ObesityNCT01952795
Effect of Hypocaloric Diet and Exercise in Obese Women Who Are Subjected to IVF Cycle
A study testing Diet and exercise in people with Obesity, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The purpose of this study is to determine the impact of diet and physical exercise program on pregnancy rate and live birth in obese women who undergo an IVF cycle. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Diet and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to Apr 2016
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who want pregnancy.
- Basal FSH levels ≤ 10 IU / l.
- Infertility to justify treatment with IVF/ICSI.
- Being included in a long protocol with GnRH agonist.
- Presence of both ovaries and uterus able to support embryo implantation and pregnancy.
- Body mass index (BMI) ≥ 30 kg/m2 and ≤ 35 kg/m2.
- Absence of pregnancy before starting ovarian stimulation.
- Having given their written consent.
Who cannot join
- Female age ≤ 18 years and ≥ 35 years.
- Severe male factor not permit an IVF-ICSI with ejaculated sample.
- Patients with low ovarian reserve (basal FSH levels ≥ 10 IU / l or lower antral follicle count to 6 follicles in both ovaries).
- HIV seropositivity, HBV or HCV.
- Clinically important disease.
- Having frozen embryos from previous cycles of assisted reproduction.
Show all 13Show fewer
- Unexplained vaginal bleeding.
- Poor response in previous IVF cycles with standard stimulation protocols
- Any contraindication to become pregnant.
- Known allergy to preparations of gonadotropins or its excipients.
- High consumption of alcohol, drugs or psychotropic drugs.
- Concurrent participation in another study.
- Patients who have done previous cycles of IVF / ICSI without success
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the impact of diet and physical exercise program on pregnancy rate and live birth in obese women who undergo an IVF cycle.
Read the detailed description
The objective of this study is showing that obesity significantly affects the in vitro fertilization cycles lowering the reproductive capacity. The study is been performed in Hospital de la Santa Creu i Sant Pau and Fundació Puigvert of Barcelona. Patients recluted are obese women with sterility problems that require in vitro fertilization (IVF) with a body mass index BMI between 30-35. It´s a randomised study in which half of the patients undergo to a 6 weeks program of diet and exercice. We will analyse the response to ovaric stimulation, the results of the egg retrieval (ovocyte number and quality), rates of fecundation, embryo implantation and clinical gestation.
- Conditions
- Obesity
- Being tested
- Diet and exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and exerciseBehavioural
Total caloric intake aimed at maintaining a diet with> 50% of the caloric content in the form of carbohydrates, less than 10% in the form of saturated fats and 20% from monounsaturated / polyunsaturated (if applicable, up to 25% fat monounsaturated), less than 300 mg / day of dietary cholesterol and about 1.0 g of protein / kg ideal body weight / day.
| Study group | Role | What they receive |
|---|---|---|
| Diet and exercise | Active comparator | Total caloric intake aimed at maintaining a diet with> 50% of the caloric content in the form of carbohydrates, less than 10% in the form of saturated fats and 20% from monounsaturated / polyunsaturated (if applicable, up to 25% fat monounsaturated), less than 300 mg / day of dietary cholesterol and about 1.0 g of protein / kg ideal body weight / day. 3 sessions per week on a bicycle ergometer or on a treadmill (according to body fat distribution and other parameters) modifications carried out weekly, with a gradual increase as to exercise until maximal oxygen consumption 60 - 70% would always preceded by heating 5 minutes. Receives: Behavioral: Diet and exercise |
| No intervention | No intervention | Usual diet and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Pregnancy rate by cycle
Measured: 14 days after embryo transfer
Secondary outcomes (7)
Hyperstimulation rate
Number of patients with moderate or severe hyperstimulation
Measured: At luteal phase and first weeks of pregnancy
Fertility rate
Rate of mature oocytes fertilized by conventional IVF or ICSI
Measured: 24 hours post pick up
Mature oocytes
Number of total mature oocytes obtained after stimulation
Measured: Pick up day
Cancellation rate
Stimulated Patients who fail to perform the follicular puncture
Measured: Durinf the stimulation in follicular phase
Good quality embryos
Number of good quality embryos obtained (A and B) by patient
Measured: Day 3 to 5 post pick up
Abortion rate
Number of non evolutive pregnancies during the first trimester
Measured: First trimester of pregnancy
Live birth rate
Amount of patients who finish the treatment with a live newborn
Measured: Between 7 a 9 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionApr 2016
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 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Responsible party
- Sponsor
- Investigators
- Juan José Espinós-Gómez, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952795
- Sponsor's protocol ID
- IIBSP-DHE-2011-42
- Status last verified
- Aug 2017
- First submitted
- 23 Sep 2013
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypocaloric Diet and Exercise in Obese Women Who Are Subjected to IVF Cycle
- ClinicalTrials.gov ID
- NCT01952795
- Acronym / sponsor ID
- IIBSP-DHE-2011-42
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Sep 2013 (estimated)
- 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 purpose of this study is to determine the impact of diet and physical exercise program on pregnancy rate and live birth in obese women who undergo an IVF cycle.
