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The effect of shortened ejaculatory abstinence compared to conventional ejaculatory abstinence on sperm DNA fragmentation and in vitro fertilization outcomes: A non-inferiority randomized double-blind clinical trial

The effect of shortened ejaculatory abstinence compared to conventional ejaculatory abstinence on sperm DNA fragmentation and in vitro fertilization outcomes: A non-inferiority randomized double-blind clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260525003
Enrollment
82
Registered
2026-05-25
Start date
2026-06-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short ejaculatory abstinence less than 48 hours with standard abstinence between 2 to 7 days on SDF levels and fertilization outcomes in in vitro fertilization (IVF) cycles Short ejaculatory abstinence, Sperm DNA fragmentation, Fertilization rate, In vitro fertilization (IVF) cycles, Blastocyst rate

Interventions

Participants will be instructed to maintain ejaculatory abstinence for less than 48 hours prior to semen collection (shortened ejaculatory abstinence),Participants will be instructed to maintain ejacu
Experimental Behavioral,Active Comparator Behavioral
Shortened ejaculatory abstinence,Conventional ejaculatory abstinence

Sponsors

Faculty of Medicine, Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Male partner 1.Male partner aged 20 to 45 years with infertility, attending for in vitro fertilization treatment at the Infertility Clinic, Srinagarind Hospital. 2.No history of testicular or penile surgery, or previous vasectomy. 3.No history of cancer, radiotherapy, or chemotherapy. Female partner 1.Female partner aged 20 to 40 years. 2.AntiMullerian hormone level equal or more than 1.2 ng per mL or antral follicle count equal or more than 5 follicles.

Exclusion criteria

Exclusion criteria: Male partner 1.Inability to produce semen by masturbation or requiring surgical sperm retrieval. 2.Severe oligozoospermia, defined as sperm concentration more than 5 million sperms/mL, or azoospermia. 3.Current cigarette smoking more than 20 cigarettes/day, or smoking cessation within the past 3 months. 4.Heavy alcohol intake, defined as more than 80 g/day, equivalent to equal or more than 8 standard drinks/day, for example 6 to 8 cans of beer/day or 5 to 6 shots of liquor/day. 5.Presence of varicocele or other forms of genital heat stress, including high-grade fever or external heat exposure such as sauna, hot bath, working in a high temperature environment, prolonged sitting or driving for equal or more than 2 hours per session, or regular use of very tight underwear or tight trousers. 6.Inflammation or sexually transmitted infection of the male reproductive tract. 7.Metabolic abnormalities, such as impaired glucose tolerance. 8.Obesity, defined as body mass index (BMI) more than 30 kilograms per square meter. Female partner 1.History of endometriosis.

Design outcomes

Primary

MeasureTime frame
Sperm DNA Fragmentation (SDF) Level/index After semen collection (before and after preparation) Percentage of sperm DNA fragmentation measured by validated SDF assay comparing abstinence less than 48 hours with 2 to 7 days,Number of metaphase II oocytes After intracytoplasmic sperm injection Count metaphase II oocytes after intracytoplasmic sperm injection, comparing shortened versus conventional ejaculatory abstinence ,Fertilization rate After intracytoplasmic sperm injection Fertilization rate defined as proportion of 2PN oocytes per total inseminated or injected oocytes comparing shortened versus conventional abstinence,Number of cleavage stage embryos After intracytoplasmic sperm injection day 3 Count embryos in cleavage stage in day 3 after intracytoplasmic sperm injection, comparing shortened versus conventional ejaculatory abstinence,Number of blastocyst embryos After intracytoplasmic sperm injection day 5 Count blastocyst embryos after intracytoplasmic sperm injection day 5, comparing shortened versus conventional ejaculatory abstinence ,Blastocyst Formation and Embryo Quality After intracytoplasmic sperm injection day 5 Number of blastocysts formed and embryo quality assessed using standard morphological grading criteria, comparing shortened versus conventional ejaculatory abstinence

Secondary

MeasureTime frame
Basic Semen Parameters After semen collection (before and after preparation) Semen volume concentration count motility and morphology assessed by WHO semen manual 6th edition comparing shortened versus conventional abstinence

Countries

Thailand

Contacts

Public ContactAchara Pollahan

Faculty of Medicine, Khon Kaen University

Achara1808@gmail.com0872355181

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026