Total Motile Sperm Count and Pregnancy Rate From Intrauterine Insemination

Insemination Clinical Trial

Official title:

Effect of Post-Wash Total Motile Sperm Count on the Pregnancy Rate of Infertility Patients Undergoing Intrauterine Insemination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05999591
• Other study ID #: OBGY-202308.01
• Status: Completed
• Start date: November 30, 2022
• Est. completion date: January 22, 2023

Study information

• Verified date: August 2023
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Intrauterine insemination (IUI) is one of the most important infertility treatments. Infertility is failure to establish pregnancy (>12 months) with regularly unprotected sexual intercourse. Post-wash total motile sperm count (TMSC) vaguely defined as a predictor of IUI pregnancy rate. The minimum value required is also not clear. This study aimed to further define the relationship and determine the minimum recommended value to achieve a satisfactory IUI pregnancy rate. Post-wash TMSC is predictive of IUI success. No optimal cut-off could be identified. In conclusion, post-wash TMSC is highly suggested as a quantitative predictor along with others in counseling and informed consent. The recommended threshold value is >3 x 106.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: January 22, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• post-wash total motile sperm count needed to be over 5 x 10^5

Exclusion Criteria:

• missing data on pregnancy outcome and missing medical records

Related Conditions & MeSH terms

• Infertility
• Insemination

Intervention

Procedure:
• Intrauterine insemination
Transfer of sperm into the fallopian tube through a specialised cannula

Locations

Country	Name	City	State
Indonesia	Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran	Bandung	Jawa Barat

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

Miller DC, Hollenbeck BK, Smith GD, Randolph JF, Christman GM, Smith YR, Lebovic DI, Ohl DA. Processed total motile sperm count correlates with pregnancy outcome after intrauterine insemination. Urology. 2002 Sep;60(3):497-501. doi: 10.1016/s0090-4295(02) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	Pregnancy number divided by number of IUI cycles	max 9 months