Total Motile Sperm Count and Pregnancy Rate From Intrauterine Insemination

NCT05999591 | Completed

• 1 other identifier: OBGY-202308.01
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insemination

Keywords

infertility; intrauterine insemination; post-wash total motile sperm count

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  Pregnancy number divided by number of IUI cycles

  max 9 months

Study Arms (1)

Intrauterine insemination

Patients undergoing intrauterine insemination

Procedure: Intrauterine insemination

Interventions

Intrauterine insemination PROCEDURE

Transfer of sperm into the fallopian tube through a specialised cannula

Intrauterine insemination

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A group of patients undergoing intrauterine insemination for various causes of infertility at a tertiary fertility clinic

You may qualify if:

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

You may not qualify if:

• missing data on pregnancy outcome and missing medical records

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran

Bandung, West Java, 40161, Indonesia

Location

Related 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)01773-9.

  PMID: 12350496 RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Hanom H Syam, M.D., Ph.D

  Department of Obstetrics and Gynecology, Faculty of Medicine Universitas Padjadjaran Bandung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 21, 2023
• Study Start: November 30, 2022
• Primary Completion: December 10, 2022
• Study Completion: January 22, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)