Fertilization in VitroNCT06410417
Ejaculation Abstinence Time and Assisted Reproductive Technology Outcomes
A study testing Shorten abstinence time in people with Fertilization in Vitro, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if reducing the ejaculation abstinence time can improve the outcome of assisted reproductive technology. The main questions it aims to answer are: Does reducing the duration of ejaculation abstinence improve the clinical pregnancy rate for in vitro fertilization and… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fertilization in Vitro
- What is being tested?
- Shorten abstinence time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The couple is between 20 and 45 years old, and the woman's body mass index is greater than 18.5 and less than 30kg/m2.
- Meet the indications of assisted reproductive technology, agree to use assisted reproductive technology to assist pregnancy and have entered the process.
- The male has normal ejaculation function and plans to provide a semen sample by masturbation method on the day of egg retrieval.
Who cannot join
- Couples with serious infections and major physical diseases, such as HIV.
- The use of testicular sperm for intracytoplasmic sperm injection, such as the azoospermia.
- The use of frozen sperm for assisted reproductive technology.
- Endometriosis, repeated implantation failure, etc.
- There are clear factors affecting semen parameters within 3 months before sperm extraction, including high temperature, contact with chemicals，radiation or drugs that affect sperm, etc.;Previous orchitis/epididymitis, cryptorchidism, receiving radiotherapy and chemotherapy treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first hospital of Jilin University
Changchun, Jilin, 130000
Yueying Zhu, Master, 13504308455, xiqi@jlu.edu.cn
About this study
Official title: The Effect of Reducing Ejaculation Abstinence Time on Assisted Reproductive Technology Outcomes: a Prospective Randomized Controlled Study
The goal of this clinical trial is to learn if reducing the ejaculation abstinence time can improve the outcome of assisted reproductive technology. The main questions it aims to answer are:
Does reducing the duration of ejaculation abstinence improve the clinical pregnancy rate for in vitro fertilization and intracytoplasmic sperm injection? Does reducing the duration of ejaculation abstinence improve embryo quality in in vitro fertilization and intracytoplasmic sperm injection？ Does reducing the duration of ejaculation abstinence affect pregnancy loss and live birth rates in in vitro fertilization and intracytoplasmic sperm injection?
Read more
Researchers will compare less than 48 hours of abstinence time to more than 48 hours, to see if less than 48 hours of abstinence time improved in vitro fertilization outcomes
Participants will:
Control group abstinence for 3-7 days
The experimental group ejaculated once on human chorionic gonadotropin trigger day
Follow up their in vitro fertilization outcomes
Read the detailed description
The goal of this clinical trial is to learn if reducing the ejaculation abstinence time can improve the outcome of assisted reproductive technology.
Group A: Experimental group: ejaculation once within 48 hours before the day of egg retrieval.
Group B: Control group: ejaculation once within 4-7 days before the day of egg retrieval.
There is currently no clear abstinence period for in vitro fertilization, and the usual practice is to refer to the World Health Organization standard for semen testing: abstinence period of 2-7 days.Group A ejaculated once 48 hours before egg retrieval.Group B was the control group, and ejaculation was performed according to the conventional protocol.Most IVF intervals from ovulation initiation to human chorionic gonadotropin trigger day range from 8-11 days, but the fixed time of egg retrieval is 34-37 hours after the trigger day.Therefore, when determining the human chorionic gonadotropin time, it is less than 48 hours before egg retrieval.In the experimental group, male ejaculates once on the trigger day, and can be ejaculated on the second day if ejaculates fail.
Follow up their in vitro fertilization outcomes
- Conditions
- Fertilization in Vitro
- Being tested
- Shorten abstinence time
- Keywords
- in vitro fertilization, intracytoplasmic sperm injection, Abstinence time, Clinical pregnancy rate, Embryo quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shorten abstinence timeBehavioural
In the experimental group, male ejaculates once on human chorionic gonadotropin trigger day, and can be ejaculated on the second day if ejaculates fail.
| Study group | Role | What they receive |
|---|---|---|
| Short abstinence time group | Experimental | abstinence time is less than 48 hours Receives: Behavioral: Shorten abstinence time |
| routine abstinence time group | No intervention | Abstinence for 3-7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pregnancy rate of different abstinence periods in in vitro fertilization.
All participants underwent ultrasound examination four weeks after embryo transfer. A gestational sac was considered a clinical pregnancy (+), while the absence of a gestational sac was considered a non-clinical pregnancy (-).
Clinical pregnancy rate = (number of clinical pregnancy (+) cycles/transplant cycles) ×100%.
The aim was to compare the difference in pregnancy rates between the two groups.
Measured: A year
The fertilization rate of different abstinence periods in in vitro fertilization.
Fertilization rate = (number of fertilized eggs/number of eggs harvested) ×100%.
