InfertilityNCT02210611
36 Versus 42 Hour Time Interval From Ovulation to Intrauterine Insemination
A study testing Intrauterine Insemination 36 hours and Intrauterine Insemination 42 hours in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH antagonists. Read more about this study
- Who is it for?
- Ages 17 to 44 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Intrauterine Insemination 36 hours and Intrauterine Insemination 42 hours
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to 29 Apr 2018
- 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 17 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who can be monitored for follicle growth and hormone measurements on the day of ovulation trigger, or one day before.
- Patients who have no more than 4 follicles of 14 mm or more
- Patients who have no more than 6 follicles of 10 mm or more
Who cannot join
- Patients who cannot give informed consent to language or comprehension barriers
- Patients who are deemed to be at high risk for high order multiple gestations
- Patients who cannot be monitored on the day of hCG administration or one day before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 36 Versus 42 Hour Time Interval From Ovulation Induction to Intrauterine Insemination in Stimulated Cycles With GnRH Antagonists
The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH antagonists.
- Conditions
- Infertility
- Being tested
- Intrauterine Insemination 36 hours, Intrauterine Insemination 42 hours
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine Insemination 36 hoursProcedure or surgery
Intrauterine insemination 36 hours after ovulation induction
Intrauterine Insemination 42 hoursProcedure or surgery
Intrauterine insemination 42 hours after ovulation induction
| Study group | Role | What they receive |
|---|---|---|
| 36 hours | Active comparator | Intrauterine insemination 36 hours after ovulation induction Receives: Procedure: Intrauterine Insemination 36 hours |
| 42 hours | Active comparator | Intrauterine insemination 42 hours after ovulation induction Receives: Procedure: Intrauterine Insemination 42 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 4 weeks following insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJan 2015
- Primary completion29 Apr 2018
- Study completion29 Apr 2018
Why it stopped: Recruition too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amir Weiss, MD, Principal investigator, Haemek Medical Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210611
- Sponsor's protocol ID
- 0038-14-EMC
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2014
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 36 Versus 42 Hour Time Interval From Ovulation Induction to Intrauterine Insemination in Stimulated Cycles With GnRH Antagonists
- ClinicalTrials.gov ID
- NCT02210611
- Acronym / sponsor ID
- 0038-14-EMC
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruition too slow
- Enrolment
- 71 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 29 Apr 2018 (actual)
- Study completion
- 29 Apr 2018 (actual)
- First posted
- 7 Aug 2014 (estimated)
- 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.
The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH antagonists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 36 hours | Active comparator | Procedure: Intrauterine Insemination 36 hoursIntrauterine insemination 36 hours after ovulation induction |
| 42 hours | Active comparator | Procedure: Intrauterine Insemination 42 hoursIntrauterine insemination 42 hours after ovulation induction |
Who may qualify
- Ages
- 17 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients who can be monitored for follicle growth and hormone measurements on the day of ovulation trigger, or one day before.
- Patients who have no more than 4 follicles of 14 mm or more
- Patients who have no more than 6 follicles of 10 mm or more
Key exclusion criteria (3 listed)
- Patients who cannot give informed consent to language or comprehension barriers
- Patients who are deemed to be at high risk for high order multiple gestations
- Patients who cannot be monitored on the day of hCG administration or one day before
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 Insemination 36 hoursIntrauterine insemination 36 hours after ovulation induction | Procedure or surgery | 36 hours |
| Intrauterine Insemination 42 hoursIntrauterine insemination 42 hours after ovulation induction | Procedure or surgery | 42 hours |
Primary outcome
Clinical pregnancy rate
Time frame: 4 weeks following insemination
Results and safety
The study was stopped early (reason given: Recruition too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
Amir Weiss, MD principal investigator
Haemek Medical Center, Afula, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine Insemination 36 hours and Intrauterine Insemination 42 hours in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Aug 2019. 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 Israel. 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 was stopped early (reason given: Recruition too slow). Results are not available in the source record.
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?
Clinical pregnancy rate (time frame: 4 weeks following insemination). 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 28 Aug 2019.