Preterm Delivery After Septum Resection (PLEASURE-1)

Università degli Studi dell'Insubria

Status: Completed

Conditions: Septum; Uterus; Infertility, Female; Preterm Birth

Treatments: Procedure: In vitro fertilization; Procedure: Hysteroscopic septum resection

Study type: Observational

Funder types: Other

Identifiers

NCT04098289

PLEASURE-1

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female primary infertility
• Singleton pregnancies

Exclusion criteria

• Female secondary infertility
• Multiple pregnancies

Trial design

420 participants in 4 patient groups

Hysteroscopic septum resection without in vitro fertilization

Description:

Primary infertile women who underwent hysteroscopic septum resection and obtained the first pregnancy with natural conception (without the use of in vitro fertilization techniques).

Treatment:

Procedure: Hysteroscopic septum resection

Hysteroscopic septum resection with in vitro fertilization

Description:

Primary infertile women who underwent hysteroscopic septum resection and obtained the first pregnancy with the use of in vitro fertilization techniques.

Treatment:

Procedure: In vitro fertilization

Procedure: Hysteroscopic septum resection

Natural conception, without hysteroscopic septum resection

Description:

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

Description:

Primary infertile women who did not undergo hysteroscopic septum resection and obtained the first pregnancy with the use of in vitro fertilization techniques.

Treatment:

Procedure: In vitro fertilization