HABSelect: a new sperm selection process for ICSI (Intracytoplasmic Sperm Injection) aimed at increasing live birth outcomes and reducing miscarriage rates

• Register: ISRCTN
• Last refreshed on: 9 May 2022
• Main ID: ISRCTN99214271
• Date of registration: 08/08/2013
• Prospective Registration: Yes
• Primary sponsor: University of Leeds (UK)
• Public title: HABSelect: a new sperm selection process for ICSI (Intracytoplasmic Sperm Injection) aimed at increasing live birth outcomes and reducing miscarriage rates
• Scientific title: Selection of sperm for Assisted Reproductive Treatment by prior hyaluronic acid binding (HABSelect): increasing live birth outcomes and reducing miscarriage rates ? multicentre randomised controlled, blinded trial
• Date of first enrolment: 17/12/2013
• Target sample size: 3730
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN99214271
• Study type: Interventional
• Study design: Parallel-group two-arm multicentre blinded randomised controlled clinical trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: David Miller

Key inclusion & exclusion criteria

Inclusion criteria:
Current exclusion criteria as of 13/01/2015:
1. Couples able to provide informed consent.
2. Couples undergoing first fresh ICSI procedure.
3. Women:
3.1. BMI: 19.0 – 35.0 kg/m2
3.2. FSH level 3.0 – 20.0 miU/ml and/or AMH =1.5 pmol/L
3.3. Age: 18 to 43
4. Men:
4.1. Age: 18 to 55
4.2. Able to produce freshly ejaculated sperm for the treatment cycle

Previous exclusion criteria:
1. Couples able to provide informed consent.
2. Couples undergoing first fresh ICSI procedure
3. Women :
3.1. BMI: 19.0-30.0 kg/m2
3.2. Hormonal level: Anti-Mullerian Hormone (AMH) level 0.8 , 2.5 ng/ml and/or Follicle-Stimulating Hormone (FSH) level 3 , 10 miU/ml
3.3. Age: 18 to 43
4. Men:
4.1. Age: 18 to 55
4.2. Able to produce freshly ejaculated sperm for the treatment cycle

Target Gender: Male & Female; Upper Age Limit 55 years ; Lower Age Limit 18 years

Exclusion criteria:
Current exclusion criteria as of 13/01/2015:
1. Couples who have not consented prior to ICSI will be ineligible
2. Couples using non-ejaculated sperm
3. Couples using donor gametes
4. Men with vasectomy reversal; cancer treatment involving any chemotherapy and/or radiotherapy in the previous two years
5. Previous participation in the HABSelect trial
6. Split IVF/ICSI
7. If both FSH and AMH are tested and either of them falls outside the accepted range

Previous exclusion criteria:
1. Couples using non-ejaculated sperm
2. Couples using donor gametes
3. Men with vasectomy reversal; cancer treatment involving any chemotherapy and/or radiotherapy in the previous two years
4. Previous participation in the HABSelect trial
5. Split IVF/ICSI


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Male-related fertility treatment
Pregnancy and Childbirth

Intervention(s)

PICSI - hyaluronan-based sperm selection system has been approved for clinical use but not introduced into wider practice yet.
Hyaluronan is a natural substance in the body and is currently used for different medical and non-medical purposes. It is also found close to the surface of the egg and thought to be involved into process of sperm selection by the egg for subsequent fertilisation.
1. Hyaluronan coated plates (used in the Intervention Group) make use of that hyaluronan property - the coating binds selectively more mature sperm allowing the embryologist or andrologist to easily pick a sperm for injection.
2. The control (non-intervention) group will receive the current standard treatment, where the sperm is visually selected by the embryologist or andrologist.
The participating couples and their clinical team will be blinded to the study allocation as well as research nurses who follow up the pregnancy outcome of participating females. The study will also collect the sperm left (residual) after ICSI treatment. The research team will perform a series of additional tests on these samples looking in more depth at the way genetic material is packaged in the cell and how its damage correlates with the sperms' ability to bind to hyaluronan and to live birth rate. All the tests performed are established techniques used to research DNA structure and damage in sperm cells.

Primary Outcome(s)

1. Clinical: Live birth at =37 weeks' gestation following the first fresh ICSI treatment
2. Mechanism: HBA score will be recorded on the day of PICSI / PVP-ICSI procedure and DGC washed sperm will be examined, retrospectively for disruption of chromatin architecture and DNA damage

Secondary Outcome(s)

Clinical:
1. Clinical pregnancy rate based on detection of a fetal heartbeat or the presence of fetal sac at 6-9 weeks' gestation
2. Miscarriage, defined as pregnancy loss after confirmation of clinical pregnancy
3. Live birth <37 weeks' gestation

Mechanism: Chromatin disruption in relation to DNA damage and DNA packaging anomalies in 45:90 interface samples and correlation between clinical and post-clinical HBA scores in relation to initial sperm concentration. The relationship between the tests of chromatin and DNA integrity with live birth outcome and miscarriage will be dynamically assessed by statistical modelling

Secondary ID(s)

14845

Source(s) of Monetary Support

National Institute of Health Research - Efficacy and Mechanisms Evaluation (NIIHR-EME) Grant: Ref: 11-14-34-Miller

Ethics review

Status:
Approval date:
Contact:

Yorkshire and The Humber REC: Sheffield, 11/06/2013, ref: 13/YH/0162

Results

• Results available: Yes
• Date Completed: 30/09/2017