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Completed

NCT Number: NCT02294773

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

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.

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Key information

Age range

21 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Midwest Fertility Specialists- Fort Wayne, Fort Wayne, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Clomiphene

Drug

Patient is to take clomiphene citrate during cycle days 3-7.

Other names: clomid

letrozole

Drug

Patient is to take letrozole during cycle days 3-7.

Primary outcomes

  1. Number of Pregnancies Achieved Per Menstrual Cycle.

    Time frame: Up to 3 months

Other outcomes

  1. Per Cycle Pregnancy Rate Based on Infertility Diagnosis

    Time frame: Up to cycle day 35

  2. Pregnancy Rate Per Female Partner Age

    Time frame: Up to cycle day 35

    Pregnancy rate will be compared between patients <35 and >35 at time of study entry.

  3. Pregnancy Rate Per Semen Morphology Score

    Time frame: Up to cycle day 35

    Comparison of pregnancy rate based on semen morphology of <4% vs >4% normal morphology scores.

  4. Pregnancy Rate Per Body Mass Index Category

    Time frame: Up to cycle day 35

Sponsors and collaborators

Lead sponsor

Midwest Fertility Specialists

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 19, 2014
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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