Second Ejaculate and IUI

April 10, 2022 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Sun Yat-sen Memorial Hospital

The WHO operation specification requires men to maintain a 2-7-day ejaculation abstinence period before semen examination, but it does not mention the possibility of obtaining a second sample immediately after the first sample for evaluation, and the significance of the evaluation of the second sample for fertility. There is a certain fluctuation level in sperm concentration detection. Patients with normal previous detection may have lower sperm concentration on the day of IUI, resulting in the trouble of canceling IUI. It is not clear whether patients with previous oligospermia can obtain more sperm with better vitality and improve the success rate of IUI by taking sperm again. Some retrospective studies found that when the semen abstinence period of oligozoospermia men was as short as 40 minutes, the changes of sperm motility and sperm concentration were significantly improved, but there was no difference in the conclusions of other studies. A small number of assisted reproduction studies found that IUI with samples obtained during abstinence period of less than 2 days could obtain better pregnancy rate. However, the quality and sample size of these retrospective studies are limited, the repeatability is not good enough, and the conclusions are still controversial. We designed a randomized controlled study. Semen examination was performed after sperm extraction. If the sperm concentration after treatment was less than 10m, the subjects were included in the study. They were randomly divided into two groups. Group 1 received IUI for pregnancy assistance directly, and group 2 received IUI for pregnancy assistance 1 hour after the first sperm extraction. The two semen were mixed and treated. 205 subjects were included in the two groups. We tried to explore whether secondary sperm extraction in patients with low IUI concentration can improve the success rate of IUI pregnancy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen Memorial Hospital
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

patient who come to sun yat-sen memorial hospital to do IUI

Description

Inclusion Criteria:

- Man

  1. Male infertility (primary or secondary infertility)
  2. Age 22 ~ 80 years old;
  3. Body mass index < 30 kg / m2;
  4. Normal levels of FSH, LH, t and PRL;
  5. Semen concentration and vitality were normal or slightly abnormal (TSC ≥ 10 million / ml, PR ≥ 20%, vitality ≥ 30%), which was consistent with the indication of IUI assisted pregnancy;
  6. On the day of IUI, the male side took the semen and the TSC was less than 10m / ml

Women's standard

  1. Age 20 ~ 40 years old
  2. Body mass index < 30 kg / m2;

3）FSH<10U/L、AMH>1.1ng/ml

4) Bilateral fallopian tubes are unobstructed

Exclusion Criteria:

  • Man

It has performed vasectomy, orchitis, unilateral orchiectomy, ejaculation difficulty, retrograde ejaculation, diabetes, cardiovascular disease, drug treatment of psychological or genetic diseases.

Woman

  1. Previous history of intrauterine adhesion;
  2. Hydrosalpinx;
  3. B-ultrasound suggests that endometriosis cyst may be;

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
second ejaculate group
Behavioral: second ejaculate
group patients received IUI for pregnancy assistance 1 hour after the first sperm extraction. The two semen were mixed and treated.
first ejaculate group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
pregnacy rate
Time Frame: 2021-8-20~2024.12.30
2021-8-20~2024.12.30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Semen concentration
Time Frame: 2021-8-20~2024.12.30
2021-8-20~2024.12.30
semen volume
Time Frame: 2021-8-20~2024.12.30
2021-8-20~2024.12.30
forward movement rate
Time Frame: 2021-8-20~2024.12.30
2021-8-20~2024.12.30
non forward movement rate
Time Frame: 2021-8-20~2024.12.30
2021-8-20~2024.12.30
proportion of immobile sperm
Time Frame: 2021-8-20~2024.12.30
2021-8-20~2024.12.30
total number of motile sperm after treatment.
Time Frame: 2021-8-20~2024.12.30
2021-8-20~2024.12.30
Abortion rate
Time Frame: 2021-8-20~2024.12.30
2021-8-20~2024.12.30

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Second Ejaculate 2021-8-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings