InfertilityNCT03435809
Pozzi Forceps in Intrauterine Insemination
A study testing Intrauterine insemination in people with Infertility and Insemination, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Insemination
- What is being tested?
- Intrauterine insemination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2019to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Bilateral tubal occlusion
- Active pelvic infection
- < 1 X 10^6 mobile sperm on semen analysis
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHUL Centre Mère Enfant Soleil - CHU de Quebec
Québec, Quebec, G1V 4G2
Marie-Ève Bergeron, MD, 418-525-4444 ext. 42777, meb@mebergeron.com
Stephanie Dufour, MD
About this study
Official title: Randomized Control Study on the Impact of a Pozzi Tenaculum Forceps Use on the Success Rate of Intrauterine Insemination (IUI)
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.
Read the 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.
- Conditions
- Infertility, Insemination
- Being tested
- Intrauterine insemination
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine inseminationProcedure or surgery
Obligatory use of a Pozzi forceps tenaculum during intrauterine insemination
| Study group | Role | What they receive |
|---|---|---|
| Pozzi for intrauterine insemination | Active comparator | Treatment done with a pozzi tenaculum forceps Receives: Procedure: Intrauterine insemination |
| No Pozzi for intrauterine insemination | Active comparator | Treatment done without a tenaculum forceps Receives: Procedure: Intrauterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of live births
Live born delivery resulting from an intrauterine insemination cycle
Measured: 10 months after positive pregnancy test
Secondary outcomes (3)
Clinical rate of pregnancy (urinary or blood b-hcG)
Positive urinary pregnancy test ou blood test (b-hcG)
Measured: At the end of 1 cycle (approximately 28 days)
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?
Measured: 15 minutes after the intervention
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.
Measured: 15 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Jun 2019
- Primary completionOct 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Eve Bergeron, MD, Principal investigator, CHUL (CHUdeQuebec) - Département d'endocrinologie de la reproduction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435809
- Sponsor's protocol ID
- CHUdeQuebec
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2018
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33737427
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study on the Impact of a Pozzi Tenaculum Forceps Use on the Success Rate of Intrauterine Insemination (IUI)
- ClinicalTrials.gov ID
- NCT03435809
- Acronym / sponsor ID
- CHUdeQuebec
- Conditions
- Infertility, Insemination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pozzi for intrauterine insemination | Active comparator | Procedure: Intrauterine inseminationTreatment done with a pozzi tenaculum forceps |
| No Pozzi for intrauterine insemination | Active comparator | Procedure: Intrauterine inseminationTreatment done without a tenaculum forceps |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Bilateral tubal occlusion
- Active pelvic infection
- < 1 X 10^6 mobile sperm on semen analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrauterine inseminationObligatory use of a Pozzi forceps tenaculum during intrauterine insemination | Procedure or surgery | No Pozzi for intrauterine insemination, Pozzi for intrauterine insemination |
Primary outcome
Rate of live births
Time frame: 10 months after positive pregnancy test
Live born delivery resulting from an intrauterine insemination cycle
3 secondary outcomes
Clinical rate of pregnancy (urinary or blood b-hcG)
Time frame: At the end of 1 cycle (approximately 28 days)
Patients' global satisfaction assessed by questionnaire
Time frame: 15 minutes after the intervention
Pain Level on visual analog scale
Time frame: 15 minutes after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Derived from this study: PubMed 33737427Dufour 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Eve Bergeron, MD principal investigator
CHUL (CHUdeQuebec) - Département d'endocrinologie de la reproduction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine insemination in people with Infertility and Insemination, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Dufour, PGY3 (418-525-4444, stephanie.dufour.10@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of live births (time frame: 10 months after positive pregnancy test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03435809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.