InfertilityNCT01566929
Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)
A study testing Low calorie diet treatment in people with Infertility and Obesity, run by Sahlgrenska University Hospital at 9 sites in 3 countries.
Trial summary
The primary aim of the study is to evaluate if weight management intervention for obese women (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating woman, as compared to women where no intervention was made. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility, Obesity
- What is being tested?
- Low calorie diet treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Oct 2010to Apr 2018
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Indication for IVF/ICSI for the couple
- Woman's age >18< 38 years at randomization
- First, second or third IVF/ICSI treatment
- BMI > or = 30.0 <35.0 kg/m2
- Willing to participate and to sign informed consent
Who cannot join
- Diabetes mellitus treated with insulin
- Oocyte or sperm donation planned
- Preimplantation genetic diagnosis (PGD) treatment planned
- Azoospermia known at randomization
- Patient not having adequate knowledge of Swedish (to understand patient information and questionnaires)
- QEWP-R questionnaire indicating binge eating disorder for the woman
- Previous participation in the study
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Denmark4 sites
Herlev hospital
Copenhagen
Hvidovre hospital
Copenhagen
Rigshospitalet
Copenhagen
Holbaek hospital
Holbæk
Sweden4 sites
Sahlgrenska University Hospital
Gothenburg
Skånes Universitetssjukhus
Malmö
Örebro University Hospital
Örebro
Karolinska Universitetssjukhuset
Stockholm
About this study
Official title: Weight Management Interventions for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF): a Randomized Controlled Trial
The primary aim of the study is to evaluate if weight management intervention for obese women (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating woman, as compared to women where no intervention was made.
Read the detailed description
- There will be two groups of patients.
- The first group (n=167) will receive weight management intervention during up to four months prior to IVF treatment.The group randomized to intervention will start an intensive weight reduction plan. The aim of the weight reduction is to reach as close to normal BMI (<25.0 kg/m2) as possible during a time of approximately 4 months. The purpose of the dietary intervention is to create a negative energy balance to induce weight loss. The intervention starts with 12 weeks of a low calorie liquid formula diet (LCD) and thereafter, diet re-introduction and weight control stabilization until IVF treatment begins. Should the patient for some reason be unable to fulfil the LCD-treatment, she will anyhow have an individualized dietary counselling to help her loose weight until the time for her IVF-treatment.
- The second group (n=167) will start their IVF-treatment directly without other intervention than written advice about the benefits of weight reduction and exercise. The group randomized directly to IVF-treatment will start the treatment as soon as possible after randomization, preferably within that menstrual cycle.
- Tertiary aim is a follow-up 2 years after randomization to the study with questionnaires to the couple in both the intervention and the control groups. A special questionnaire will cover the weights of the couple and if the woman has had any pregnancies or live births after concluding the study. For the women having achieved a live birth in the index-cycle of IVF the number of children and also follow-up of the children will be performed by assessing medical records from pediatric clinic (if applicable) and child health care centres covering birth data, general health and weight of the children at birth and at the assessment date. Eating -habits and -patterns and quality of life parameters will be assessed with the same three questionnaires that were filled in after randomization.
- Conditions
- Infertility, Obesity
- Being tested
- Low calorie diet treatment
- Keywords
- Obesity, In vitro fertilization, Low calorie diet (LCD), Obstetric outcome, Weight reduction
- Medical subject headings
- Infertility, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low calorie diet treatmentDietary supplement
Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| IVF only | No intervention | IVFtreatment |
| Weight reduction treatment and IVF | Active comparator | Dietary Supplement: Low calorie diet treatment and then IVFtreatment Receives: Dietary Supplement: Low calorie diet treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Live birth per participating woman
Measured: Approximately 10-16 months after randomization, depending on study group.
Secondary outcomes (4)
embryology
number of good quality embryos
Measured: After theIVF-treatment, approximately 1-6 months after randomization
obstetric outcomes
obstetric and neonatal data
Measured: Approximately 10-16 months after randomization, after delivery
compliance to intervention
Compliance to intervention assessed as weight loss during intervention, dietary intake and quality of life
Measured: Assessed in the intervention group 12-16 weeks after randomization, prior to IVF-treatment
Husband data
Measurement of the husband for height, weight and dietary intake and eating patterns correlated to sperm count, sperm motility and sperm chromatin fragmentation
Measured: before IVF-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startOct 2010
- Primary completionJan 2016
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Outcomes assessor
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Skane University Hospital, Region Örebro County, Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Herlev Hospital, Holbaek Sygehus, ART Medica clinic, Iceland
- Responsible party
- Principal investigator, Ann Thurin Kjellberg, Sahlgrenska University Hospital
- Investigators
- Ann Thurin Kjellberg, MD PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566929
- Sponsor's protocol ID
- Obesity/IVF
- Status last verified
- Sep 2018
- First submitted
- 23 Mar 2012
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Svensson H, Einarsson S, Olausson D, Kluge L, Bergh C, Eden S, Lonn M, Thurin-Kjellberg A. Inflammatory and metabolic markers in relation to outcome of in vitro fertilization in a cohort of predominantly overweight and obese women. Sci Rep. 2022 Aug 3;12(1):13331. doi: 10.1038/s41598-022-17612-2.
PubMed 35922472Kluge L, Bergh C, Einarsson S, Pinborg A, Mikkelsen Englund AL, Thurin-Kjellberg A. Cumulative live birth rates after weight reduction in obese women scheduled for IVF: follow-up of a randomized controlled trial. Hum Reprod Open. 2019 Dec 10;2019(4):hoz030. doi: 10.1093/hropen/hoz030. eCollection 2019.
