A Trial of Sperm Injection (PICSI) on Miscarriage Rates in Assisted Conception

NCT05762770 | Unknown

• 1 other identifier: 46341
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Physiological intracytoplasmic sperm injection (PICSI) is a technique used to select healthy, mature sperm for use in infertility treatment based on their physiological ability to bind to hyaluronan (HA), a natural compound found in the body. The relationship between sperm and hyaluronan can be used a marker of sperm maturity and optimal fertilising potential; this principle can be observed in vitro using a PICSI sperm selection device. The PICSI Dish contains microdots of hyaluronan, which only mature sperm bind to and these are selected by the embryologist prior to use in the intracytoplasmic sperm injection (ICSI) procedure. Recurrent miscarriages following infertility treatment are mainly idiopathic, but can be linked with increased chromosomal abnormalities. PICSI has been shown to result in better embryo development and reduced chromosomal abnormalities, due to selection of mature sperm with low DNA damage. Therefore, PICSI may be a useful tool for reducing the rate of miscarriage following infertility treatment. The recent HABSelect study investigated treatment outcomes following PICSI, and whilst they concluded no effect on livebirth rate, they found a significant association in their secondary analysis between PICSI and reduced miscarriage rate compared to ICSI. The implications of the HABSelect study deserve to be explored further with miscarriage rate assessed as a primary outcome measure. This proof-of-concept randomised-controlled-trial aims to investigate whether PICSI shows some promise that would merit evaluation in a fully-powered trial to assess its efficacy as an advanced sperm selection method for the reduction of miscarriage rate. Eligible study participants will be patients undergoing fertility treatment using ICSI, who have provided consent for PICSI. Patients will be randomly allocated to two groups: the control group will receive ICSI according to standard protocol, and the intervention group will have additional sperm selection by HA-binding in a PICSI dish.

Conditions

Infertility; Miscarriage

Outcome Measures

Primary Outcomes (1)

• Miscarriage rate

  The primary outcome measure is miscarriage rate, meaning the number of pregnancy losses following biochemical pregnancy (detection of urinary hcGH).

  ≥37 weeks

Secondary Outcomes (6)

• Fertilisation rates

  ≥37 weeks

• Embryo development and quality

  two and three days

• Blastocyst development and quality

  5 and 6 days

• Implantation rate

  6-7 weeks

• Biochemical pregnancy rate

  6-7 weeks

Study Arms (2)

standard ICSI

NO INTERVENTION

Only spermatozoa with a moving tail but no forward motion will be selected for use in ICSI.

PICSI (intervention)

EXPERIMENTAL

Using HA-binding as a sperm selection tool, the intervention group will have sperm selected physiologically prior to ICSI using PICSI dishes, following ORIGIO recommended methods (CooperSurgical, 2021).

Procedure: PICSI

Interventions

PICSI PROCEDURE

Using HA-binding as a sperm selection tool, the intervention group will have sperm selected physiologically prior to ICSI using PICSI dishes, following ORIGIO recommended methods (CooperSurgical, 2021).

PICSI (intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing ICSI as part of their treatment at the Shropshire and Mid-Wales Fertility Centre
• A total of 140 couples coming through for treatment who have consented to the use of
• PICSI in their treatment and participation in the PICSI study
• Both parties providing gametes for use in treatment must give consent to participate in the study

You may not qualify if:

• If testicular or frozen sperm samples are needing to be used

Sponsors & Collaborators

• Shrewsbury and Telford Hospitals NHS Trust: lead
• The Shropshire and Mid Wales Fertility Centre: collaborator

Study Sites (1)

The Shropshire and Mid-Wales Fertility Centre

Shrewsbury, Shropshire, SY1 4RQ, United Kingdom

RECRUITING

Related Publications (3)

• McDowell S, Kroon B, Ford E, Hook Y, Glujovsky D, Yazdani A. Advanced sperm selection techniques for assisted reproduction. Cochrane Database Syst Rev. 2014 Oct 28;(10):CD010461. doi: 10.1002/14651858.CD010461.pub2.

  PMID: 25348679 RESULT

• Lepine S, McDowell S, Searle LM, Kroon B, Glujovsky D, Yazdani A. Advanced sperm selection techniques for assisted reproduction. Cochrane Database Syst Rev. 2019 Jul 30;7(7):CD010461. doi: 10.1002/14651858.CD010461.pub3.

  PMID: 31425620 RESULT

• Hodes-Wertz B, Grifo J, Ghadir S, Kaplan B, Laskin CA, Glassner M, Munne S. Idiopathic recurrent miscarriage is caused mostly by aneuploid embryos. Fertil Steril. 2012 Sep;98(3):675-80. doi: 10.1016/j.fertnstert.2012.05.025. Epub 2012 Jun 7.

  PMID: 22683012 RESULT

MeSH Terms

Conditions

Infertility; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Jason Kasrie, MSc, ANSHCS, FIBMS,

  Shrewsbury & Telford Hospital Trust

  STUDY DIRECTOR

Central Study Contacts

Evie Derbyshire, BSc Hons

CONTACT

01743 261000; evie.derbyshire@nhs.net

Jason Kasrie, MSc, ANSHCS, FIBMS,

CONTACT

01743 261000; j.kasraie@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 10, 2023
• Study Start: March 27, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

GB (1)