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Pozzi Forceps in Intrauterine Insemination

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ClinicalTrials.gov Identifier: NCT03435809
Recruitment Status : Not yet recruiting
First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

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.

Condition or disease Intervention/treatment Phase
Infertility Insemination Procedure: Intrauterine insemination Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Control Study on the Impact of a Pozzi Tenaculum Forceps Use on the Success Rate of Intrauterine Insemination (IUI)
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: Pozzi for intrauterine insemination
Treatment done with a pozzi tenaculum forceps
Procedure: Intrauterine insemination
Obligatory use of a Pozzi forceps tenaculum during intrauterine insemination

Active Comparator: No Pozzi for intrauterine insemination
Treatment done without a tenaculum forceps
Procedure: Intrauterine insemination
Obligatory use of a Pozzi forceps tenaculum during intrauterine insemination




Primary Outcome Measures :
  1. Rate of live births [ Time Frame: At the end of 1 cycle (approximately 28 days) ]
    Term delivery resulting from an intrauterine insemination cycle


Secondary Outcome Measures :
  1. Clinical rate of pregnancy [ Time Frame: At the end of 1 cycle (approximately 28 days) ]
    Positive urinary pregnancy test ou blood test (b-hcG)

  2. Patients' global satisfaction [ Time Frame: 15 minutes after the intervention ]
    In regards of the treatment they received, yes/no questions Are you satisfied with the treatment you received? Do you think this treatment is an reasonable option of treatment?

  3. Pain [ Time Frame: 15 minutes after the intervention ]
    Visual analog scale (http://www.sfetd-douleur.org/sites/default/files/u3349/evaluation/eva_image.pdf) On a scale from 0-10 with intermediate values, 10 being the worst pain ever and 0 being no pain at all.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • Ovulation induction with letrozole medication
  • Being able to speak and understand French

Exclusion Criteria:

  • Bilateral tubal occlusion
  • Active pelvic infection
  • <1X10^6 mobile sperm on semen analysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435809


Contacts
Contact: Stephanie Dufour, PGY2 438-883-3150 stephanie.dufour.10@ulaval.ca

Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
Principal Investigator: Marie-Eve Bergeron, MD Marie-Ève Bergeron MD FRCSC, Gynecologist and reproductive endocrinology and infertility specialist, CHUL (CHUdeQuebec)

Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT03435809     History of Changes
Other Study ID Numbers: CHUdeQuebec
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female