Total Motile Sperm Count and Pregnancy Rate From Intraute... | NCT05999591

Studies
Total Motile Sperm Count and Pregnancy Rate From Intrauterine Insemination

NCT05999591

Sponsor

Universitas Padjadjaran

Status

Completed

Last Update Posted

Aug 21, 2023Actual

Enrollment

330Actual

Phase

Not provided

Conditions

Insemination

Interventions

Intrauterine insemination

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2022Actual

Primary Completion Date

Dec 10, 2022Actual

Completion Date

Jan 22, 2023Actual

First Submitted Date

Aug 13, 2023

First Submission Date that Met QC Criteria

Aug 13, 2023

First Posted Date

Aug 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2023

Last Update Posted Date

Aug 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

330Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intrauterine insemination		Patients undergoing intrauterine insemination	Procedure: Intrauterine insemination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intrauterine insemination	Procedure	Transfer of sperm into the fallopian tube through a specialised cannula	Intrauterine insemination

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran		Bandung	West Java	40161	Indonesia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12350496	Result	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.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases