In Vitro FertilizationNCT01343992
Bed Rest or no Bed Rest?
A study testing Bed rest and No bedrest in people with In Vitro Fertilization, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
A comparative study to determine whether bed rest after embryo transfer (ET) affects on IVF (In Vitro Fertilization)outcome. This study includes 240 patients undergoing IVF treatment with donated oocytes. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- In Vitro Fertilization
- What is being tested?
- Bed rest and No bedrest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- May 2011to Nov 2011
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertile Patients with fertility problems due to tubaric or ovarian problems with normozoospermatic couple
- Patient and her couple with ages between ages 20 - 49 years old
- BMI < 25 kg/m2
- IVF treatment with oocyte donation
- Elective transfer of 2 embryos of day 3 embryos or day 5/6 embryos transferred
- First cycle of embryo transfer
Who cannot join
- Patients with uterine abnormalities, significant uterine fibroids, Hydrosalphinx
- History of recurrent pregnancy loss
- severe male factor were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Influence of Bed Rest After Embryo Transfer in Outcome of IVF Treatment With Ovum Donation.
A comparative study to determine whether bed rest after embryo transfer (ET) affects on IVF (In Vitro Fertilization)outcome. This study includes 240 patients undergoing IVF treatment with donated oocytes. All the procedures of IVF, of the embryo transfer, and of the administration of medications are performed as always and there are no variations. The only highlighted procedure in this study is immediately after the embryo transfer. There are two groups: one which will rest in bed for 10 minutes after the transfer and one which will not rest after the transfer. Both procedures are common, usually depending on the habitual clinical practice of each clinic internationally. Patients from both group receive the routine post transfer instructions and treatment.
- Conditions
- In Vitro Fertilization
- Being tested
- Bed rest, No bedrest
- Keywords
- Embryo transfer, Implantation rate, Pregnancy rate, bedrest, neutral, benevolent, deterious, implantation, gestation rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed restBehavioural
Patients will rest in bed ten minutes after the embryo transfer.
No bedrestBehavioural
Patients will not rest in bed after the embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| Bedrest | Active comparator | Patients will rest in bed ten minutes after the embryo transfer. Receives: Behavioral: Bed rest |
| No bed rest | Experimental | Patients will not rest after the embryo transfer. Receives: Behavioral: No bedrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth infant rate after delivery from both groups of study
Whether bed rest after embryo transfer affects the pregnancy rate in IVF treatment with oocyte donation.
Measured: 10 months
Secondary outcomes (6)
Implantation rate
Measured: 2 months
Miscarriage rate
Measured: 5 months
Birth weight of live newborn infant after delivery
Measured: 10 months
Birth height of live newborn infant after delivery
Measured: 10 months
Cranial perimeter of live newborn infant after delivery
Measured: 10 months
APGAR score of live newborn infant after delivery
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for In Vitro FertilizationStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Remohi, Instituto Valenciano de Infertilidad, IVI VALENCIA
- Investigators
- Dr. Sharayi Gaikwad, MD, Principal investigator, Instituto Valenciano de Infertilidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343992
- Sponsor's protocol ID
- 0912-C-065-SA
- Status last verified
- Apr 2015
- First submitted
- 27 Apr 2011
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaikwad S, Garrido N, Cobo A, Pellicer A, Remohi J. Bed rest after embryo transfer negatively affects in vitro fertilization: a randomized controlled clinical trial. Fertil Steril. 2013 Sep;100(3):729-35. doi: 10.1016/j.fertnstert.2013.05.011. Epub 2013 Jun 10.
PubMed 23755954
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Bed Rest After Embryo Transfer in Outcome of IVF Treatment With Ovum Donation.
- ClinicalTrials.gov ID
- NCT01343992
- Acronym / sponsor ID
- 0912-C-065-SA
- Conditions
- In Vitro Fertilization
- Keywords
- Embryo transfer, Implantation rate, Pregnancy rate, bedrest, neutral, benevolent, deterious, implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 Apr 2011 (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.
A comparative study to determine whether bed rest after embryo transfer (ET) affects on IVF (In Vitro Fertilization)outcome. This study includes 240 patients undergoing IVF treatment with donated oocytes. All the procedures of IVF, of the embryo transfer, and of the administration of medications are performed as always and there are no variations. The only highlighted procedure in this study is immediately after the embryo transfer. There are two groups: one which will rest in bed for 10 minutes after the transfer and one which will not rest after the transfer. Both procedures are common, usually depending on the habitual clinical practice of each clinic internationally. Patients from both group receive the routine post transfer instructions and treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bedrest | Active comparator | Behavioral: Bed restPatients will rest in bed ten minutes after the embryo transfer. |
| No bed rest | Experimental | Behavioral: No bedrestPatients will not rest after the embryo transfer. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Infertile Patients with fertility problems due to tubaric or ovarian problems with normozoospermatic couple
- Patient and her couple with ages between ages 20 - 49 years old
- BMI < 25 kg/m2
- IVF treatment with oocyte donation
- Elective transfer of 2 embryos of day 3 embryos or day 5/6 embryos transferred
Key exclusion criteria (3 listed)
- Patients with uterine abnormalities, significant uterine fibroids, Hydrosalphinx
- History of recurrent pregnancy loss
- severe male factor were excluded from the study
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 |
|---|---|---|
| Bed restPatients will rest in bed ten minutes after the embryo transfer. | Behavioural | Bedrest |
| No bedrestPatients will not rest in bed after the embryo transfer. | Behavioural | No bed rest |
Primary outcome
Live birth infant rate after delivery from both groups of study
Time frame: 10 months
Whether bed rest after embryo transfer affects the pregnancy rate in IVF treatment with oocyte donation.
6 secondary outcomes
Implantation rate
Time frame: 2 months
Miscarriage rate
Time frame: 5 months
Birth weight of live newborn infant after delivery
Time frame: 10 months
Birth height of live newborn infant after delivery
Time frame: 10 months
Cranial perimeter of live newborn infant after delivery
Time frame: 10 months
APGAR score of live newborn infant after delivery
Time frame: 10 months
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 23 Apr 2015.
- Derived from this study: PubMed 23755954Gaikwad S, Garrido N, Cobo A, Pellicer A, Remohi J. Bed rest after embryo transfer negatively affects in vitro fertilization: a randomized controlled clinical trial. Fertil Steril. 2013 Sep;100(3):729-35. doi: 10.1016/j.fertnstert.2013.05.011. Epub 2013 Jun 10.
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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.
Dr. Sharayi Gaikwad, MD principal investigator
Instituto Valenciano de Infertilidad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed rest and No bedrest in people with In Vitro Fertilization, run by Instituto Valenciano de Infertilidad, IVI VALENCIA 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 6 inclusion and 3 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 23 Apr 2015. 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?
Live birth infant rate after delivery from both groups of study (time frame: 10 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 NCT01343992, which also lists 1 linked publication.
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 23 Apr 2015; AzTrials last refreshed its copy on 27 Oct 2026.