The null hypothesis implies that intervention (bariatric surgery) compared with control (life style intervention program) will increase fertility measured by the healthy born baby rate after at least 37 weeks of gestation (primary end point) within…
ID
Bron
Aandoening
Subfertility
PCOS
Morbid obesity
Bariatric surgery
Life style modification
Ondersteuning
Erasmus Medical Center
Department of Department of Reproductive Endocrinology
3000 CA Rotterdam, The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint is the rate of healthy born baby rate after at least 37 weeks of gestation (primary end point) within three years after therapy.
Achtergrond van het onderzoek
RESEARCH QUESTION: To assess the effectiveness of bariatric surgery versus life style modification in morbidly obese subfertile women with PCOS.
HYPOTHESIS: Bariatric surgery is superior to life style modification in achieving pregnancy.
STUDY DESIGN: Randomized controlled multicenter clinical trial.
STUDY POPULATION: Subfertile PCOS patients with a BMI > 35 kg/m2.
INTERVENTION: Bariatric surgery.
USUAL CARE/COMPARISON: Life style modification.
OUTCOME MEASURES: Primary outcome measure: life born, at term, children within the 3 years follow-up period. Secondary outcome measures: effective weight loss; comorbidity related to bariatric surgery; metabolic and endocrinologic changes; maternal, perinatal and neonatal complications; comorbidity related to morbid obesity; quality of life.
SAMPLE SIZE / DATA ANALYSIS: 120 patients in both arms, based on a difference of 20% in effectiveness between both treatment options. Data analysis according to the intention to treat principle.
Doel van het onderzoek
The null hypothesis implies that intervention (bariatric surgery) compared with control (life style intervention program) will increase fertility measured by the healthy born baby rate after at least 37 weeks of gestation (primary end point) within 3 years following therapy.
Onderzoeksopzet
Conventional fertility treatment in the investigational group will start 12 months after surgery.
Conventional fertility treatment in the control group will start 12 months after the commencement of the twelve-month lifestyle program and / or after achieving the target weight reduction of at least 5%
Follow-up will be performed in an out-patient clinical setting at 6 weeks, 3 months, 6 and 12 months and then every year for 3 years
Onderzoeksproduct en/of interventie
Bariatric surgery, Laparoscopic gastric bypass
Publiek
Sint Franciscus Gasthuis<br>
Kleiweg 500
R.M.F. Weiden, van der
Rotterdam 3045 PM
The Netherlands
+31 (0)10 4616161
r.vanderweiden@sfg.nl
Wetenschappelijk
Sint Franciscus Gasthuis<br>
Kleiweg 500
R.M.F. Weiden, van der
Rotterdam 3045 PM
The Netherlands
+31 (0)10 4616161
r.vanderweiden@sfg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Age 18-40 years
• BMI > 35 kg/m2.
• Subfertile women with PCOS according to the Rotterdam criteria.
• No previous fertility treatment.
• Psychological screening.
• Informed consent and willingness to participate in the follow up program.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Azoospermia, endometriosis AFS class > III, WHO class III anovulation (premature ovarian failure) or endocrinopathies (such as Cushing syndrome, adrenal hyperplasia and diabetes type I).
• Pregnancy induced hypertension, preeclampsia, eclampsia or HELPP syndrome in a previous pregnancy.
• Prior fertility treatment.
• Prior bariatric surgery.
• Prior major abdominal surgery (like colonic resection, septic abdomen, aorta surgery, which might jeopardise the possibility of execution a LSG or LRYGB)
• ASA (American Society for Anesthesiologists) classification ≥ IV
• Alcohol or drug abuse
• Severe concomitant disease (carcinomas, neurodegenerative disorders or other disorders presently representing being considered exclusion criteria for bariatric surgery )
• The inability to understand written information, necessary to give informed consent and to complete questionnaires.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7196 |
| NTR-old | NTR7395 |
| Ander register | METC Erasmus MC : MEC-2015-123 / NL 47257.078.15 |