InseminationNCT05999591
Total Motile Sperm Count and Pregnancy Rate From Intrauterine Insemination
An observational study of Insemination, run by Universitas Padjadjaran at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Insemination
- What is being tested?
- Intrauterine insemination
- Type of treatment
- Surgery or procedure
- How many people
- 330 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Nov 2022to 22 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: A group of patients undergoing intrauterine insemination for various causes of infertility at a tertiary fertility clinic
Who may be able to join
- post-wash total motile sperm count needed to be over 5 x 10^5
Who cannot join
- missing data on pregnancy outcome and missing medical records
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran
Bandung, West Java, 40161
About this study
Official title: 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.
- Conditions
- Insemination
- Being tested
- Intrauterine insemination
- Keywords
- infertility, intrauterine insemination, post-wash total motile sperm count
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine inseminationProcedure or surgery
Transfer of sperm into the fallopian tube through a specialised cannula
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine insemination | Patients undergoing intrauterine insemination Receives: Procedure: Intrauterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Pregnancy number divided by number of IUI cycles
Measured: max 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start30 Nov 2022
- Primary completion10 Dec 2022
- Study completion22 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InseminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanom H Syam, M.D., Ph.D, Principal investigator, Department of Obstetrics and Gynecology, Faculty of Medicine Universitas Padjadjaran Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999591
- Sponsor's protocol ID
- OBGY-202308.01
- Status last verified
- Aug 2023
- First submitted
- 13 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: anonymised patient data are available upon reasonable written request to the authors
Publications
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.
PubMed 12350496
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Post-Wash Total Motile Sperm Count on the Pregnancy Rate of Infertility Patients Undergoing Intrauterine Insemination
- ClinicalTrials.gov ID
- NCT05999591
- Acronym / sponsor ID
- OBGY-202308.01
- Conditions
- Insemination
- Keywords
- infertility, intrauterine insemination, post-wash total motile sperm count
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 22 Jan 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrauterine insemination | – | Procedure: Intrauterine inseminationPatients undergoing intrauterine insemination |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A group of patients undergoing intrauterine insemination for various causes of infertility at a tertiary fertility clinic
Key inclusion criteria (1 listed)
- post-wash total motile sperm count needed to be over 5 x 10^5
Key exclusion criteria (1 listed)
- missing data on pregnancy outcome and missing medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrauterine inseminationTransfer of sperm into the fallopian tube through a specialised cannula | Procedure or surgery | Intrauterine insemination |
Primary outcome
Pregnancy rate
Time frame: max 9 months
Pregnancy number divided by number of IUI cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Results publication: PubMed 12350496Miller 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.
- Individual participant dataSharing planned: No. anonymised patient data are available upon reasonable written request to the authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanom H Syam, M.D., Ph.D principal investigator
Department of Obstetrics and Gynecology, Faculty of Medicine Universitas Padjadjaran Bandung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insemination, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: max 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05999591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.