It is hypothesed 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…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Pregnancy, labour, delivery and postpartum conditions
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of healthy children, born after at least 37 weeks of gestation
during the 3 years follow-up period.
Secondary outcome
* percentage effective weight loss.
* comorbity related to bariatric surgery.
* metabolic and endocrinological changes.
* maternal, perinatal and neonatal complications.
* comorbiditty related to morbid obesity.
* quality of life.
Background summary
Obesity is an epidemic causing metabolic comorbidity (i.e. diabetes type 2,
hypertension, dyslipidemia) and mortality. Besides that, obesity leads to
subfertility in women due to polycystic ovarian syndrome (PCOS). Furthermore,
it increases miscarriage rates and complications during pregnancy and delivery,
which as a result lead to an increase in maternal and neonatal morbidity and
mortality. If these obese women seek medical care for subfertility attention
focusses on the achievement of pregnancy and the consequences of metabolic
syndrome (MS) can be overlooked.
Study objective
It is hypothesed 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.
Study design
This study will be a multicenter prospective randomized controlled trial
comparing conventional lifestyle intervention with bariatric surgery for
subfertile obese women (BMI of 35 kg/m2 or more) with PCOS.
Intervention: bariatric surgery. Control: Life style intervention program.Power
analysis (including drop outs) indicates 120 patients in both the intervention
and the control group. Follow-up on an out-patient basis for 3 years.
Intervention
Bariatric surgery: Laparoscopic Roux-en-Y Gastric Bypass. Operative procedures
will be performed by, or under direct supervision of a bariatric surgeon with
an experience of at least 200 bariatric operations.
Study burden and risks
Risks:
Risks related to (bariatric) surgery and anaesthesia.
Extra burden for the patient:
1) Questionnaires at the intake of the study and at the follow-up visits
(baseline, 6 weeks, 3, 6, 12, 24 and 36 months). The time needed to complete
the questionnaires is approximately 30 minutes per visit.
2) Extra venous blood samples (ca. 50 ml) will be taken at the time of the
follow-up visits.
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
• Age 18-40 years
• BMI of 35 kg/m2 or more.
• Subfertile women with PCOS
• No previous fertility treatment.
• Informed consent and willing to enter the follow up program.
Exclusion criteria
• Azoospermia, severe endometriosis, WHO class III anovulation (premature
ovarian
failure).
• Prior fertility treatment.
• Prior bariatric surgery.
• Prior major abdominal surgery
• ASA classification >= IV
• Severe concomitant disease.
• The inability to understand written information..
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47257.078.15 |