Pozzi Forceps in Intrauterine Insemination
Primary Purpose
Infertility, Insemination
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intrauterine insemination
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility 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
- First IUI treatment or first treatment since last pregnancy
- Ovulation induction with letrozole medication
- Being able to speak and understand French
Exclusion Criteria:
- Bilateral tubal occlusion
- Active pelvic infection
- < 1 X 10^6 mobile sperm on semen analysis
Sites / Locations
- CHUL Centre Mère Enfant Soleil - CHU de QuebecRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pozzi for intrauterine insemination
No Pozzi for intrauterine insemination
Arm Description
Treatment done with a pozzi tenaculum forceps
Treatment done without a tenaculum forceps
Outcomes
Primary Outcome Measures
Rate of live births
Live born delivery resulting from an intrauterine insemination cycle
Secondary Outcome Measures
Clinical rate of pregnancy (urinary or blood b-hcG)
Positive urinary pregnancy test ou blood test (b-hcG)
Patients' global satisfaction assessed by questionnaire
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?
Pain Level on visual analog scale
Measure from 0-100 in mm, 100 being the highest pain level On a scale from 0-10 with intermediate values, 10 being the worst pain ever and 0 being no pain at all.
Full Information
NCT ID
NCT03435809
First Posted
February 3, 2018
Last Updated
February 3, 2021
Sponsor
CHU de Quebec-Universite Laval
1. Study Identification
Unique Protocol Identification Number
NCT03435809
Brief Title
Pozzi Forceps in Intrauterine Insemination
Official Title
Randomized Control Study on the Impact of a Pozzi Tenaculum Forceps Use on the Success Rate of Intrauterine Insemination (IUI)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Once the initial investigations are done, an oral treatment is started on the first cycle if medically indicated.
At mid-cycle, patients undergo a transvaginal ultrasound looking for follicles' maturation. This ultrasound's goal is to detect ovulation and plan the IUI. If no follicle is detected, the transvaginal ultrasound is repeated later. If there is no luteinizing hormone (LH) peak detected upon ovulation urine test, there will be an ovulation induction with human chorionic gonadotropin (hCG) based depending on patient's age, number and size of detected follicles. Subcutaneous hCG or intramuscular hCG can be used. A cycle can be cancelled if there is no ovulation or if there is ovarian hyperstimulation.
During ovulation, semen analysis is performed, looking at sperm volume, sperm concentration and mobility. Then, semen is treated with a density gradient or with centrifugation. Isolated sperm are diluted in 0.5 to 1 mL of media and maintained in an incubator at a 37 º C temperature until insemination. The laboratory performs a second analysis on the washed semen in order to obtain the most accurate measures. If donor's semen is used, the andrology laboratory prepares the specimen and then processes with the semen analysis.
Patients are inseminated the day after a spontaneous LH peak or 24-36h after ovulation induction. For those who are randomized to the intervention group, a pozzi tenaculum forceps will be applied and clamped horizontally to the anterior cervical labrum with only a single click and mild traction will be applied in another to decrease the uterocervical angle. When no tenaculum is applied, motion will be mimicked without actual tissue prehension. Patients randomized to the control group will only have a tenaculum forceps applied in cases where the IUI is not feasible otherwise by the gynecologist. Indeed, it is sometimes necessary, when the cervical anatomy does not allow for easy pass of the catheter, for a pozzi tenaculum forceps to be used in order to insert the insemination catheter properly in the uterine cavity. In that case, tenaculum use will be recorded in the patient's file. No cervical insemination is allowed. Insemination is performed with flexible catheters and care is taken to avoid touching the uterine fundus with the catheter tip. There are multiple catheters available in the gynecology clinic, namely catheters The Curve (Cooper Surgical, Berlin), Shapeable IUI Catheter (Thomas Medical, Indianapolis) and Mini space (Laboratory C.C.D., Paris). After the intervention, patients are instructed to lie flat for 10 minutes after which they go home until next appointment.
Intercourse is allowed following IUI treatments. Patients are instructed to perform a urinary pregnancy test at home to weeks after the IUI, which will be provided to them. If the test is positive, patients are scheduled for a transvaginal ultrasound on week #7 of amenorrhea to confirm proper intrauterine pregnancy evolution. When pregnancy is confirmed, patients are referred to an physician for obstetrical follow-up.
In case of treatment failure, patients go on with ovulation induction or stimulation for the next cycle as previously prescribed by the gynecologist at mid-cycle ultrasound, if indicated. Dosages of ovarian stimulation medication may be modified, at physician's discretion, in order to optimize response to treatment according to the usual indications (ovarian hyperstimulation, side effects, poor response, etc.) Patients will be followed for 3 cycles and, if need be, can receive subsequent IUI treatments outside research protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Insemination
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pozzi for intrauterine insemination
Arm Type
Active Comparator
Arm Description
Treatment done with a pozzi tenaculum forceps
Arm Title
No Pozzi for intrauterine insemination
Arm Type
Active Comparator
Arm Description
Treatment done without a tenaculum forceps
Intervention Type
Procedure
Intervention Name(s)
Intrauterine insemination
Intervention Description
Obligatory use of a Pozzi forceps tenaculum during intrauterine insemination
Primary Outcome Measure Information:
Title
Rate of live births
Description
Live born delivery resulting from an intrauterine insemination cycle
Time Frame
10 months after positive pregnancy test
Secondary Outcome Measure Information:
Title
Clinical rate of pregnancy (urinary or blood b-hcG)
Description
Positive urinary pregnancy test ou blood test (b-hcG)
Time Frame
At the end of 1 cycle (approximately 28 days)
Title
Patients' global satisfaction assessed by questionnaire
Description
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?
Time Frame
15 minutes after the intervention
Title
Pain Level on visual analog scale
Description
Measure from 0-100 in mm, 100 being the highest pain level On a scale from 0-10 with intermediate values, 10 being the worst pain ever and 0 being no pain at all.
Time Frame
15 minutes after the intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
First IUI treatment or first treatment since last pregnancy
Ovulation induction with letrozole medication
Being able to speak and understand French
Exclusion Criteria:
Bilateral tubal occlusion
Active pelvic infection
< 1 X 10^6 mobile sperm on semen analysis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Dufour, PGY3
Phone
418-525-4444
Email
stephanie.dufour.10@ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Eve Bergeron, MD
Organizational Affiliation
CHUL (CHUdeQuebec) - Département d'endocrinologie de la reproduction
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUL Centre Mère Enfant Soleil - CHU de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Ève Bergeron, MD
Phone
418-525-4444
Ext
42777
Email
meb@mebergeron.com
First Name & Middle Initial & Last Name & Degree
Stephanie Dufour, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33737427
Citation
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.
Results Reference
derived
Learn more about this trial
Pozzi Forceps in Intrauterine Insemination
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