Ejaculation Abstinence Time and Assisted Reproductive Technology Outcomes

Fertilization in Vitro Clinical Trial

Official title:

The Effect of Reducing Ejaculation Abstinence Time on Assisted Reproductive Technology Outcomes: a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410417
• Other study ID #: 2024-HS-035
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: The First Hospital of Jilin University
• Contact: Yueying Zhu, Master
• Phone: 13504308455
• Email: zhuyueying1974[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fertilization in Vitro

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	the first hospital of Jilin University	Chang chun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & Publications (19)

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.urolog — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/meta — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 Reproduc — View Citation

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. — View Citation

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 20 — View Citation

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):98 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	A year
Primary	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.	A year
Primary	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.	A year
Secondary	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.	1.5 years
Secondary	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.	1.5 years