Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial Evaluating the Timing of Intrauterine Insemination in Relation to the LH Surge

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Intrauterine Insemination
* Drug: Clomiphene
* Drug: Letrozole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Day Of<br>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. | Procedure: Intrauterine Insemination<br>* Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.<br>Drug: Clomiphene<br>* Patient is to take clomiphene citrate during cycle days 3-7.<br>* Other names: clomid;Drug: Letrozole<br>* Patient is to take letrozole during cycle days 3-7.<br>|
| Active Comparator: Day After<br>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. | Procedure: Intrauterine Insemination<br>* Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.<br>Drug: Clomiphene<br>* Patient is to take clomiphene citrate during cycle days 3-7.<br>* Other names: clomid;Drug: Letrozole<br>* Patient is to take letrozole during cycle days 3-7.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pregnancies Achieved Per Menstrual Cycle. |  | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Intrauterine insemination, Luteinizing hormone surge