InfertilityPhase 4SETARTNCT01892111
Physical Activity and ARTs
A Phase 4 study testing Structured exercise program. in people with Infertility and Obesity, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
Obese women experience increased infertility rate and longer time to conception showing lower pregnancy and live-birth rates both in natural and assisted conceptions. Body weight loss improves not only spontaneous pregnancy rates but also those of assisted reproductive techniques (ARTs). Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility, Obesity, Stable BMI
- What is being tested?
- Structured exercise program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2013to Jun 2014
- Phase
- Phase 4
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertility
- obesity
- stable BMI
- schedule for ARTs
Who cannot join
- use of cryopreserved embryos
- any changes in diet and physical activity
- tobacco smoking
- drug use
- alcohol abuse
- uterine diseases
Show all 11Show fewer
- previous pelvic surgery
- major medical diseases
- clinical history of (or suspicion of) endometriosis, antiphospholipid antibody syndrome, recurrent miscarriage
- obese partner
- severe sperm pathology
Trial locations and contacts
1 site in 1 country.
Stefano Palomba, MD contact
Italy1 site
Unit of Gynecology & Obstetrics - Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, University of Modena and Reggio Emilia
Reggio Emilia, 42123
Stefano Palomba, MD, stefanopalomba@tin.it
Stefano Palomba, MD
About this study
Official title: Structured Exerise Training in Infertile Obese Patients Treated With Assisted Reproductive Techniques: a Randomized Controlled Trial
Obese women experience increased infertility rate and longer time to conception showing lower pregnancy and live-birth rates both in natural and assisted conceptions. Body weight loss improves not only spontaneous pregnancy rates but also those of assisted reproductive techniques (ARTs). Almost all studies refer to body weight loss due to lifestyle intervention programs consisting in hypocaloric diet and increased physical activity, whereas very little is known about the specific effects of physical activity alone on human reproduction.
In a previous retrospective study, we demonstrated that physical activity enhances the reproductive performance of obese infertile patients who receive in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles, regardless of body weight loss.
The aim of this randomized controlled trial (RCT) will be to evaluate if a structured exercise program improve the effectiveness of ARTs.
Read the detailed description
Women with primary infertility scheduled to an IVF/ICSI procedure, obese and with a stable BMI will be randomized to receive a structured exercise program or nothing.
Patients will undergo a gonadotropin ovarian hyperstimulation for standard IVF/ICSI procedure.
clinical and biological data will be evaluated in each subject.
- Conditions
- Infertility, Obesity, Stable BMI
- Being tested
- Structured exercise program.
- Keywords
- SET, infertility, IVF/ICSI, pregnancy
- Medical subject headings
- Infertility, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured exercise program.Other
| Study group | Role | What they receive |
|---|---|---|
| structured exercise program (SET) | Experimental | SET one month before and during ARTs. IVF/ICSI procedure. Receives: Other: Structured exercise program. |
| no intervention | No intervention | IVF/ICSI procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate.
Measured: 4 months
Secondary outcomes (7)
stimulation lenght and dose
Measured: 1 month
cancellation rate
Measured: 1 months
implantation rate
Measured: 1 month
OHSS rate
Measured: 1 month
embryo transferred
Measured: 1 month
miscarriage rate
Measured: 4 months
multiple pregnancy rate
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Palomba, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892111
- Sponsor's protocol ID
- 1/2013
- Acronym
- SETART
- Status last verified
- Jun 2013
- First submitted
- 28 Jun 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
Publications
Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21.
PubMed 20858697Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.
PubMed 18158291
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Exerise Training in Infertile Obese Patients Treated With Assisted Reproductive Techniques: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01892111
- Acronym / sponsor ID
- SETART / 1/2013
- Conditions
- Infertility, Obesity, Stable BMI
- Keywords
- SET, infertility, IVF/ICSI, pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 3 Jul 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.
Obese women experience increased infertility rate and longer time to conception showing lower pregnancy and live-birth rates both in natural and assisted conceptions. Body weight loss improves not only spontaneous pregnancy rates but also those of assisted reproductive techniques (ARTs). Almost all studies refer to body weight loss due to lifestyle intervention programs consisting in hypocaloric diet and increased physical activity, whereas very little is known about the specific effects of physical activity alone on human reproduction.
In a previous retrospective study, we demonstrated that physical activity enhances the reproductive performance of obese infertile patients who receive in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles, regardless of body weight loss.
The aim of this randomized controlled trial (RCT) will be to evaluate if a structured exercise program improve the effectiveness of ARTs.
Detailed description
Women with primary infertility scheduled to an IVF/ICSI procedure, obese and with a stable BMI will be randomized to receive a structured exercise program or nothing.
Patients will undergo a gonadotropin ovarian hyperstimulation for standard IVF/ICSI procedure.
clinical and biological data will be evaluated in each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| structured exercise program (SET) | Experimental | Other: Structured exercise program.SET one month before and during ARTs. IVF/ICSI procedure. |
| no intervention | No intervention | –IVF/ICSI procedure. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- infertility
- obesity
- stable BMI
- schedule for ARTs
Key exclusion criteria (11 listed)
- use of cryopreserved embryos
- any changes in diet and physical activity
- tobacco smoking
- drug use
- alcohol abuse
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 |
|---|---|---|
| Structured exercise program. | Other | structured exercise program (SET) |
Primary outcome
pregnancy rate.
Time frame: 4 months
7 secondary outcomes
stimulation lenght and dose
Time frame: 1 month
cancellation rate
Time frame: 1 months
implantation rate
Time frame: 1 month
OHSS rate
Time frame: 1 month
embryo transferred
Time frame: 1 month
miscarriage rate
Time frame: 4 months
multiple pregnancy rate
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Background: PubMed 20858697Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21.
- Background: PubMed 18158291Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.
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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.
Stefano Palomba, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Structured exercise program. in people with Infertility and Obesity, run by University of Modena and Reggio Emilia at 1 site in Italy.
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 4 inclusion and 11 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 3 Jul 2013. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Stefano Palomba, MD (stefanopalomba@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate. (time frame: 4 months). 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 NCT01892111, which also lists 2 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 3 Jul 2013.