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

NCT02294773 | Completed Results

• 1 other identifier: 13-MIDW-101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Infertility

Keywords

Infertility; Intrauterine insemination; Luteinizing hormone surge

Outcome Measures

Primary Outcomes (1)

• Number of Pregnancies Achieved Per Menstrual Cycle.

  Up to 3 months

Other Outcomes (4)

• Per Cycle Pregnancy Rate Based on Infertility Diagnosis

  Up to cycle day 35

• Pregnancy Rate Per Female Partner Age

  Up to cycle day 35

• Pregnancy Rate Per Semen Morphology Score

  Up to cycle day 35

Study Arms (2)

Day Of

ACTIVE COMPARATOR

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; Drug: Clomiphene; Drug: Letrozole

Day After

ACTIVE COMPARATOR

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; Drug: Clomiphene; Drug: Letrozole

Interventions

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.

Day After; Day Of

Clomiphene DRUG

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

Also known as: clomid

Day After; Day Of

Letrozole DRUG

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

Day After; Day Of

Eligibility Criteria

• Age: 21 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Midwest Fertility Specialists: lead

Study Sites (2)

Midwest Fertility Specialists- Fort Wayne

Fort Wayne, Indiana, 46825, United States

Location

Midwest Fertility Specialists

Indianapolis, Indiana, 46032, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Clomiphene; Letrozole

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Matt Will or Dr. Lauren Messinger
• Organization: Midwest Fertility Specialists or St. Vincent Women's Hospital

laurenmessinger@gmail.com

317-415-7528

Study Officials

• Matthew Will, MD

  Midwest Fertility Specialists

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: November 19, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 9, 2015
• Results First Posted: December 9, 2015

Record last verified: 2015-11

Locations

US (2)