ISRCTN99214271Completed未知
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
niversity of Leeds (UK)0 sites2,772 target enrollmentStarted: August 8, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 2,772
Study Overview
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)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current exclusion criteria as of 13/01/2015:
- •1. Couples able to provide informed consent.
- •2. Couples undergoing first fresh ICSI procedure.
- •3.1. 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
- •4.1. 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
- •4.1. 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
Investigators
Similar Trials
Recruiting
Not Applicable
SprmPik AI Sperm Selection Study SiD, an Assistant for Sperm Selection During Intracytoplasmic Sperm Injection in Medically Assisted Reproduction: Effect on Fertilization, Blastocyst Formation, Early Pregnancy Loss, and Consistent Practice. A Prospective Pilot Study.InfertilityNCT06518928Ovation Fertility155
Completed
Not Applicable
Methods for Objective Selection of Competent SpermSperm SelectionNCT01265329Instituto Valenciano de Infertilidad, IVI VALENCIA237
Unknown
Not Applicable
Automated Sperm Sample Preparation ProtocolInfertilityNCT03999762Nanonc Inc.2,000
Recruiting
Not Applicable
Sex Selection of Human SpermatozoaInfertilityIVFNCT05500573Weill Medical College of Cornell University2,000
Completed
Not Applicable
A Novel Sperm Selection Method Provides Advantages Over Conventional ApproachesMale InfertilityNCT06545318Center of Innovation Technology & Reproductive Medicine115