Preterm Delivery After Septum Resection

NCT04098289 | Completed DMC

• 1 other identifier: PLEASURE-1
• Study Type: observational
• Target: 420
• Locations: 0 countries
• Sites: N/A

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

Keywords

Hysteroscopy; Metroplasty; Primary infertility; Preterm delivery

Outcome Measures

Primary Outcomes (1)

• Preterm delivery rate

  Percentage of delivery that occurs before the start of the 37th week of pregnancy.

  Through study completion, an average of 5 year

Study Arms (4)

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).

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.

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.

Procedure: In vitro fertilization

Interventions

Hysteroscopic septum resection 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; Hysteroscopic septum resection without in vitro fertilization

In vitro fertilization 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).

Hysteroscopic septum resection with in vitro fertilization; In vitro fertilization, without hysteroscopic septum resection

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Female primary infertility
• Singleton pregnancies

You may not qualify if:

• Female secondary infertility
• Multiple pregnancies

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead
• University of Ljubljana: collaborator

MeSH Terms

Conditions

Infertility, Female; Premature Birth

Interventions

Fertilization in Vitro

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Helena Ban Frangež, M.D.

  University of Ljubljana

  STUDY DIRECTOR

• Jana Miklavcic, M.D.

  University of Ljubljana

  PRINCIPAL INVESTIGATOR

• Antonio Simone Laganà, M.D.

  Università degli Studi dell'Insubria

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2019
• Last Updated: April 29, 2021

Record last verified: 2021-04