ObesityPRO-FIVNCT03395067
Multidisciplinary Treatment of Obesity Prior to in Vitro Fertilization: Impact on Global Reproductive Outcomes (PRO-FIV Study)
A study testing Intervention group in people with Obesity and Infertility, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to IVF on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors. This is a randomized controlled trial in obese infertile women before starting an IVF cycle. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Obesity, Infertility
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jan 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Obese infertile patients (body mass index ≥ 30 Kg/m2) prior to an in vitro fertilization cycle
Who cannot join
- Pathological conditions: diabetes type I, Cushing syndrome, premature ovarian failure, uncontrolled thyroidal dysfunction, hepatic and/or renal dysfunction, antiphospholipid syndrome, medical condition that contraindicate ovarian stimulation and/or pregnancy
- Simultaneous practice of another strategy to lose weight
- Physical conditions limiting exercise training
- Patients unable to understand spanish language or to give informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Gemma Casals, 650533367, gcasals@clinic.cat
About this study
Official title: Multidisciplinary Treatment of Obesity Prior to In Vitro Fertilization: Impact on Global Reproductive Outcomes
The aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to IVF on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors.
This is a randomized controlled trial in obese infertile women before starting an IVF cycle. The intervention is based on a structured multidisciplinary program in support groups, which includes diet, physical activity and psychological therapy. IVF will be started immediately after this therapy. Patients included in the control group will start an IVF cycle immediately after the randomization. The results of this study may allow the identification of patients who would benefit from obesity treatment, so as to establish appropriate preventive and therapeutic strategies and to reduce the maternal obesity impact in future generations.
Read the detailed description
The aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to IVF on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors.
This is a randomized controlled trial in obese infertile women (body mass index ≥30 kg/m2) before starting an IVF cycle. In the intervention group, the aim is a weight loss of at least 10% in a 16-week period of treatment based on a multidisciplinary approach and support groups, which includes diet, physical activity and psychological therapy. IVF will be started immediately after this period. Patients included in the control group will start an IVF cycle immediately after the randomization. The results of this study may allow the identification of patients who would benefit from obesity treatment, so as to establish appropriate preventive and therapeutic strategies and to reduce the maternal obesity impact in future generations.
- Conditions
- Obesity, Infertility
- Being tested
- Intervention group
- Keywords
- Obesity, Infertility, In vitro fertilization
- Medical subject headings
- Obesity, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Lifestyle counseling coupled with psychotherapeutical intervention
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Active comparator | Not described Receives: Behavioral: Intervention group |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate of a healthy baby in a non-complicated pregnancy
live birth rate in a pregnancy without major complications: gestational diabetes, hypertensive disorders, preterm delivery, congenital anomalies, stillbirth, neonatal death, shoulder dystocia, maternal venous thromboembolism, fetal growth abnormal outcomes (macrosomia, large for gestational age, intrauterine growth restriction)
Measured: 10 months after starting the IVF treatment
Secondary outcomes (21)
anthropometric parameters: weight (kilograms)
weight change during intervention, measured in kilograms
Measured: 4 months after starting the intervention
anthropometric parameters: body mass index - BMI (kilograms/metro2)
BMI change during intervention, measured as kilograms/metro2
Measured: 4 months after starting the intervention
anthropometric parameters: abdominal circumference (centimeters)
abdominal circumference change during intervention measured in centimeters
Measured: 4 months after starting the intervention
hormonal parameters: antimullerian hormone (AMH)
AMH serum levels before the intervention (intervention group) and before the IVF (2 arms)
Measured: 2 years (simultaneous analysis of all the biological samples)
