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PLEASURE-1
Effect of Hysteroscopic Septum Resection on Preterm Birth Rate in Singleton Pregnancies After Primary Infertility Treatment
Sponsor study identifier
observational
420
0 countries
N/A
Study Start
July 2012
Actual (reported)Primary Completion
December 2015
Actual (reported)Study Completion
December 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2012
Actual (reported)December 2015
Actual (reported)September 19, 2019
Actual (reported)September 23, 2019
Actual (reported)December 2019
Actual (reported)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
Primary infertile women who underwent hysteroscopic septum resection and obtained the first pregnancy with natural conception (without the use of in vitro fertilization techniques).
Primary infertile women who underwent hysteroscopic septum resection and obtained the first pregnancy with the use of in vitro fertilization techniques.
Primary infertile women who did not undergo hysteroscopic septum resection and obtained the first pregnancy with natural conception (without in vitro fertilization techniques).
Primary infertile women who did not undergo hysteroscopic septum resection and obtained the first pregnancy with the use of in vitro fertilization techniques.
Hysteroscopic septum resection, using a 26 French continuous-flow resectoscope with monopolar energy and electrolyte-free distension medium.
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).
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.
Helena Ban Frangež, M.D.
University of Ljubljana
Jana Miklavcic, M.D.
University of Ljubljana
Antonio Simone Laganà, M.D.
Università degli Studi dell'Insubria
420 participants (actual enrollment reported by the registry).
First Submitted
September 19, 2019
First Posted
September 23, 2019
Study Start
July 2012
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2015
Actual (reported)Study Completion
December 2019
Actual (reported)Last Updated
April 29, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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