36 Versus 42 Hour Time Interval From Ovulation to Intraut... | NCT02210611

Studies
36 Versus 42 Hour Time Interval From Ovulation to Intrauterine Insemination

NCT02210611

Sponsor

HaEmek Medical Center, Israel

Status

Terminated

Last Update Posted

Aug 28, 2019Actual

Enrollment

71Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Intrauterine Insemination 36 hours
Intrauterine Insemination 42 hours

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruition too slow

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Apr 29, 2018Actual

Completion Date

Apr 29, 2018Actual

First Submitted Date

Jul 30, 2014

First Submission Date that Met QC Criteria

Aug 6, 2014

First Posted Date

Aug 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2019

Last Update Posted Date

Aug 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
36 hours	Active Comparator	Intrauterine insemination 36 hours after ovulation induction	Procedure: Intrauterine Insemination 36 hours
42 hours	Active Comparator	Intrauterine insemination 42 hours after ovulation induction	Procedure: Intrauterine Insemination 42 hours

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intrauterine Insemination 36 hours	Procedure	Intrauterine insemination 36 hours after ovulation induction	36 hours

Measure	Description	Time Frame
Clinical pregnancy rate		4 weeks following insemination

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

44 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amir Weiss, MD	Haemek Medical Center, Afula, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emek Medical Center		Afula			Israel

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided