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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294773
• Other study ID #: 13-MIDW-101
• Status: Completed
• Phase: N/A
• First received: October 1, 2014
• Last updated: November 4, 2015
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Midwest Fertility Specialists
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
United States	Midwest Fertility Specialists- Fort Wayne	Fort Wayne	Indiana
United States	Midwest Fertility Specialists	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Midwest Fertility Specialists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Per Cycle Pregnancy Rate Based on Infertility Diagnosis		Up to cycle day 35	No
Other	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	No
Other	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	No
Other	Pregnancy Rate Per Body Mass Index Category		Up to cycle day 35	No
Primary	Number of Pregnancies Achieved Per Menstrual Cycle.		Up to 3 months	No