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Buserelin acetate versus expectant management in the treatment of infertility associated with minimal or mild endometriosis: A randomized clinical trial

  • Author Footnotes
    a From the Centra per lo Studio e la Terapia dell' Endometriosi, Prima Clinica Ostetrica Ginecologica, Università di Milano
    Luigi Fedele
    Footnotes
    a From the Centra per lo Studio e la Terapia dell' Endometriosi, Prima Clinica Ostetrica Ginecologica, Università di Milano
    Affiliations
    Milan and Bergamo, Italy
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  • Author Footnotes
    b Istituto di Ricerche Farmacologiche “Mario Negri,”
    Fabio Parazzini
    Correspondence
    Reprint requests: Fabio Parazzini, Istituto “Mario Negri,” via Eritrea, 62, 20157 Milan, Italy.
    Footnotes
    b Istituto di Ricerche Farmacologiche “Mario Negri,”
    Affiliations
    Milan and Bergamo, Italy
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  • Author Footnotes
    c Divisione di Ostetricia e Ginecologia, Ospedali Civili Bergamo.
    Enrico Radici
    Footnotes
    c Divisione di Ostetricia e Ginecologia, Ospedali Civili Bergamo.
    Affiliations
    Milan and Bergamo, Italy
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  • Author Footnotes
    a From the Centra per lo Studio e la Terapia dell' Endometriosi, Prima Clinica Ostetrica Ginecologica, Università di Milano
    ,
    Author Footnotes
    b Istituto di Ricerche Farmacologiche “Mario Negri,”
    Luca Bocciolone
    Footnotes
    a From the Centra per lo Studio e la Terapia dell' Endometriosi, Prima Clinica Ostetrica Ginecologica, Università di Milano
    b Istituto di Ricerche Farmacologiche “Mario Negri,”
    Affiliations
    Milan and Bergamo, Italy
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  • Author Footnotes
    a From the Centra per lo Studio e la Terapia dell' Endometriosi, Prima Clinica Ostetrica Ginecologica, Università di Milano
    Stefano Bianchi
    Footnotes
    a From the Centra per lo Studio e la Terapia dell' Endometriosi, Prima Clinica Ostetrica Ginecologica, Università di Milano
    Affiliations
    Milan and Bergamo, Italy
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  • Author Footnotes
    b Istituto di Ricerche Farmacologiche “Mario Negri,”
    Cosetta Bianchi
    Footnotes
    b Istituto di Ricerche Farmacologiche “Mario Negri,”
    Affiliations
    Milan and Bergamo, Italy
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  • Author Footnotes
    a From the Centra per lo Studio e la Terapia dell' Endometriosi, Prima Clinica Ostetrica Ginecologica, Università di Milano
    Giovanni Battista Candiani
    Footnotes
    a From the Centra per lo Studio e la Terapia dell' Endometriosi, Prima Clinica Ostetrica Ginecologica, Università di Milano
    Affiliations
    Milan and Bergamo, Italy
    Search for articles by this author
  • Author Footnotes
    a From the Centra per lo Studio e la Terapia dell' Endometriosi, Prima Clinica Ostetrica Ginecologica, Università di Milano
    b Istituto di Ricerche Farmacologiche “Mario Negri,”
    c Divisione di Ostetricia e Ginecologia, Ospedali Civili Bergamo.
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      Objective: We performed a randomized clinical trial to evaluate the efficacy of intranasal 400 µg buserelin three times daily for 6 months versus expectant management in the treatment of infertile women with pelvic endometriosis stage I or II of the revised American Fertility Society classification.
      Study Design: Seventy-one consecutive patients (mean age 32 years) were studied at the First Department of Obstetrics and Gynecology, University of Milan, and the Department of Obstetrics and Gynecology, Ospedali Riuniti, Bergamo, between February 1988 and June 1989. Thirty-five women were randomly allocated to buserelin treatment and 36 to expectant management. The baseline distribution of subjects for age, diseáse stage, and reproductive history was similar in the two groups. All patients were followed regularly; median follow-up was 17 months in the buserelin group and 18 months in the women given expectant management. If pregnancy did not occur within 12 months of randomization, cycles were monitored by ultrasonography and hormone measurements, and when abnormalities were detected clomiphene citrate and human chorionic gonadotropin were administered.
      Results: A total of 17 pregnancies were observed both in the buserelin-treated patients and in the expectant management group. The 1- and 2-year actuarial overall pregnancy rates were similar in the two groups, 30% and 61% in the former and 37% and 61% in the latter group, respectively. Spontaneous abortion occurred in five of the 17 pregnancies in the women treated with buserelin and in one of the 17 in those managed expectantly; this difference was, however, not statistically significant (χ12 adjusted for disease stage and use of clomiphene citrate and human chorionic gonadotropin treatment = 3.01, p = 0.08). No fetal death or stillbirth was observed.
      Conclusions: Our findings suggest that treatment with gonadotropin-releasing hormone agonists is unlikely to have a marked influence on the reproductive outcome of infertile women with minimal or mild endometriosis.

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