Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrauterine Insemination | Procedure | Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pregnancies Achieved Per Menstrual Cycle. | Up to 3 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Per Cycle Pregnancy Rate Based on Infertility Diagnosis | Up to cycle day 35 | |
| Pregnancy Rate Per Female Partner Age | Pregnancy rate will be compared between patients <35 and >35 at time of study entry. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew Will, MD | Midwest Fertility Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Fertility Specialists- Fort Wayne | Fort Wayne | Indiana | 46825 | United States | ||
| Midwest Fertility Specialists |
Not provided
Patients recruited from two clinical offices from 1/2014 until 9/2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Insemination Day Of Positive OPK | 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. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7. |
| FG001 | Insemination Day After Positive OPK | 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. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Insemination Day Of Positive OPK | 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. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Pregnancies Achieved Per Menstrual Cycle. | Posted | Number | pregnancies per cycle | Up to 3 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insemination Day Of Positive OPK | 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. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matt Will or Dr. Lauren Messinger | Midwest Fertility Specialists or St. Vincent Women's Hospital | 317-415-7528 | laurenmessinger@gmail.com |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002996 | Clomiphene |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clomiphene | Drug | Patient is to take clomiphene citrate during cycle days 3-7. |
|
|
| Letrozole | Drug | Patient is to take letrozole during cycle days 3-7. |
|
| Up to cycle day 35 |
| Pregnancy Rate Per Semen Morphology Score | Comparison of pregnancy rate based on semen morphology of <4% vs >4% normal morphology scores. | Up to cycle day 35 |
| Pregnancy Rate Per Body Mass Index Category | Up to cycle day 35 |
| Indianapolis |
| Indiana |
| 46032 |
| United States |
| BG001 | Insemination Day After Positive OPK | 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. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Day 3 Follicle Stimulating Hormone | Mean | Standard Deviation | mIU/ml |
|
| Anti-mullerian Hormone | Mean | Standard Deviation | ng/ml |
|
| Sperm Concentration | Mean | Standard Deviation | million sperm/ml |
|
| Sperm morphology | Mean | Standard Deviation | Percent normal |
|
| Mid-luteal progesterone | Mean | Standard Deviation | ng/ml |
|
|
|
| Other Pre-specified | Per Cycle Pregnancy Rate Based on Infertility Diagnosis | Posted | Number | pregnancies per cycle | Up to cycle day 35 |
|
|
|
| Other Pre-specified | Pregnancy Rate Per Female Partner Age | Pregnancy rate will be compared between patients <35 and >35 at time of study entry. | Posted | Number | pregnancies per cycle | Up to cycle day 35 |
|
|
|
| Other Pre-specified | Pregnancy Rate Per Semen Morphology Score | Comparison of pregnancy rate based on semen morphology of <4% vs >4% normal morphology scores. | Posted | Number | pregnancies per cycle | Up to cycle day 35 |
|
|
|
| Other Pre-specified | Pregnancy Rate Per Body Mass Index Category | Posted | Number | pregnancies per cycle | Up to cycle day 35 |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Insemination Day After Positive OPK | 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. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7. | 0 | 6 | 0 | 6 |
Not provided
Not provided
Not provided
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Body mass index obese |
|