Status:
COMPLETED
Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit
Lead Sponsor:
Midwest Fertility Specialists
Conditions:
Infertility
Eligibility:
FEMALE
21-39 years
Phase:
NA
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 kit...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02294773
Start Date
October 1 2013
End Date
September 1 2015
Last Update
December 9 2015
Active Locations (2)
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1
Midwest Fertility Specialists- Fort Wayne
Fort Wayne, Indiana, United States, 46825
2
Midwest Fertility Specialists
Indianapolis, Indiana, United States, 46032