PubMed 31844684Einarsson S, Bergh C, Friberg B, Pinborg A, Klajnbard A, Karlstrom PO, Kluge L, Larsson I, Loft A, Mikkelsen-Englund AL, Stenlof K, Wistrand A, Thurin-Kjellberg A. Weight reduction intervention for obese infertile women prior to IVF: a randomized controlled trial. Hum Reprod. 2017 Aug 1;32(8):1621-1630. doi: 10.1093/humrep/dex235.
PubMed 28854592
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Management Interventions for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01566929
- Acronym / sponsor ID
- Obesity/IVF
- Conditions
- Infertility, Obesity
- Keywords
- Obesity, In vitro fertilization, Low calorie diet (LCD), Obstetric outcome, Weight reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Skane University Hospital, Region Örebro County, Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Herlev Hospital, Holbaek Sygehus, ART Medica clinic, Iceland
- Study start
- Oct 2010 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 30 Mar 2012 (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 primary aim of the study is to evaluate if weight management intervention for obese women (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating woman, as compared to women where no intervention was made.
Detailed description
- There will be two groups of patients.
- The first group (n=167) will receive weight management intervention during up to four months prior to IVF treatment.The group randomized to intervention will start an intensive weight reduction plan. The aim of the weight reduction is to reach as close to normal BMI (<25.0 kg/m2) as possible during a time of approximately 4 months. The purpose of the dietary intervention is to create a negative energy balance to induce weight loss. The intervention starts with 12 weeks of a low calorie liquid formula diet (LCD) and thereafter, diet re-introduction and weight control stabilization until IVF treatment begins. Should the patient for some reason be unable to fulfil the LCD-treatment, she will anyhow have an individualized dietary counselling to help her loose weight until the time for her IVF-treatment.
- The second group (n=167) will start their IVF-treatment directly without other intervention than written advice about the benefits of weight reduction and exercise. The group randomized directly to IVF-treatment will start the treatment as soon as possible after randomization, preferably within that menstrual cycle.
- Tertiary aim is a follow-up 2 years after randomization to the study with questionnaires to the couple in both the intervention and the control groups. A special questionnaire will cover the weights of the couple and if the woman has had any pregnancies or live births after concluding the study. For the women having achieved a live birth in the index-cycle of IVF the number of children and also follow-up of the children will be performed by assessing medical records from pediatric clinic (if applicable) and child health care centres covering birth data, general health and weight of the children at birth and at the assessment date. Eating -habits and -patterns and quality of life parameters will be assessed with the same three questionnaires that were filled in after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF only | No intervention | –IVFtreatment |
| Weight reduction treatment and IVF | Active comparator | Dietary Supplement: Low calorie diet treatmentDietary Supplement: Low calorie diet treatment and then IVFtreatment |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Indication for IVF/ICSI for the couple
- Woman's age >18< 38 years at randomization
- First, second or third IVF/ICSI treatment
- BMI > or = 30.0 <35.0 kg/m2
- Willing to participate and to sign informed consent
Key exclusion criteria (7 listed)
- Diabetes mellitus treated with insulin
- Oocyte or sperm donation planned
- Preimplantation genetic diagnosis (PGD) treatment planned
- Azoospermia known at randomization
- Patient not having adequate knowledge of Swedish (to understand patient information and questionnaires)
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 |
|---|---|---|
| Low calorie diet treatmentReduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks | Dietary supplement | Weight reduction treatment and IVF |
Primary outcome
Live birth
Time frame: Approximately 10-16 months after randomization, depending on study group.
Live birth per participating woman
4 secondary outcomes
embryology
Time frame: After theIVF-treatment, approximately 1-6 months after randomization
obstetric outcomes
Time frame: Approximately 10-16 months after randomization, after delivery
compliance to intervention
Time frame: Assessed in the intervention group 12-16 weeks after randomization, prior to IVF-treatment
Husband data
Time frame: before IVF-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 7 Sep 2018.
- Derived from this study: PubMed 35922472Svensson H, Einarsson S, Olausson D, Kluge L, Bergh C, Eden S, Lonn M, Thurin-Kjellberg A. Inflammatory and metabolic markers in relation to outcome of in vitro fertilization in a cohort of predominantly overweight and obese women. Sci Rep. 2022 Aug 3;12(1):13331. doi: 10.1038/s41598-022-17612-2.
- Derived from this study: PubMed 31844684Kluge L, Bergh C, Einarsson S, Pinborg A, Mikkelsen Englund AL, Thurin-Kjellberg A. Cumulative live birth rates after weight reduction in obese women scheduled for IVF: follow-up of a randomized controlled trial. Hum Reprod Open. 2019 Dec 10;2019(4):hoz030. doi: 10.1093/hropen/hoz030. eCollection 2019.
- Derived from this study: PubMed 28854592Einarsson S, Bergh C, Friberg B, Pinborg A, Klajnbard A, Karlstrom PO, Kluge L, Larsson I, Loft A, Mikkelsen-Englund AL, Stenlof K, Wistrand A, Thurin-Kjellberg A. Weight reduction intervention for obese infertile women prior to IVF: a randomized controlled trial. Hum Reprod. 2017 Aug 1;32(8):1621-1630. doi: 10.1093/humrep/dex235.
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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.
Ann Thurin Kjellberg, MD PhD principal investigator
Sahlgrenska University Hospital
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low calorie diet treatment in people with Infertility and Obesity, run by Sahlgrenska University Hospital at 9 sites in 3 countries.
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 5 inclusion and 7 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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark, Sweden, Iceland. 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?
Live birth (time frame: Approximately 10-16 months after randomization, depending on study group.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01566929, which also lists 3 linked publications.
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 7 Sep 2018.