hormonal parameters: insulin
insulin serum levels before the intervention (intervention group) and before the IVF (2 arms)
Measured: 2 years (simultaneous analysis of all the biological samples)
hormonal parameters: leptin
leptin serum levels before the intervention (intervention group) and before the IVF (2 arms)
Measured: 2 years (simultaneous analysis of all the biological samples)
hormonal parameters: adiponectin
adiponectin serum levels before the intervention (intervention group) and before the IVF (2 arms)
Measured: 2 years (simultaneous analysis of all the biological samples)
hormonal parameters: ghrelin
ghrelin serum levels before the intervention (intervention group) and before the IVF (2 arms)
Measured: 2 years (simultaneous analysis of all the biological samples)
IVF outcomes: cycle cancellation rate
cycle cancellation rate: cancelled cycles/ initiated cycles
Measured: 3 months after starting IVF cycle
IVF outcomes: gonadotropin doses (UI)
total gonadotropin doses used in the IVF stimulation protocol
Measured: 3 months after starting IVF cycle
IVF outcomes: number of oocytes
number of oocytes retrieved
Measured: 3 months after starting IVF cycle
IVF outcomes: number of embryos
total number of embryos obtained in 2 pronuclear stage
Measured: 3 months after starting IVF cycle
IVF outcomes: number of good quality embryos
number of good quality embryos (type A and B) obtained in the cleavage stage
Measured: 3 months after starting IVF cycle
IVF outcomes: clinical pregnancy rate
clinical pregnancy rate: clinical pregnancies/started cycles
Measured: 3 months after starting IVF cycle
IVF outcomes: miscarriage rate
miscarriage rate: miscarriages/clinical pregnancies
Measured: 3 months after starting IVF cycle
fetal ultrasound
fetal ultrasound and Doppler parameters at 28-32 weeks of gestation. All parameters are measured according to the current guidelines and reported as quantitative measurements.
Measured: 26-30 weeks after confirmation of pregnancy
postpartum anthropometric outcomes: maternal abdominal circumference (centimeters)
Maternal abdominal circumference in centimeters 1 month and 12 months after the delivery
Measured: 12 months after the delivery
postpartum anthropometric outcomes: maternal weight (kilograms)
Maternal weight in kilograms 1 month and 12 months after the delivery
Measured: 12 months after the delivery
postpartum anthropometric outcomes: neonatal weight (grams)
neonatal weight in grams 1 month and 12 months after the delivery
Measured: 12 months after the delivery
postpartum anthropometric outcomes: neonatal height (centimeters)
neonatal height in centimeters 1 month and 12 months after the delivery
Measured: 12 months after the delivery
postpartum anthropometric outcomes: neonatal skin fold measurements (millimeters)
neonatal skin fold measurements in millimeters 1 month and 12 months after the delivery
Measured: 12 months after the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start28 Jan 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial including 2 arms: intervention group and control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gemma Casals i Soler, Hospital Clinic of Barcelona
- Investigators
- Gemma Casals, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395067
- Sponsor's protocol ID
- HCB/2017/0730
- Acronym
- PRO-FIV
- Status last verified
- Jan 2018
- First submitted
- 17 Dec 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Treatment of Obesity Prior to In Vitro Fertilization: Impact on Global Reproductive Outcomes
- ClinicalTrials.gov ID
- NCT03395067
- Acronym / sponsor ID
- PRO-FIV / HCB/2017/0730
- Conditions
- Obesity, Infertility
- Keywords
- Obesity, Infertility, In vitro fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 28 Jan 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to IVF on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors.
This is a randomized controlled trial in obese infertile women before starting an IVF cycle. The intervention is based on a structured multidisciplinary program in support groups, which includes diet, physical activity and psychological therapy. IVF will be started immediately after this therapy. Patients included in the control group will start an IVF cycle immediately after the randomization. The results of this study may allow the identification of patients who would benefit from obesity treatment, so as to establish appropriate preventive and therapeutic strategies and to reduce the maternal obesity impact in future generations.
Detailed description
The aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to IVF on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors.
