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

Not Applicable

Completed

• Conditions: Male-related fertility treatment; Pregnancy and Childbirth

• Registration Number: ISRCTN99214271
• Lead Sponsor: niversity of Leeds (UK)

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27855103 protocol 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30712901/ results (added 01/09/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35459947/ (added 25/04/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-08
• Study Completion: 2017-09-30
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2772

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Clinical: Live birth at =37 weeks' gestation following the first fresh ICSI treatment<br> 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<br>

Secondary Outcome Measures

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