Ejaculation Abstinence Time and Assisted Reproductive Technology Outcomes

May 7, 2024 updated by: The First Hospital of Jilin University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jilin
      • Chang chun, Jilin, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short abstinence time group
abstinence time is less than 48 hours
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.
No Intervention: routine abstinence time group
Abstinence for 3-7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pregnancy rate of different abstinence periods in in vitro fertilization.
Time Frame: A year

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
The fertilization rate of different abstinence periods in in vitro fertilization.
Time Frame: A year

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
The high-quality embryo rate of different abstinence periods in in vitro fertilization.
Time Frame: A year

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pregnancy loss rate of different abstinence periods in in vitro fertilization.
Time Frame: 1.5 years

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
The live birth rates of different abstinence periods in in vitro fertilization.
Time Frame: 1.5 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Investigators

  • Principal Investigator: Yueying Zhu, Master, The First Hospital of Jilin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-HS-035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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