Ejaculation Abstinence Time and Assisted Reproductive Technology Outcomes

Jilin University

Status

Enrolling

Conditions

Fertilization in Vitro

Treatments

Behavioral: Shorten abstinence time

Study type

Interventional

Funder types

Other

Identifiers

NCT06410417

2024-HS-035

Details and patient eligibility

About

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

Full 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

Enrollment

500 estimated patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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