Clinical trial NCT06410417: Ejaculation Abstinence Time and Assisted Reproductive Technology Outcomes
Official title: The Effect of Reducing Ejaculation Abstinence Time on Assisted Reproductive Technology Outcomes: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fertilization in Vitro
Keywords: in vitro fertilization
intracytoplasmic sperm injection
Abstinence time
Clinical pregnancy rate
Embryo quality
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: The pregnancy rate of different abstinence periods in in vitro fertilization.
timeFrame: A year
measure: The fertilization rate of different abstinence periods in in vitro fertilization.
timeFrame: A year
measure: The high-quality embryo rate of different abstinence periods in in vitro fertilization.
timeFrame: A year
Secondary outcomes:
measure: The pregnancy loss rate of different abstinence periods in in vitro fertilization.
timeFrame: 1.5 years
measure: The live birth rates of different abstinence periods in in vitro fertilization.
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Chang chun
country: China
facility: the first hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Yueying Zhu, Master
role: PRINCIPAL_INVESTIGATOR
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