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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: Intrauterine Insemination; Drug: Clomiphene; Drug: Letrozole

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Midwest Fertility Specialists- Fort Wayne
    • Indianapolis, Indiana, United States, 46032
      • Midwest Fertility Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per Cycle Pregnancy Rate Based on Infertility Diagnosis		Up to cycle day 35
Pregnancy Rate Per Female Partner Age	Pregnancy rate will be compared between patients <35 and >35 at time of study entry.	Up to cycle day 35
Pregnancy Rate Per Semen Morphology Score	Comparison of pregnancy rate based on semen morphology of <4% vs >4% normal morphology scores.	Up to cycle day 35
Pregnancy Rate Per Body Mass Index Category		Up to cycle day 35

Collaborators and Investigators

• Sponsor: Midwest Fertility Specialists
• Investigators: Principal Investigator: Matthew Will, MD, Midwest Fertility Specialists

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 1, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: November 4, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Infertility; Intrauterine insemination; Luteinizing hormone surge
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Letrozole; Clomiphene
• Other Study ID Numbers: 13-MIDW-101