Clinical trial NCT02294773: Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit
Official title: Randomized Controlled Trial Evaluating the Timing of Intrauterine Insemination in Relation to the LH Surge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Infertility
Intrauterine insemination
Luteinizing hormone surge
Lead sponsor: Midwest Fertility Specialists
Sponsor class: INDUSTRY
First posted: 2014-11-19
Enrollment: 13
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Pregnancies Achieved Per Menstrual Cycle.
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
measure: Per Cycle Pregnancy Rate Based on Infertility Diagnosis
timeFrame: Up to cycle day 35
measure: Pregnancy Rate Per Female Partner Age
timeFrame: Up to cycle day 35
measure: Pregnancy Rate Per Semen Morphology Score
timeFrame: Up to cycle day 35
measure: Pregnancy Rate Per Body Mass Index Category
timeFrame: Up to cycle day 35
Locations:
city: Fort Wayne
country: United States
facility: Midwest Fertility Specialists- Fort Wayne
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Fertility Specialists
state: Indiana
Study officials:
affiliation: Midwest Fertility Specialists
name: Matthew Will, MD
role: PRINCIPAL_INVESTIGATOR
References: