Male-related fertility treatment Pregnancy and Childbirth
Conditions
Interventions
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 curr
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed