Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - 39 |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | September 2015 |
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.
(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.
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.
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)
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