measures

Primary Outcomes (1)

• utilization rate

  number of transferred and cryopreserved embryos per mature oocytes

  2 years

Secondary Outcomes (1)

• fertilization rate

  2 years

Study Arms (2)

Control group

Half of the mature oocytes of the same patient will be injected with sperm obtained after DGC only (conventionally semen preparation).

Study group

Half of the mature oocytes of the same patient will be injected with sperm obtained after DGC and MACS. The sperm used in this group is considered to be enriched in non apoptotic cells.

Diagnostic Test: Magnetic Activated Cell Sorting

Interventions

Magnetic Activated Cell Sorting DIAGNOSTIC_TEST

At the moment of ICSI, sibling mature oocytes will be inseminated with spermatozoa from Study group or from Control group. Following ICSI, all the inseminated oocytes will be individually cultured in the same conditions in the same culture dish. The choice of embryo(s) for transfer will be based on embryo quality. The supernumerary good-quality embryos from both arms will be frozen for further use.

Study group

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Couples with poor embryo quality in the previous cycle at Centre of reproductive Medicine -Universitair Ziekenhuis Brussel and minimum 30% DNA fragmentation in the previous diagnostic semen analysis.

You may qualify if:

• Patients with poor embryo quality in the previous cycles:
• Cycles with no embryo transfer due to insufficient embryo quality
• "Freeze all" cycles without cryopreservation
• Cycles with transfer of embryos with fair and/or poor quality
• Previous diagnostic semen analysis with minimum 30% DNA fragmentation
• ICSI cycles with fresh ejaculated semen with ≥1 mil spermatozoa after DGC.
• Minimum 6 mature oocytes after oocyte pick up.

You may not qualify if:

• Cycles with frozen semen sample
• Cycles with testicular sample
• In vitro fertilization (IVF) cycles
• Cycles with pre-implantation genetic diagnosis
• In vitro maturation cycles

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Central Study Contacts

Ileana Mateizel, PhD

CONTACT

003224749119; ileana.mateizel@uzbrussel.be

Elsie Nulens

CONTACT

003228012676; elsie.nulens@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 17, 2019
• Study Start: September 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share