Preterm Delivery After Septum Resection

NCT ID: NCT04098289

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 420 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2019-12-31

Brief 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%.

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.

Conditions

Septum; Uterus; Infertility, Female; Preterm Birth

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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).

Hysteroscopic septum resection

Intervention Type: PROCEDURE

Hysteroscopic septum resection, using a 26 French continuous-flow resectoscope with monopolar energy and electrolyte-free distension medium.

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.

Hysteroscopic septum resection

Intervention Type: PROCEDURE

Hysteroscopic septum resection, using a 26 French continuous-flow resectoscope with monopolar energy and electrolyte-free distension medium.

In vitro fertilization

Intervention Type: PROCEDURE

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).

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).

No interventions assigned to this group

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.

In vitro fertilization

Intervention Type: PROCEDURE

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).

Interventions

Hysteroscopic septum resection

Hysteroscopic septum resection, using a 26 French continuous-flow resectoscope with monopolar energy and electrolyte-free distension medium.

Intervention Type: PROCEDURE

In vitro fertilization

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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Female primary infertility
• Singleton pregnancies

Exclusion Criteria

• Female secondary infertility
• Multiple pregnancies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana

OTHER

Sponsor Role: collaborator

Università degli Studi dell'Insubria

OTHER

Sponsor Role: lead

Responsible Party

Antonio Simone Laganà

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helena Ban Frangež, M.D.

Role: STUDY_DIRECTOR

University of Ljubljana

Jana Miklavcic, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Ljubljana

Antonio Simone Laganà, M.D.

Role: STUDY_CHAIR

Università degli Studi dell'Insubria

Other Identifiers

PLEASURE-1

Identifier Type: -

Identifier Source: org_study_id