NCT03435809

Brief Summary

Many infertility and subfertility issues are treated nowadays with intrauterine inseminations. This is a minimally invasive technique that consists in placing sperm into a woman's uterus. Inseminations have only a fair success rate despite advances in technology ( 7 % per cycle). The goal of this study is to find an easy intervention that could help with success rate. Some studies are showing that the use of Pozzi tenaculum forceps might increase rates of pregnancy following intrauterine inseminations. In order to study the impact of this intervention, we are conducting a randomized controlled trial comparing the rate of term live births after IUI between patients who had their treatment done with a pozzi tenaculum forceps and those who had their treatment done without a tenaculum forceps.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 3, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

3.3 years

First QC Date

February 3, 2018

Last Update Submit

February 3, 2021

Conditions

InfertilityInsemination

Outcome Measures

Primary Outcomes (1)

  • Rate of live births

    Live born delivery resulting from an intrauterine insemination cycle

    10 months after positive pregnancy test

Secondary Outcomes (3)

  • Clinical rate of pregnancy (urinary or blood b-hcG)

    At the end of 1 cycle (approximately 28 days)

  • Patients' global satisfaction assessed by questionnaire

    15 minutes after the intervention

  • Pain Level on visual analog scale

    15 minutes after the intervention

Study Arms (2)

Pozzi for intrauterine insemination

ACTIVE COMPARATOR

Treatment done with a pozzi tenaculum forceps

Procedure: Intrauterine insemination

No Pozzi for intrauterine insemination

ACTIVE COMPARATOR

Treatment done without a tenaculum forceps

Procedure: Intrauterine insemination

Interventions

Intrauterine inseminationPROCEDURE

Obligatory use of a Pozzi forceps tenaculum during intrauterine insemination

No Pozzi for intrauterine inseminationPozzi for intrauterine insemination

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Infertility :Defined as no pregnancy after one year of regular unprotected vaginal intercourse
  • Infertility secondary to endometriosis, to a mild to moderate male factor, to an ovulatory dysfunction, an unexplained infertility or any other known medical indication for IUI.
  • Intrauterine insemination with a partner's semen sample or a donor sample
  • First IUI treatment or first treatment since last pregnancy
  • Ovulation induction with letrozole medication
  • Being able to speak and understand French

You may not qualify if:

  • Bilateral tubal occlusion
  • Active pelvic infection
  • \< 1 X 10\^6 mobile sperm on semen analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUL Centre Mère Enfant Soleil - CHU de Quebec

Québec, Quebec, G1V 4G2, Canada

RECRUITING

Related Publications (1)

  • Dufour S, Viau M, Cote M, Lefebvre J, Maheux-Lacroix S, Bergeron ME. Impact of a Pozzi tenaculum forceps use on the success rate of intrauterine insemination (IUI) : protocol for a randomised control trial. BMJ Open. 2021 Mar 18;11(3):e043230. doi: 10.1136/bmjopen-2020-043230.

    PMID: 33737427DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Marie-Eve Bergeron, MD

    CHUL (CHUdeQuebec) - Département d'endocrinologie de la reproduction

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Dufour, PGY3

CONTACT

418-525-4444stephanie.dufour.10@ulaval.ca

Study Design

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

Study Record Dates

First Submitted

February 3, 2018

First Posted

February 19, 2018

Study Start

June 1, 2019

Primary Completion

October 1, 2022

Study Completion

January 1, 2023

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)