Ejaculation Abstinence Time and Assisted Reproductive Technology Outcomes
NCT ID: NCT06410417
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2024-05-01
2025-08-01
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short abstinence time group
abstinence time is less than 48 hours
Shorten abstinence time
In the experimental group, male ejaculates once on human chorionic gonadotropin trigger day, and can be ejaculated on the second day if ejaculates fail.
routine abstinence time group
Abstinence for 3-7 days
No interventions assigned to this group
Interventions
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Shorten abstinence time
In the experimental group, male ejaculates once on human chorionic gonadotropin trigger day, and can be ejaculated on the second day if ejaculates fail.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
20 Years
45 Years
ALL
Yes
Sponsors
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The First Hospital of Jilin University
OTHER
Responsible Party
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Principal Investigators
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Yueying Zhu, Master
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
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the first hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Vander 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.
Agarwal 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.
Cates 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.
Barbagallo 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.
Barbagallo 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.
Leisegang K, Dutta S. Do lifestyle practices impede male fertility? Andrologia. 2021 Feb;53(1):e13595. doi: 10.1111/and.13595. Epub 2020 Apr 24.
Fedder 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.
Gervasi 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.
Agarwal 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.
Zini 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.
Osman 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.
Gil-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.
Sorensen 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.
Chen 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.
Agarwal A, Gupta S, Du Plessis S, Sharma R, Esteves SC, Cirenza C, Eliwa J, Al-Najjar W, Kumaresan D, Haroun N, Philby S, Sabanegh E. Abstinence Time and Its Impact on Basic and Advanced Semen Parameters. Urology. 2016 Aug;94:102-10. doi: 10.1016/j.urology.2016.03.059. Epub 2016 May 16.
Gupta S, Singh VJ, Fauzdar A, Prasad K, Srivastava A, Sharma K. Short Ejaculatory Abstinence in Normozoospermic Men is Associated with Higher Clinical Pregnancy Rates in Sub-fertile Couples Undergoing Intra-Cytoplasmic Sperm Injection in Assisted Reproductive Technology: A Retrospective Analysis of 1691 Cycles. J Hum Reprod Sci. 2021 Jul-Sep;14(3):273-280. doi: 10.4103/jhrs.jhrs_235_20. Epub 2021 Sep 28.
Periyasamy AJ, Mahasampath G, Karthikeyan M, Mangalaraj AM, Kunjummen AT, Kamath MS. Does duration of abstinence affect the live-birth rate after assisted reproductive technology? A retrospective analysis of 1,030 cycles. Fertil Steril. 2017 Dec;108(6):988-992. doi: 10.1016/j.fertnstert.2017.08.034. Epub 2017 Oct 31.
Sanchez-Martin P, Sanchez-Martin F, Gonzalez-Martinez M, Gosalvez J. Increased pregnancy after reduced male abstinence. Syst Biol Reprod Med. 2013 Oct;59(5):256-60. doi: 10.3109/19396368.2013.790919. Epub 2013 May 8.
Other Identifiers
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2024-HS-035
Identifier Type: -
Identifier Source: org_study_id
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