Reproductive IssuesNCT07344623
Factors Associated With Clinical Pregnancy Outcomes in Intrauterine Insemination (IUI) Cycles
An observational study of Reproductive Issues, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Hypotheses: We hypothesize that variations in hormonal profiles (LH, estradiol, progesterone) during ovarian stimulation, follicular response, endometrial characteristics, and sperm quality parameters are significantly associated with clinical pregnancy outcomes in intrauterine insemination (IUI) cycles. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Reproductive Issues
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2026to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: This retrospective study will include all infertile couples who underwent intrauterine insemination (IUI) at the Asisted Reproductive Unit, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Hong Kong, China
Who may be able to join
- Couples who underwent at least one IUI-intrauterine insemination cycle.
Who cannot join
- Couples who used donor sperm.
- Cases with missing core outcome data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Chung PW Jacqueline, 35053489, jacquelinechung@cuhk.edu.hk
About this study
Hypotheses:
We hypothesize that variations in hormonal profiles (LH, estradiol, progesterone) during ovarian stimulation, follicular response, endometrial characteristics, and sperm quality parameters are significantly associated with clinical pregnancy outcomes in intrauterine insemination (IUI) cycles.
Read more
Aims
- To investigate the association between hormonal profiles on the trigger day (LH, estradiol, progesterone), follicular response, endometrial thickness, and sperm parameters with clinical pregnancy outcomes in IUI cycles.
- To develop and validate a predictive model for clinical pregnancy incorporating key determinants such as female age, hormonal response, endometrial characteristics, and sperm quality.
- To compare natural and gonadotropin-stimulated IUI cycles in terms of hormonal profiles, pregnancy outcomes, and cost-effectiveness.
Primary Outcome Clinical pregnancy rate (CPR), defined as the presence of a gestational sac with a fetal heartbeat on ultrasound at approximately 6 weeks of gestation following intrauterine insemination.
Secondary Outcomes
- Biochemical pregnancy rate.
- Ongoing pregnancy rate
- Live birth rate
Read the detailed description
Statistical Analysis
Each sub-study will employ specific analytical approaches:
- Univariate and multivariate logistic regression for associations
- Mediation and interaction analysis
- ROC and AUC analysis for predictive modeling
- Machine learning for model development
- Cost-effectiveness evaluated via incremental cost per clinical pregnancy
Consent
This is a retrospective study, and thus, there is no need for a written informed consent.
Sample Size All eligible IUI cycles, estimated to be approximately 3000 cycles, will be included
- Conditions
- Reproductive Issues
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate (CPR)
Rate of clinical pregnancy outcome in subjects undergoing IUI
Measured: 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI.
Secondary outcomes (3)
Biochemical pregnancy rate
Rate of biochemical pregnancy outcome in subjects undergoing IUI
Measured: Up to 12 weeks
Ongoing pregnancy rate
Rate of Ongoing pregnancy outcome in subjects undergoing IUI
Measured: Up to 12 weeks
live birth rate
Rate of live birth rate outcome in subjects undergoing IUI
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start13 Jan 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive IssuesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Pui Wah Jacqueline, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344623
- Sponsor's protocol ID
- 2025.831
- Status last verified
- May 2026
- First submitted
- 30 Dec 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Clinical Pregnancy Outcomes in Intrauterine Insemination (IUI) Cycles
- ClinicalTrials.gov ID
- NCT07344623
- Acronym / sponsor ID
- 2025.831
- Conditions
- Reproductive Issues
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 15 Jan 2026 (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.
Hypotheses:
We hypothesize that variations in hormonal profiles (LH, estradiol, progesterone) during ovarian stimulation, follicular response, endometrial characteristics, and sperm quality parameters are significantly associated with clinical pregnancy outcomes in intrauterine insemination (IUI) cycles.
Aims
- To investigate the association between hormonal profiles on the trigger day (LH, estradiol, progesterone), follicular response, endometrial thickness, and sperm parameters with clinical pregnancy outcomes in IUI cycles.
- To develop and validate a predictive model for clinical pregnancy incorporating key determinants such as female age, hormonal response, endometrial characteristics, and sperm quality.
- To compare natural and gonadotropin-stimulated IUI cycles in terms of hormonal profiles, pregnancy outcomes, and cost-effectiveness.
Primary Outcome Clinical pregnancy rate (CPR), defined as the presence of a gestational sac with a fetal heartbeat on ultrasound at approximately 6 weeks of gestation following intrauterine insemination.
Secondary Outcomes
- Biochemical pregnancy rate.
- Ongoing pregnancy rate
- Live birth rate
Detailed description
Statistical Analysis
Each sub-study will employ specific analytical approaches:
- Univariate and multivariate logistic regression for associations
- Mediation and interaction analysis
- ROC and AUC analysis for predictive modeling
- Machine learning for model development
- Cost-effectiveness evaluated via incremental cost per clinical pregnancy
Consent
This is a retrospective study, and thus, there is no need for a written informed consent.
Sample Size All eligible IUI cycles, estimated to be approximately 3000 cycles, will be included
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This retrospective study will include all infertile couples who underwent intrauterine insemination (IUI) at the Asisted Reproductive Unit, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Hong Kong, China
Key inclusion criteria (1 listed)
- Couples who underwent at least one IUI-intrauterine insemination cycle.
Key exclusion criteria (2 listed)
- Couples who used donor sperm.
- Cases with missing core outcome data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical pregnancy rate (CPR)
Time frame: 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI.
Rate of clinical pregnancy outcome in subjects undergoing IUI
3 secondary outcomes
Biochemical pregnancy rate
Time frame: Up to 12 weeks
Ongoing pregnancy rate
Time frame: Up to 12 weeks
live birth rate
Time frame: Up to 40 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Reproductive Issues, run by Chinese University of Hong Kong at 1 site in China.
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 2 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (CPR) (time frame: 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.