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Ejaculation Abstinence Time and Assisted Reproductive Technology Outcomes

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06410417
Enrollment
500
Registered
2024-05-13
Start date
2024-05-01
Completion date
2025-08-01
Last updated
2024-05-13

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

Conditions

Fertilization in Vitro

Keywords

in vitro fertilization, intracytoplasmic sperm injection, Abstinence time, Clinical pregnancy rate, Embryo quality

Brief 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

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

Interventions

BEHAVIORALShorten 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.

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The pregnancy rate of different abstinence periods in in vitro fertilization.A yearAll 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.A yearFertilization 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.A yearHigh-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.

Secondary

MeasureTime frameDescription
The pregnancy loss rate of different abstinence periods in in vitro fertilization.1.5 yearsPregnancy 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.
The live birth rates of different abstinence periods in in vitro fertilization.1.5 yearsLive 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.

Countries

China

Contacts

Primary ContactYueying Zhu, Master
zhuyueying1974@jlu.edu.cn13504308455
Backup ContactYang Yu, doctorate
yuyang0351@jlu.edu.cn13844000361

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026