Detailed description
The objective of this study is showing that obesity significantly affects the in vitro fertilization cycles lowering the reproductive capacity. The study is been performed in Hospital de la Santa Creu i Sant Pau and Fundació Puigvert of Barcelona. Patients recluted are obese women with sterility problems that require in vitro fertilization (IVF) with a body mass index BMI between 30-35. It´s a randomised study in which half of the patients undergo to a 6 weeks program of diet and exercice. We will analyse the response to ovaric stimulation, the results of the egg retrieval (ovocyte number and quality), rates of fecundation, embryo implantation and clinical gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet and exercise | Active comparator | Behavioral: Diet and exerciseTotal caloric intake aimed at maintaining a diet with> 50% of the caloric content in the form of carbohydrates, less than 10% in the form of saturated fats and 20% from monounsaturated / polyunsaturated (if applicable, up to 25% fat monounsaturated), less than 300 mg / day of dietary cholesterol and about 1.0 g of protein / kg ideal body weight / day. 3 sessions per week on a bicycle ergometer or on a treadmill (according to body fat distribution and other parameters) modifications carried out weekly, with a gradual increase as to exercise until maximal oxygen consumption 60 - 70% would always preceded by heating 5 minutes. |
| No intervention | No intervention | –Usual diet and exercise |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women who want pregnancy.
- Basal FSH levels ≤ 10 IU / l.
- Infertility to justify treatment with IVF/ICSI.
- Being included in a long protocol with GnRH agonist.
- Presence of both ovaries and uterus able to support embryo implantation and pregnancy.
Key exclusion criteria (13 listed)
- Female age ≤ 18 years and ≥ 35 years.
- Severe male factor not permit an IVF-ICSI with ejaculated sample.
- Patients with low ovarian reserve (basal FSH levels ≥ 10 IU / l or lower antral follicle count to 6 follicles in both ovaries).
- HIV seropositivity, HBV or HCV.
- Clinically important disease.
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 |
|---|---|---|
| Diet and exerciseTotal caloric intake aimed at maintaining a diet with> 50% of the caloric content in the form of carbohydrates, less than 10% in the form of saturated fats and 20% from monounsaturated / polyunsaturated (if applicable, up to 25% fat monounsaturated), less than 300 mg / day of dietary cholesterol and about 1.0 g of protein / kg ideal body weight / day. | Behavioural | Diet and exercise |
Primary outcome
Pregnancy rate
Time frame: 14 days after embryo transfer
Pregnancy rate by cycle
7 secondary outcomes
Hyperstimulation rate
Time frame: At luteal phase and first weeks of pregnancy
Fertility rate
Time frame: 24 hours post pick up
Mature oocytes
Time frame: Pick up day
Cancellation rate
Time frame: Durinf the stimulation in follicular phase
Good quality embryos
Time frame: Day 3 to 5 post pick up
Abortion rate
Time frame: First trimester of pregnancy
Live birth rate
Time frame: Between 7 a 9 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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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.
Juan José Espinós-Gómez, MD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and exercise in people with Obesity, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 8 inclusion and 13 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: finished, as of the sponsor's last update on 22 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: 14 days after embryo transfer). 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 22 Aug 2017.