InfertilityNCT02294773
Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit
A study testing Intrauterine Insemination, Clomiphene and Letrozole in people with Infertility, run by Midwest Fertility Specialists at 2 sites in United States.
Trial summary
The aim of this study is to assess the impact of the timing of intrauterine insemination (IUI) in relation to the natural surge of luteinizing hormone (LH), as detected by home ovulation predictor kits, on pregnancy rates per treatment cycle. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Intrauterine Insemination, Clomiphene and Letrozole
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All couples consisting of male and female partner undergoing CC or letrozole cycle plus IUI at a single infertility center (Midwest Fertility Specialists)
- The female partner must be aged 21-39
- Infertile couples include those with a diagnosis(s) of unexplained infertility, mild male factor, ovulatory dysfunction, or anovulation
- Evidence of a normal uterus and at least unilateral tubal patency on saline infusion sonogram or hysterosalpingogram within the last 2 years
- Semen analysis for male partner must have minimal sperm concentration of 10 million per milliliter
Who cannot join
- Recurrent miscarriages
- Nursing mothers
- Diagnoses of primary ovarian failure, diminishing ovarian reserve (as indicated by blood follicle stimulating hormone >10 milliInternationalUnits/mL and/or anti-mullerian hormone level <0.5), abnormal uterine bleeding of undetermined origin, ovarian cyst of undetermined origin, stage IV endometriosis, or sex-hormone dependent tumors
- Documented bilateral tubal obstruction or other uncorrected uterine anomalies (e.g. uterine septum)
- Previous gonadotropin use and/or previous treatment with in vitro fertilization
- Abnormal semen analysis (sperm concentration less than 10 million per mL) or ejaculatory dysfunction in male partner
- Other uncorrected medical condition in female partner that would be a contraindication to attempting elective ovulation induction (e.g., uncontrolled diabetes, intracranial lesion, thyroid or adrenal disease)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Midwest Fertility Specialists- Fort Wayne
Fort Wayne, Indiana, 46825
Midwest Fertility Specialists
Indianapolis, Indiana, 46032
About this study
Official title: Randomized Controlled Trial Evaluating the Timing of Intrauterine Insemination in Relation to the LH Surge
The aim of this study is to assess the impact of the timing of intrauterine insemination (IUI) in relation to the natural surge of luteinizing hormone (LH), as detected by home ovulation predictor kits, on pregnancy rates per treatment cycle. The study will take place at the offices of Midwest Fertility Specialists and include patients who have been independently recommended by their primary physician to undergo ovulation induction with clomiphene citrate (CC) or letrozole and IUI as therapy for infertility.
Read the detailed description
Intrauterine insemination is a procedure that is performed in the physician's office. During the procedure the sperm from the male partner are placed directly into the female partner's uterus around the time of ovulation (release of oocyte or egg). Ovulation predictor kits, available over the counter at pharmacies, test for the presence of luteinizing hormone in the urine. When the test result is a positive, it means the hormone is present in the urine. This is a sign of ovulation. Physicians typically choose to perform intrauterine insemination either the day of a positive ovulation test or the day after a positive ovulation test. The purpose of this study is to determine if the day when intrauterine insemination is performed influences the chance of becoming pregnant.
- Conditions
- Infertility
- Being tested
- Intrauterine Insemination, Clomiphene, Letrozole
- Keywords
- Infertility, Intrauterine insemination, Luteinizing hormone surge
- 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
Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
ClomipheneDrug
Also called clomid
Patient is to take clomiphene citrate during cycle days 3-7.
LetrozoleDrug
Patient is to take letrozole during cycle days 3-7.
| Study group | Role | What they receive |
|---|---|---|
| Day Of | Active comparator | This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive. Receives: Procedure: Intrauterine Insemination; Drug: Clomiphene; Drug: Letrozole |
| Day After | Active comparator | This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive. Receives: Procedure: Intrauterine Insemination; Drug: Clomiphene; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Pregnancies Achieved Per Menstrual Cycle.
