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

NCT ID: NCT02294773

Last Updated: 2015-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Keywords

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Infertility Intrauterine insemination Luteinizing hormone surge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Intrauterine Insemination

Intervention Type 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

Intervention Type DRUG

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

Letrozole

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Intrauterine Insemination

Intervention Type 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

Intervention Type DRUG

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

Letrozole

Intervention Type DRUG

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

Interventions

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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.

Intervention Type PROCEDURE

Clomiphene

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

Intervention Type DRUG

Letrozole

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

Intervention Type DRUG

Other Intervention Names

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clomid

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Midwest Fertility Specialists

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Will, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Fertility Specialists

Locations

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Midwest Fertility Specialists- Fort Wayne

Fort Wayne, Indiana, United States

Site Status

Midwest Fertility Specialists

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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13-MIDW-101

Identifier Type: -

Identifier Source: org_study_id