Septum; UterusPLEASURE-1NCT04098289
Preterm Delivery After Septum Resection
An observational study of Septum; Uterus and Infertility, Female, run by Università degli Studi dell'Insubria.
Trial summary
Uterine septum is the most common congenital uterine malformation. It accounts for approximately 35% of all uterine malformations, while the frequency of uterine malformations in the general fertile population is estimated to be between 1% and 4%. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Septum; Uterus, Infertility, Female, Preterm Birth
- What is being tested?
- Hysteroscopic septum resection and In vitro fertilization
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Dec 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
Study population: Women affected by primary infertility who obtained the first ongoing pregnancy with (cases) or without (controls) previous hysteroscopic septum resection, with or without in vitro fertilization.
Who may be able to join
- Female primary infertility
- Singleton pregnancies
Who cannot join
- Female secondary infertility
- Multiple pregnancies
About this study
Official title: Effect of Hysteroscopic Septum Resection on Preterm Birth Rate in Singleton Pregnancies After Primary Infertility Treatment
Uterine septum is the most common congenital uterine malformation. It accounts for approximately 35% of all uterine malformations, while the frequency of uterine malformations in the general fertile population is estimated to be between 1% and 4%.
The presence of a uterine septum is associated with subfertility and a high incidence of obstetric complications, such as spontaneous abortion, 3-fold increase in preterm premature rupture of the membranes (PROM), 6-fold increase in preterm delivery, malpresentation at delivery, caesarean section, and increased perinatal morbidity and mortality.
Read more
Some studies have found that surgical resection of the uterine septum improves pregnancy outcomes and significantly reduces the risk of preterm delivery. Therefore, the risk for a short-term adverse outcome and long-term sequelae due to preterm delivery such as intraventricular hemorrhage, necrotizing enterocolitis, sepsis, patent ductus arteriosus, retinopathy, deafness, chronic lung disease, cerebral palsy, perinatal death, and impaired mental development in women with uterine septum could be lowered by performing a relatively simple and safe hysteroscopic septum resection (HSR).
However, there are two major concerns regarding HSR: cervical incompetence due to excessive dilatation during hysteroscopy and the rare yet serious complication of uterine rupture in subsequent pregnancy or delivery.
Considering these elements, the aim of this study will be to evaluate the rate of preterm delivery in singleton pregnancy comparing primary infertile women who underwent HSR and who did not undergo the same procedure, with our without in vitro fertilization.
- Conditions
- Septum; Uterus, Infertility, Female, Preterm Birth
- Being tested
- Hysteroscopic septum resection, In vitro fertilization
- Keywords
- Hysteroscopy, Metroplasty, Primary infertility, Preterm delivery
- Medical subject headings
- Infertility, Female, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic septum resectionProcedure or surgery
Hysteroscopic septum resection, using a 26 French continuous-flow resectoscope with monopolar energy and electrolyte-free distension medium.
In vitro fertilizationProcedure or surgery
Fertilization of oocytes with the spermatozoa of the partner, after induction of ovulation and capacitation of the sperm, using fertilization in vitro and embryo transfer (FIVET) or intracytoplasmic sperm injection (ICSI).
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopic septum resection without in vitro fertilization | Primary infertile women who underwent hysteroscopic septum resection and obtained the first pregnancy with natural conception (without the use of in vitro fertilization techniques). Receives: Procedure: Hysteroscopic septum resection | |
| Hysteroscopic septum resection with in vitro fertilization | Primary infertile women who underwent hysteroscopic septum resection and obtained the first pregnancy with the use of in vitro fertilization techniques. Receives: Procedure: Hysteroscopic septum resection; Procedure: In vitro fertilization | |
| Natural conception, without hysteroscopic septum resection | Primary infertile women who did not undergo hysteroscopic septum resection and obtained the first pregnancy with natural conception (without in vitro fertilization techniques). | |
| In vitro fertilization, without hysteroscopic septum resection | Primary infertile women who did not undergo hysteroscopic septum resection and obtained the first pregnancy with the use of in vitro fertilization techniques. Receives: Procedure: In vitro fertilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm delivery rate
Percentage of delivery that occurs before the start of the 37th week of pregnancy.