Measured: Up to 3 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 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Fertility Specialists
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Will, MD, Principal investigator, Midwest Fertility Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294773
- Sponsor's protocol ID
- 13-MIDW-101
- Status last verified
- Nov 2015
- First submitted
- 1 Oct 2014
- Last updated
- 9 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating the Timing of Intrauterine Insemination in Relation to the LH Surge
- ClinicalTrials.gov ID
- NCT02294773
- Acronym / sponsor ID
- 13-MIDW-101
- Conditions
- Infertility
- Keywords
- Infertility, Intrauterine insemination, Luteinizing hormone surge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Midwest Fertility SpecialistsIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Posted 9 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the impact of the timing of intrauterine insemination (IUI) in relation to the natural surge of luteinizing hormone (LH), as detected by home ovulation predictor kits, on pregnancy rates per treatment cycle. The study will take place at the offices of Midwest Fertility Specialists and include patients who have been independently recommended by their primary physician to undergo ovulation induction with clomiphene citrate (CC) or letrozole and IUI as therapy for infertility.
Detailed description
Intrauterine insemination is a procedure that is performed in the physician's office. During the procedure the sperm from the male partner are placed directly into the female partner's uterus around the time of ovulation (release of oocyte or egg). Ovulation predictor kits, available over the counter at pharmacies, test for the presence of luteinizing hormone in the urine. When the test result is a positive, it means the hormone is present in the urine. This is a sign of ovulation. Physicians typically choose to perform intrauterine insemination either the day of a positive ovulation test or the day after a positive ovulation test. The purpose of this study is to determine if the day when intrauterine insemination is performed influences the chance of becoming pregnant.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day Of | Active comparator | Procedure: Intrauterine Insemination, Drug: Clomiphene, Drug: LetrozoleThis group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive. |
| Day After | Active comparator | Procedure: Intrauterine Insemination, Drug: Clomiphene, Drug: LetrozoleThis group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive. |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All couples consisting of male and female partner undergoing CC or letrozole cycle plus IUI at a single infertility center (Midwest Fertility Specialists)
- The female partner must be aged 21-39
- Infertile couples include those with a diagnosis(s) of unexplained infertility, mild male factor, ovulatory dysfunction, or anovulation
- Evidence of a normal uterus and at least unilateral tubal patency on saline infusion sonogram or hysterosalpingogram within the last 2 years
- Semen analysis for male partner must have minimal sperm concentration of 10 million per milliliter
Key exclusion criteria (7 listed)
- Recurrent miscarriages
- Nursing mothers
- Diagnoses of primary ovarian failure, diminishing ovarian reserve (as indicated by blood follicle stimulating hormone >10 milliInternationalUnits/mL and/or anti-mullerian hormone level <0.5), abnormal uterine bleeding of undetermined origin, ovarian cyst of undetermined origin, stage IV endometriosis, or sex-hormone dependent tumors
- Documented bilateral tubal obstruction or other uncorrected uterine anomalies (e.g. uterine septum)
- Previous gonadotropin use and/or previous treatment with in vitro fertilization
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 InseminationIntrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. | Procedure or surgery | Day After, Day Of |
| ClomipheneAlso: clomidPatient is to take clomiphene citrate during cycle days 3-7. | Drug | Day After, Day Of |
| LetrozolePatient is to take letrozole during cycle days 3-7. | Drug | Day After, Day Of |
Primary outcome
Number of Pregnancies Achieved Per Menstrual Cycle.
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Matthew Will, MD principal investigator
Midwest Fertility Specialists
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine Insemination, Clomiphene and Letrozole in people with Infertility, run by Midwest Fertility Specialists at 2 sites in United States.
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 5 inclusion and 7 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 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Pregnancies Achieved Per Menstrual Cycle. (time frame: Up to 3 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 9 Dec 2015.