Total Motile Sperm Count and Pregnancy Rate From Intrauterine Insemination

August 13, 2023 updated by: Universitas Padjadjaran

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

330

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

  • Indonesia
    • Jawa Barat
      • Bandung, Jawa Barat, Indonesia, 40161
        • Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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
Intervention / Treatment
Intrauterine insemination
Patients undergoing intrauterine insemination
Procedure: Intrauterine insemination
Transfer of sperm into the fallopian tube through a specialised cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: max 9 months
Pregnancy number divided by number of IUI cycles
max 9 months

Collaborators and Investigators

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

Sponsor

Universitas Padjadjaran

Investigators

  • Principal Investigator: Hanom H Syam, M.D., Ph.D, Department of Obstetrics and Gynecology, Faculty of Medicine Universitas Padjadjaran Bandung

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 30, 2022

Primary Completion (Actual)

December 10, 2022

Study Completion (Actual)

January 22, 2023

Study Registration Dates

First Submitted

August 13, 2023

First Submitted That Met QC Criteria

August 13, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBGY-202308.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

anonymised patient data are available upon reasonable written request to the authors

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.

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