Second Ejaculate and IUI

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: Not yet recruiting
• Conditions: Pregnancy Rate; Sperm Count
• Intervention / Treatment: Behavioral: second ejaculate

• Study Type: Observational
• Enrollment (Anticipated): 410

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen Memorial Hospital
      • Contact: haiyan lin, doctor; Phone Number: +8615913154456; Email: linhaiyan_818@163.com
      • Contact: jin li, master; Phone Number: +8613570200593; Email: lijin2003@qq.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Time Frame
pregnacy rate	2021-8-20~2024.12.30

Secondary Outcome Measures

Outcome Measure	Time Frame
Semen concentration	2021-8-20~2024.12.30
semen volume	2021-8-20~2024.12.30
forward movement rate	2021-8-20~2024.12.30
non forward movement rate	2021-8-20~2024.12.30
proportion of immobile sperm	2021-8-20~2024.12.30
total number of motile sperm after treatment.	2021-8-20~2024.12.30
Abortion rate	2021-8-20~2024.12.30

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 10, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID 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