Measured: Through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septum; UterusStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Helena Ban Frangež, M.D., Study director, University of LjubljanaJana Miklavcic, M.D., Principal investigator, University of LjubljanaAntonio Simone Laganà, M.D., Study chair, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098289
- Sponsor's protocol ID
- PLEASURE-1
- Acronym
- PLEASURE-1
- Status last verified
- Apr 2021
- First submitted
- 19 Sep 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hysteroscopic Septum Resection on Preterm Birth Rate in Singleton Pregnancies After Primary Infertility Treatment
- ClinicalTrials.gov ID
- NCT04098289
- Acronym / sponsor ID
- PLEASURE-1 / PLEASURE-1
- Conditions
- Septum; Uterus, Infertility, Female, Preterm Birth
- Keywords
- Hysteroscopy, Metroplasty, Primary infertility, Preterm delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Collaborators
- University of Ljubljana
- Study start
- Jul 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Sep 2019 (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.
Uterine septum is the most common congenital uterine malformation. It accounts for approximately 35% of all uterine malformations, while the frequency of uterine malformations in the general fertile population is estimated to be between 1% and 4%.
The presence of a uterine septum is associated with subfertility and a high incidence of obstetric complications, such as spontaneous abortion, 3-fold increase in preterm premature rupture of the membranes (PROM), 6-fold increase in preterm delivery, malpresentation at delivery, caesarean section, and increased perinatal morbidity and mortality.
Some studies have found that surgical resection of the uterine septum improves pregnancy outcomes and significantly reduces the risk of preterm delivery. Therefore, the risk for a short-term adverse outcome and long-term sequelae due to preterm delivery such as intraventricular hemorrhage, necrotizing enterocolitis, sepsis, patent ductus arteriosus, retinopathy, deafness, chronic lung disease, cerebral palsy, perinatal death, and impaired mental development in women with uterine septum could be lowered by performing a relatively simple and safe hysteroscopic septum resection (HSR).
However, there are two major concerns regarding HSR: cervical incompetence due to excessive dilatation during hysteroscopy and the rare yet serious complication of uterine rupture in subsequent pregnancy or delivery.
Considering these elements, the aim of this study will be to evaluate the rate of preterm delivery in singleton pregnancy comparing primary infertile women who underwent HSR and who did not undergo the same procedure, with our without in vitro fertilization.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopic septum resection without in vitro fertilization | – | Procedure: Hysteroscopic septum resectionPrimary infertile women who underwent hysteroscopic septum resection and obtained the first pregnancy with natural conception (without the use of in vitro fertilization techniques). |
| Hysteroscopic septum resection with in vitro fertilization | – | Procedure: Hysteroscopic septum resection, Procedure: In vitro fertilizationPrimary infertile women who underwent hysteroscopic septum resection and obtained the first pregnancy with the use of in vitro fertilization techniques. |
| Natural conception, without hysteroscopic septum resection | – | –Primary infertile women who did not undergo hysteroscopic septum resection and obtained the first pregnancy with natural conception (without in vitro fertilization techniques). |
| In vitro fertilization, without hysteroscopic septum resection | – | Procedure: In vitro fertilizationPrimary infertile women who did not undergo hysteroscopic septum resection and obtained the first pregnancy with the use of in vitro fertilization techniques. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women affected by primary infertility who obtained the first ongoing pregnancy with (cases) or without (controls) previous hysteroscopic septum resection, with or without in vitro fertilization.
Key inclusion criteria (2 listed)
- Female primary infertility
- Singleton pregnancies
Key exclusion criteria (2 listed)
- Female secondary infertility
- Multiple pregnancies
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 |
|---|---|---|
| Hysteroscopic septum resectionHysteroscopic septum resection, using a 26 French continuous-flow resectoscope with monopolar energy and electrolyte-free distension medium. | Procedure or surgery | Hysteroscopic septum resection with in vitro fertilization, Hysteroscopic septum resection without in vitro fertilization |
| In vitro fertilizationFertilization of oocytes with the spermatozoa of the partner, after induction of ovulation and capacitation of the sperm, using fertilization in vitro and embryo transfer (FIVET) or intracytoplasmic sperm injection (ICSI). | Procedure or surgery | Hysteroscopic septum resection with in vitro fertilization, In vitro fertilization, without hysteroscopic septum resection |
Primary outcome
Preterm delivery rate
Time frame: Through study completion, an average of 5 year
Percentage of delivery that occurs before the start of the 37th week of pregnancy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Helena Ban Frangež, M.D. study director
University of Ljubljana
Jana Miklavcic, M.D. principal investigator
University of Ljubljana
Antonio Simone Laganà, M.D. study chair
Università degli Studi dell'Insubria
Questions about this trial
What is this clinical trial studying?
An observational study of Septum; Uterus and Infertility, Female, run by Università degli Studi dell'Insubria.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm delivery rate (time frame: Through study completion, an average of 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2021.