The above parameters were evaluated by experienced embryologists according to the evaluation criteria and recorded in the medical record.
The aim was to compare the difference in fertilization rate between the two groups.
Measured: A year
The high-quality embryo rate of different abstinence periods in in vitro fertilization.
High-quality embryo rate = (number of high-quality embryos/number of normal fertilized cleavage embryos) ×100%.
The above parameters were evaluated by experienced embryologists according to the evaluation criteria and recorded in the medical record.
The aim was to compare the difference in high-quality embryo rate between the two groups.
Measured: A year
Secondary outcomes (2)
The pregnancy loss rate of different abstinence periods in in vitro fertilization.
Pregnancy loss rate = number of pregnancy loss cycles/transplant cycles ×100%. Follow-up should be conducted for couples who are already clinically pregnant to record any pregnancy loss that occurs within 24 weeks of gestation.
The aim was to compare the difference in pregnancy loss rate between the two groups.
Measured: 1.5 years
The live birth rates of different abstinence periods in in vitro fertilization.
Live birth rate = number of live birth cycles/transplant cycles ×100%. Translation: Continued follow-up is advised for couples who are already clinically pregnant to document the number of live births.
The aim was to compare the difference in live birth rates between the two groups.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 May 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Fertilization in VitroStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yueying Zhu, Master, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410417
- Sponsor's protocol ID
- 2024-HS-035
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, Rienzi L, Sunde A, Schmidt L, Cooke ID, Simpson JL, van der Poel S. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017 Sep;108(3):393-406. doi: 10.1016/j.fertnstert.2017.06.005. Epub 2017 Jul 29.
PubMed 28760517Vander Borght M, Wyns C. Fertility and infertility: Definition and epidemiology. Clin Biochem. 2018 Dec;62:2-10. doi: 10.1016/j.clinbiochem.2018.03.012. Epub 2018 Mar 16.
PubMed 29555319Agarwal A, Mulgund A, Hamada A, Chyatte MR. A unique view on male infertility around the globe. Reprod Biol Endocrinol. 2015 Apr 26;13:37. doi: 10.1186/s12958-015-0032-1.
PubMed 25928197Cates W, Farley TM, Rowe PJ. Worldwide patterns of infertility: is Africa different? Lancet. 1985 Sep 14;2(8455):596-8. doi: 10.1016/s0140-6736(85)90594-x.
PubMed 2863605Barbagallo F, Condorelli RA, Mongioi LM, Cannarella R, Cimino L, Magagnini MC, Crafa A, La Vignera S, Calogero AE. Molecular Mechanisms Underlying the Relationship between Obesity and Male Infertility. Metabolites. 2021 Dec 4;11(12):840. doi: 10.3390/metabo11120840.
PubMed 34940598Barbagallo F, Condorelli RA, Mongioi LM, Cannarella R, Aversa A, Calogero AE, La Vignera S. Effects of Bisphenols on Testicular Steroidogenesis. Front Endocrinol (Lausanne). 2020 Jun 30;11:373. doi: 10.3389/fendo.2020.00373. eCollection 2020.
PubMed 32714277Leisegang K, Dutta S. Do lifestyle practices impede male fertility? Andrologia. 2021 Feb;53(1):e13595. doi: 10.1111/and.13595. Epub 2020 Apr 24.
PubMed 32330362Fedder J. Nonsperm cells in human semen: with special reference to seminal leukocytes and their possible influence on fertility. Arch Androl. 1996 Jan-Feb;36(1):41-65. doi: 10.3109/01485019608987883.
PubMed 8824667Gervasi MG, Visconti PE. Molecular changes and signaling events occurring in spermatozoa during epididymal maturation. Andrology. 2017 Mar;5(2):204-218. doi: 10.1111/andr.12320.
PubMed 28297559Agarwal A, Saleh RA, Bedaiwy MA. Role of reactive oxygen species in the pathophysiology of human reproduction. Fertil Steril. 2003 Apr;79(4):829-43. doi: 10.1016/s0015-0282(02)04948-8.
PubMed 12749418Zini A, Boman JM, Belzile E, Ciampi A. Sperm DNA damage is associated with an increased risk of pregnancy loss after IVF and ICSI: systematic review and meta-analysis. Hum Reprod. 2008 Dec;23(12):2663-8. doi: 10.1093/humrep/den321. Epub 2008 Aug 29.
PubMed 18757447Osman A, Alsomait H, Seshadri S, El-Toukhy T, Khalaf Y. The effect of sperm DNA fragmentation on live birth rate after IVF or ICSI: a systematic review and meta-analysis. Reprod Biomed Online. 2015 Feb;30(2):120-7. doi: 10.1016/j.rbmo.2014.10.018. Epub 2014 Nov 13.
