Second Ejaculate and IUI

Pregnancy Rate Clinical Trial

Official title:

Sun Yat-sen Memorial Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05173038
• Other study ID #: Second Ejaculate 2021-8-17
• Status: Not yet recruiting
• Start date: May 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2021
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 410
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Gender: Male
• Age group: 22 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Pregnancy Rate

Intervention

Behavioral:
• second ejaculate
group patients received IUI for pregnancy assistance 1 hour after the first sperm extraction. The two semen were mixed and treated.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnacy rate		2021-8-20~2024.12.30
Secondary	Semen concentration		2021-8-20~2024.12.30
Secondary	semen volume		2021-8-20~2024.12.30
Secondary	forward movement rate		2021-8-20~2024.12.30
Secondary	non forward movement rate		2021-8-20~2024.12.30
Secondary	proportion of immobile sperm		2021-8-20~2024.12.30
Secondary	total number of motile sperm after treatment.		2021-8-20~2024.12.30
Secondary	Abortion rate		2021-8-20~2024.12.30