This is a randomized controlled trial in obese infertile women (body mass index ≥30 kg/m2) before starting an IVF cycle. In the intervention group, the aim is a weight loss of at least 10% in a 16-week period of treatment based on a multidisciplinary approach and support groups, which includes diet, physical activity and psychological therapy. IVF will be started immediately after this period. Patients included in the control group will start an IVF cycle immediately after the randomization. The results of this study may allow the identification of patients who would benefit from obesity treatment, so as to establish appropriate preventive and therapeutic strategies and to reduce the maternal obesity impact in future generations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial including 2 arms: intervention group and control group.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Active comparator | Behavioral: Intervention group |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obese infertile patients (body mass index ≥ 30 Kg/m2) prior to an in vitro fertilization cycle
Key exclusion criteria (4 listed)
- Pathological conditions: diabetes type I, Cushing syndrome, premature ovarian failure, uncontrolled thyroidal dysfunction, hepatic and/or renal dysfunction, antiphospholipid syndrome, medical condition that contraindicate ovarian stimulation and/or pregnancy
- Simultaneous practice of another strategy to lose weight
- Physical conditions limiting exercise training
- Patients unable to understand spanish language or to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupLifestyle counseling coupled with psychotherapeutical intervention | Behavioural | Lifestyle counseling |
Primary outcome
live birth rate of a healthy baby in a non-complicated pregnancy
Time frame: 10 months after starting the IVF treatment
live birth rate in a pregnancy without major complications: gestational diabetes, hypertensive disorders, preterm delivery, congenital anomalies, stillbirth, neonatal death, shoulder dystocia, maternal venous thromboembolism, fetal growth abnormal outcomes (macrosomia, large for gestational age, intrauterine growth restriction)
21 secondary outcomes
anthropometric parameters: weight (kilograms)
Time frame: 4 months after starting the intervention
anthropometric parameters: body mass index - BMI (kilograms/metro2)
Time frame: 4 months after starting the intervention
anthropometric parameters: abdominal circumference (centimeters)
Time frame: 4 months after starting the intervention
hormonal parameters: antimullerian hormone (AMH)
Time frame: 2 years (simultaneous analysis of all the biological samples)
hormonal parameters: insulin
Time frame: 2 years (simultaneous analysis of all the biological samples)
hormonal parameters: leptin
Time frame: 2 years (simultaneous analysis of all the biological samples)
hormonal parameters: adiponectin
Time frame: 2 years (simultaneous analysis of all the biological samples)
hormonal parameters: ghrelin
Time frame: 2 years (simultaneous analysis of all the biological samples)
IVF outcomes: cycle cancellation rate
Time frame: 3 months after starting IVF cycle
IVF outcomes: gonadotropin doses (UI)
Time frame: 3 months after starting IVF cycle
IVF outcomes: number of oocytes
Time frame: 3 months after starting IVF cycle
IVF outcomes: number of embryos
Time frame: 3 months after starting IVF cycle
IVF outcomes: number of good quality embryos
Time frame: 3 months after starting IVF cycle
IVF outcomes: clinical pregnancy rate
Time frame: 3 months after starting IVF cycle
IVF outcomes: miscarriage rate
Time frame: 3 months after starting IVF cycle
fetal ultrasound
Time frame: 26-30 weeks after confirmation of pregnancy
postpartum anthropometric outcomes: maternal abdominal circumference (centimeters)
Time frame: 12 months after the delivery
postpartum anthropometric outcomes: maternal weight (kilograms)
Time frame: 12 months after the delivery
postpartum anthropometric outcomes: neonatal weight (grams)
Time frame: 12 months after the delivery
postpartum anthropometric outcomes: neonatal height (centimeters)
Time frame: 12 months after the delivery
postpartum anthropometric outcomes: neonatal skin fold measurements (millimeters)
Time frame: 12 months after the delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma Casals principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Obesity and Infertility, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gemma Casals (0034932275744, gcasals@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate of a healthy baby in a non-complicated pregnancy (time frame: 10 months after starting the IVF treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.