NCT02210611

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2018

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3.3 years

First QC Date

July 30, 2014

Last Update Submit

August 25, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    4 weeks following insemination

Study Arms (2)

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

Intrauterine Insemination 36 hoursPROCEDURE

Intrauterine insemination 36 hours after ovulation induction

36 hours
Intrauterine Insemination 42 hoursPROCEDURE

Intrauterine insemination 42 hours after ovulation induction

42 hours

Eligibility Criteria

Age17 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Amir Weiss, MD

    Haemek Medical Center, Afula, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 7, 2014

Study Start

January 1, 2015

Primary Completion

April 29, 2018

Study Completion

April 29, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

IL(1)