PubMed 25530036Gil-Guzman E, Ollero M, Lopez MC, Sharma RK, Alvarez JG, Thomas AJ Jr, Agarwal A. Differential production of reactive oxygen species by subsets of human spermatozoa at different stages of maturation. Hum Reprod. 2001 Sep;16(9):1922-30. doi: 10.1093/humrep/16.9.1922.
PubMed 11527899Sorensen F, Melsen LM, Fedder J, Soltanizadeh S. The Influence of Male Ejaculatory Abstinence Time on Pregnancy Rate, Live Birth Rate and DNA Fragmentation: A Systematic Review. J Clin Med. 2023 Mar 13;12(6):2219. doi: 10.3390/jcm12062219.
PubMed 36983220Chen GX, Li HY, Lin YH, Huang ZQ, Huang PY, Da LC, Shi H, Yang L, Feng YB, Zheng BH. The effect of age and abstinence time on semen quality: a retrospective study. Asian J Androl. 2022 Jan-Feb;24(1):73-77. doi: 10.4103/aja202165.
PubMed 34747722
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reducing Ejaculation Abstinence Time on Assisted Reproductive Technology Outcomes: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06410417
- Acronym / sponsor ID
- 2024-HS-035
- Conditions
- Fertilization in Vitro
- Keywords
- in vitro fertilization, intracytoplasmic sperm injection, Abstinence time, Clinical pregnancy rate, Embryo quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if reducing the ejaculation abstinence time can improve the outcome of assisted reproductive technology. The main questions it aims to answer are:
Does reducing the duration of ejaculation abstinence improve the clinical pregnancy rate for in vitro fertilization and intracytoplasmic sperm injection? Does reducing the duration of ejaculation abstinence improve embryo quality in in vitro fertilization and intracytoplasmic sperm injection？ Does reducing the duration of ejaculation abstinence affect pregnancy loss and live birth rates in in vitro fertilization and intracytoplasmic sperm injection?
Researchers will compare less than 48 hours of abstinence time to more than 48 hours, to see if less than 48 hours of abstinence time improved in vitro fertilization outcomes
Participants will:
Control group abstinence for 3-7 days
The experimental group ejaculated once on human chorionic gonadotropin trigger day
Follow up their in vitro fertilization outcomes
Detailed description
The goal of this clinical trial is to learn if reducing the ejaculation abstinence time can improve the outcome of assisted reproductive technology.
Group A: Experimental group: ejaculation once within 48 hours before the day of egg retrieval.
Group B: Control group: ejaculation once within 4-7 days before the day of egg retrieval.
There is currently no clear abstinence period for in vitro fertilization, and the usual practice is to refer to the World Health Organization standard for semen testing: abstinence period of 2-7 days.Group A ejaculated once 48 hours before egg retrieval.Group B was the control group, and ejaculation was performed according to the conventional protocol.Most IVF intervals from ovulation initiation to human chorionic gonadotropin trigger day range from 8-11 days, but the fixed time of egg retrieval is 34-37 hours after the trigger day.Therefore, when determining the human chorionic gonadotropin time, it is less than 48 hours before egg retrieval.In the experimental group, male ejaculates once on the trigger day, and can be ejaculated on the second day if ejaculates fail.
Follow up their in vitro fertilization outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short abstinence time group | Experimental | Behavioral: Shorten abstinence timeabstinence time is less than 48 hours |
| routine abstinence time group | No intervention | –Abstinence for 3-7 days |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The couple is between 20 and 45 years old, and the woman's body mass index is greater than 18.5 and less than 30kg/m2.
- Meet the indications of assisted reproductive technology, agree to use assisted reproductive technology to assist pregnancy and have entered the process.
- The male has normal ejaculation function and plans to provide a semen sample by masturbation method on the day of egg retrieval.
Key exclusion criteria (5 listed)
- Couples with serious infections and major physical diseases, such as HIV.
- The use of testicular sperm for intracytoplasmic sperm injection, such as the azoospermia.
- The use of frozen sperm for assisted reproductive technology.
- Endometriosis, repeated implantation failure, etc.
- There are clear factors affecting semen parameters within 3 months before sperm extraction, including high temperature, contact with chemicals，radiation or drugs that affect sperm, etc.;Previous orchitis/epididymitis, cryptorchidism, receiving radiotherapy and chemotherapy treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shorten abstinence timeIn the experimental group, male ejaculates once on human chorionic gonadotropin trigger day, and can be ejaculated on the second day if ejaculates fail. | Behavioural | Short abstinence time group |
Primary outcome
The pregnancy rate of different abstinence periods in in vitro fertilization.
Time frame: A year
All participants underwent ultrasound examination four weeks after embryo transfer. A gestational sac was considered a clinical pregnancy (+), while the absence of a gestational sac was considered a non-clinical pregnancy (-). Clinical pregnancy rate = (number of clinical pregnancy (+) cycles/transplant cycles) ×100%. The aim was to compare the difference in pregnancy rates between the two groups.
