Intrauterine InseminationNCT04169451
IUI With Letrozole Versus in Natural Cycle
A study testing Letrozole in people with Intrauterine Insemination and Unexplained Infertility, run by Peking University Third Hospital at 1 site in China.
Trial summary
Rationale Intrauterine insemination (IUI) is the treatment of first choice for couples with unexplained and mild male factor infertility in many countries, but it is controversial whether ovarian stimulation improves fertility outcomes. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Intrauterine Insemination, Unexplained Infertility
- What is being tested?
- Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 982 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2022to Jun 2026
- Phase
- Interventional
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, a participating couple must meet all of the following criteria:
- Being diagnosed with unexplained or mild male infertility
- At least one sided tubal patency, established according to local protocol
- Normal or mild impairment of semen quality defined as total motile sperm count (TMSC) no less than 5million, based on at least one recent semen analysis
Who cannot join
- A potential participant who meets any of the following criteria will be excluded from study participation:
- Woman with double sided tubal pathology
- Women with irregular cycles, PCOS or other endocrine disorders
- Man with impaired semen quality: total motile sperm count (TMSC) less than 5million
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Shuo Huang, Dr
About this study
Official title: Intrauterine Insemination With Letrozole Versus Intrauterine Insemination in Natural Cycle. A Muticenter Randomized Controlled Trial
Rationale Intrauterine insemination (IUI) is the treatment of first choice for couples with unexplained and mild male factor infertility in many countries, but it is controversial whether ovarian stimulation improves fertility outcomes. In recent retrospectively collected data, we found that in couples with unexplained and mild male factor infertility undergoing IUI, ovarian stimulation with letrozole increased live birth rate as compared to natural cycle IUI without substantially increasing the multiple pregnancy rate. We therefore intend to perform a randomized clinical trial (RCT) on the subject in five reproductive medical centers in different cities in China.
Objective To test the hypothesis that in couples with unexplained or mild male factor infertility scheduled for an IUI program ovarian stimulation with letrozole increases the live birth rate as compared to natural cycle treatment.
Read more
Study design Multicenter randomized controlled trial.
Study population Women diagnosed with unexplained or mild male factor infertility scheduled for treatment with IUI.
Intervention Women will be randomized for ovarian stimulation with letrozole or to natural cycle IUI. In the group allocated to ovarian stimulation, women will receive oral tablets letrozole 5 mg daily from cycle day 3 for 5 days. We will treat the couples for 3 cycles, with a time horizon of 4 months.
Main study parameters/endpoints Primary outcome is live birth resulting from conception within 4 months after randomization. Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy complications, time to pregnancy leading to live birth.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness The strategies compared are already broadly applied in current practice. No additional risks are expected. There is no benefit for participants, but the results may benefit future infertile couples.
- Conditions
- Intrauterine Insemination, Unexplained Infertility
- Being tested
- Letrozole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Women will be randomized to the group with ovarian stimulation with letrozole or the group without stimulation.
| Study group | Role | What they receive |
|---|---|---|
| letrozole group | Experimental | Women will be given IUI treatment with ovarian stimulation with letrozole 5mg/day starting from day 3 of menstrual cycle for 5 days. Receives: Drug: Letrozole |
| natural cycle group | No intervention | Women will be given IUI treatment without ovarian stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
Primary outcome is live birth resulting from conception within 4 months after randomization.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start29 Sep 2022
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine InseminationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 982 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Hebei Medical University, Tianjin Central Hospital of Gynecology Obstetrics, Yunnan1stpeople's hospital
- Responsible party
- Principal investigator, Jie Qiao, Peking University Third Hospital
- Investigators
- Jie Qiao, Study director, Peking Unversity Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169451
- Sponsor's protocol ID
- IUI with/without stimulation
- Status last verified
- Feb 2024
- First submitted
- 17 Nov 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Insemination With Letrozole Versus Intrauterine Insemination in Natural Cycle. A Muticenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04169451
- Acronym / sponsor ID
- IUI with/without stimulation
- Conditions
- Intrauterine Insemination, Unexplained Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 982 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Hebei Medical University, Tianjin Central Hospital of Gynecology Obstetrics, Yunnan1stpeople's hospital
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Nov 2019 (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.
Rationale Intrauterine insemination (IUI) is the treatment of first choice for couples with unexplained and mild male factor infertility in many countries, but it is controversial whether ovarian stimulation improves fertility outcomes. In recent retrospectively collected data, we found that in couples with unexplained and mild male factor infertility undergoing IUI, ovarian stimulation with letrozole increased live birth rate as compared to natural cycle IUI without substantially increasing the multiple pregnancy rate. We therefore intend to perform a randomized clinical trial (RCT) on the subject in five reproductive medical centers in different cities in China.
Objective To test the hypothesis that in couples with unexplained or mild male factor infertility scheduled for an IUI program ovarian stimulation with letrozole increases the live birth rate as compared to natural cycle treatment.
Study design Multicenter randomized controlled trial.
Study population Women diagnosed with unexplained or mild male factor infertility scheduled for treatment with IUI.
Intervention Women will be randomized for ovarian stimulation with letrozole or to natural cycle IUI. In the group allocated to ovarian stimulation, women will receive oral tablets letrozole 5 mg daily from cycle day 3 for 5 days. We will treat the couples for 3 cycles, with a time horizon of 4 months.
Main study parameters/endpoints Primary outcome is live birth resulting from conception within 4 months after randomization. Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy complications, time to pregnancy leading to live birth.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness The strategies compared are already broadly applied in current practice. No additional risks are expected. There is no benefit for participants, but the results may benefit future infertile couples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| letrozole group | Experimental | Drug: LetrozoleWomen will be given IUI treatment with ovarian stimulation with letrozole 5mg/day starting from day 3 of menstrual cycle for 5 days. |
| natural cycle group | No intervention | –Women will be given IUI treatment without ovarian stimulation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, a participating couple must meet all of the following criteria:
- Being diagnosed with unexplained or mild male infertility
- At least one sided tubal patency, established according to local protocol
- Normal or mild impairment of semen quality defined as total motile sperm count (TMSC) no less than 5million, based on at least one recent semen analysis
Key exclusion criteria (4 listed)
- A potential participant who meets any of the following criteria will be excluded from study participation:
- Woman with double sided tubal pathology
- Women with irregular cycles, PCOS or other endocrine disorders
- Man with impaired semen quality: total motile sperm count (TMSC) less than 5million
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 |
|---|---|---|
| LetrozoleWomen will be randomized to the group with ovarian stimulation with letrozole or the group without stimulation. | Drug | letrozole group |
Primary outcome
live birth rate
Time frame: 14 months
Primary outcome is live birth resulting from conception within 4 months after randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Intrauterine Insemination
Recruiting
Interest of Sperm Insemination at 42 Hours Post hCG Compared to 36h in Intrauterine Insemination
Infertility, Intrauterine Insemination (IUI)
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.
Jie Qiao study director
Peking Unversity Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole in people with Intrauterine Insemination and Unexplained Infertility, run by Peking University Third Hospital 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuo Huang (86-13601203410, homelyleaf@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: 14 months). 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 7 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.