36 Versus 42 Hour Time Interval From Ovulation to Intrauterine Insemination

NCT ID: NCT02210611

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-04-29

Brief Summary

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The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH antagonists.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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36 hours

Intrauterine insemination 36 hours after ovulation induction

Group Type ACTIVE_COMPARATOR

Intrauterine Insemination 36 hours

Intervention Type PROCEDURE

Intrauterine insemination 36 hours after ovulation induction

42 hours

Intrauterine insemination 42 hours after ovulation induction

Group Type ACTIVE_COMPARATOR

Intrauterine Insemination 42 hours

Intervention Type PROCEDURE

Intrauterine insemination 42 hours after ovulation induction

Interventions

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Intrauterine Insemination 36 hours

Intrauterine insemination 36 hours after ovulation induction

Intervention Type PROCEDURE

Intrauterine Insemination 42 hours

Intrauterine insemination 42 hours after ovulation induction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients who can be monitored for follicle growth and hormone measurements on the day of ovulation trigger, or one day before.
2. Patients who have no more than 4 follicles of 14 mm or more
3. Patients who have no more than 6 follicles of 10 mm or more

Exclusion Criteria

1. Patients who cannot give informed consent to language or comprehension barriers
2. Patients who are deemed to be at high risk for high order multiple gestations
3. Patients who cannot be monitored on the day of hCG administration or one day before
Minimum Eligible Age

17 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amir Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Haemek Medical Center, Afula, Israel

Locations

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Emek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0038-14-EMC

Identifier Type: -

Identifier Source: org_study_id

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