The fertilization rate of different abstinence periods in in vitro fertilization.
Time frame: A year
Fertilization rate = (number of fertilized eggs/number of eggs harvested) ×100%. The above parameters were evaluated by experienced embryologists according to the evaluation criteria and recorded in the medical record. The aim was to compare the difference in fertilization rate between the two groups.
The high-quality embryo rate of different abstinence periods in in vitro fertilization.
Time frame: A year
High-quality embryo rate = (number of high-quality embryos/number of normal fertilized cleavage embryos) ×100%. The above parameters were evaluated by experienced embryologists according to the evaluation criteria and recorded in the medical record. The aim was to compare the difference in high-quality embryo rate between the two groups.
2 secondary outcomes
The pregnancy loss rate of different abstinence periods in in vitro fertilization.
Time frame: 1.5 years
The live birth rates of different abstinence periods in in vitro fertilization.
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Results publication: PubMed 28760517Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, Rienzi L, Sunde A, Schmidt L, Cooke ID, Simpson JL, van der Poel S. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017 Sep;108(3):393-406. doi: 10.1016/j.fertnstert.2017.06.005. Epub 2017 Jul 29.
- Results publication: PubMed 29555319Vander Borght M, Wyns C. Fertility and infertility: Definition and epidemiology. Clin Biochem. 2018 Dec;62:2-10. doi: 10.1016/j.clinbiochem.2018.03.012. Epub 2018 Mar 16.
- Results publication: PubMed 25928197Agarwal A, Mulgund A, Hamada A, Chyatte MR. A unique view on male infertility around the globe. Reprod Biol Endocrinol. 2015 Apr 26;13:37. doi: 10.1186/s12958-015-0032-1.
- Results publication: PubMed 2863605Cates W, Farley TM, Rowe PJ. Worldwide patterns of infertility: is Africa different? Lancet. 1985 Sep 14;2(8455):596-8. doi: 10.1016/s0140-6736(85)90594-x.
- Results publication: PubMed 34940598Barbagallo F, Condorelli RA, Mongioi LM, Cannarella R, Cimino L, Magagnini MC, Crafa A, La Vignera S, Calogero AE. Molecular Mechanisms Underlying the Relationship between Obesity and Male Infertility. Metabolites. 2021 Dec 4;11(12):840. doi: 10.3390/metabo11120840.
- Results publication: PubMed 32714277Barbagallo F, Condorelli RA, Mongioi LM, Cannarella R, Aversa A, Calogero AE, La Vignera S. Effects of Bisphenols on Testicular Steroidogenesis. Front Endocrinol (Lausanne). 2020 Jun 30;11:373. doi: 10.3389/fendo.2020.00373. eCollection 2020.
- Results publication: PubMed 32330362Leisegang K, Dutta S. Do lifestyle practices impede male fertility? Andrologia. 2021 Feb;53(1):e13595. doi: 10.1111/and.13595. Epub 2020 Apr 24.
- Results publication: PubMed 8824667Fedder J. Nonsperm cells in human semen: with special reference to seminal leukocytes and their possible influence on fertility. Arch Androl. 1996 Jan-Feb;36(1):41-65. doi: 10.3109/01485019608987883.
- Results publication: PubMed 28297559Gervasi MG, Visconti PE. Molecular changes and signaling events occurring in spermatozoa during epididymal maturation. Andrology. 2017 Mar;5(2):204-218. doi: 10.1111/andr.12320.
- Results publication: PubMed 12749418Agarwal A, Saleh RA, Bedaiwy MA. Role of reactive oxygen species in the pathophysiology of human reproduction. Fertil Steril. 2003 Apr;79(4):829-43. doi: 10.1016/s0015-0282(02)04948-8.
- Results publication: PubMed 18757447Zini A, Boman JM, Belzile E, Ciampi A. Sperm DNA damage is associated with an increased risk of pregnancy loss after IVF and ICSI: systematic review and meta-analysis. Hum Reprod. 2008 Dec;23(12):2663-8. doi: 10.1093/humrep/den321. Epub 2008 Aug 29.
- Results publication: PubMed 25530036Osman A, Alsomait H, Seshadri S, El-Toukhy T, Khalaf Y. The effect of sperm DNA fragmentation on live birth rate after IVF or ICSI: a systematic review and meta-analysis. Reprod Biomed Online. 2015 Feb;30(2):120-7. doi: 10.1016/j.rbmo.2014.10.018. Epub 2014 Nov 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yueying Zhu, Master principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shorten abstinence time in people with Fertilization in Vitro, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueying Zhu, Master (13504308455, zhuyueying1974@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pregnancy rate of different abstinence periods in in vitro fertilization. (time frame: A year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06410417, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.