SubfertilityPhase 4NCT02487940
Assessment of Intralipid Efficacy in Women With Unexplained Recurrent Implantation Failure
A Phase 4 study testing Intralipid 20% and Normal saline in people with Subfertility, run by Dar El Teb Institute.
Trial summary
The study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle. Patients fulfilling the inclusion criteria will be randomised into two groups. Study Group: This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Intralipid 20% and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Apr 2015
- 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 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-38 years of age.
- Repeated implantation failure with 3 or more failed IVF cycles with good quality embryos.
- Normal trans-vaginal ultrasonography.
- Normal hysteroscopy.
- Normal male and female karyotyping.
- Normal anti cardiolipin antibody IGG, IGM and Lupus anticoagulant.
- Normal thrombophilia screen in the form of protein c, s, anti thrombin iii and factor v leiden.
- Written and signed informed consent by the patient to participate in the study.
Who cannot join
- Age more than 38 years.
- Less than 3 failed IVF cycles.
- Poor embryo quality.
- Expected poor ovarian response.
- Abnormal trans-vaginal ultrasound findings e.g. endometrial polyps or fibroids.
- Abnormal male or female karyotyping.
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- Abnormal hysteroscopic finding e.g. endometrial polyps, endometrial hyperplasia, fibroid or congenital anomalies.
- Positive Anticardiolipin antibodies or Lupus anticoagulant.
- Positive thrombophilia screen.
- Allergy to soy oil, eggs, peanut, peanut-based products or any active ingredient in the infusion.
- Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
About this study
Official title: Assessment of the Efficacy of Intralipid 20% in Management of Women With Unexplained Recurrent Implantation Failure in IVF Cycles: A Double Blinded Randomised Controlled Trial
The study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle.
Patients fulfilling the inclusion criteria will be randomised into two groups.
Read more
Study Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
Control Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
Read the detailed description
The study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle.
Randomisation:
Patients fulfilling the inclusion criteria will randomised to two groups.
Study Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
Control Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
Random allocation sequence generation:
A computer generated list will be used, assigning each participant number to either study groups.
Allocation Concealment:
Assignment will be done by sequentially numbered, otherwise identical, sealed envelopes (SNOSE), each containing a 2-inch by 2-inch paper with a written code designating the assigned group. These papers will be placed in a folded sheet of aluminium foil fitted inside the envelope. Effort will be taken to assure absence of any detectable differences in size or weight between intervention and control envelopes. Envelopes will be chosen to be opaque and lined inside with carbon paper. Envelopes will be opened sequentially only after writing the subject's tracking information on the envelope so that the carbon paper served as an audit trail.
Blinding:
Both drug with active ingredient and placebo will be provided by the hospital pharmacy in identical sealed opaque containers, equal in weight, similar in appearance, and tamper-proof. The drug with the active ingredient containers will be labeled either Group A or Group B by the head pharmacist and the assignment kept secret to be revealed after the end of the study.
Drugs will be administered to patients by a sealed opaque infusion drip.
IVF/ICSI cycle will be done using the standard LLP in both groups.
Primary outcome will be Live birth rates.
Secondary outcomes will be clinical pregnancy rates and side effects/tolerability of Intralipid infusion.
- Conditions
- Subfertility
- Being tested
- Intralipid 20%, Normal saline
- Keywords
- Recurrent implantation failure, IVF, ICSI, Intralipid
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralipid 20%Drug
Also called Lipofundin 20%
Women with RIF received intralipid 20% (at a dose of 9mg/mL of the total blood volume, corresponding to 2 mL intralipid diluted at 20% in 250 mL normal saline) given over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.
Normal salineDrug
Also called Solution of sodium chloride
Women with RIF received intravenous infusion of 250 mL physiological saline solution over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.
| Study group | Role | What they receive |
|---|---|---|
| Intralipid | Active comparator | Women with RIF received intralipid 20% (at a dose of 9mg/mL of the total blood volume, corresponding to 2 mL intralipid diluted at 20% in 250 mL normal saline) given over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan. Receives: Drug: Intralipid 20% |
| Placebo | Placebo comparator | Women with RIF received intravenous infusion of 250 mL physiological saline solution over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rates
Measured: up to 40 weeks gestation
Secondary outcomes (2)
Clinical pregnancy rates
Measured: 6 weeks gestation (2 weeks following embryo transfer)
side effects and tolerability of Intralipid
Measured: up to 40 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startOct 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dar El Teb Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ISLAM GAMALELDIN, Dar El Teb Institute
- Investigators
- Mostafa Gomaa, MD, Study director, Ain Shams univeristy hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487940
- Sponsor's protocol ID
- ASUH1234
- Status last verified
- Dec 2016
- First submitted
- 30 Jun 2015
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Intralipid 20% in Management of Women With Unexplained Recurrent Implantation Failure in IVF Cycles: A Double Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02487940
- Acronym / sponsor ID
- ASUH1234
- Conditions
- Subfertility
- Keywords
- Recurrent implantation failure, IVF, ICSI, Intralipid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dar El Teb InstituteUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Jul 2015 (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 study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle.
Patients fulfilling the inclusion criteria will be randomised into two groups.
Study Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
Control Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
Detailed description
The study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle.
Randomisation:
Patients fulfilling the inclusion criteria will randomised to two groups.
Study Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
Control Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
Random allocation sequence generation:
A computer generated list will be used, assigning each participant number to either study groups.
Allocation Concealment:
Assignment will be done by sequentially numbered, otherwise identical, sealed envelopes (SNOSE), each containing a 2-inch by 2-inch paper with a written code designating the assigned group. These papers will be placed in a folded sheet of aluminium foil fitted inside the envelope. Effort will be taken to assure absence of any detectable differences in size or weight between intervention and control envelopes. Envelopes will be chosen to be opaque and lined inside with carbon paper. Envelopes will be opened sequentially only after writing the subject's tracking information on the envelope so that the carbon paper served as an audit trail.
Blinding:
Both drug with active ingredient and placebo will be provided by the hospital pharmacy in identical sealed opaque containers, equal in weight, similar in appearance, and tamper-proof. The drug with the active ingredient containers will be labeled either Group A or Group B by the head pharmacist and the assignment kept secret to be revealed after the end of the study.
Drugs will be administered to patients by a sealed opaque infusion drip.
IVF/ICSI cycle will be done using the standard LLP in both groups.
Primary outcome will be Live birth rates.
Secondary outcomes will be clinical pregnancy rates and side effects/tolerability of Intralipid infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralipid | Active comparator | Drug: Intralipid 20%Women with RIF received intralipid 20% (at a dose of 9mg/mL of the total blood volume, corresponding to 2 mL intralipid diluted at 20% in 250 mL normal saline) given over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan. |
| Placebo | Placebo comparator | Drug: Normal salineWomen with RIF received intravenous infusion of 250 mL physiological saline solution over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 20-38 years of age.
- Repeated implantation failure with 3 or more failed IVF cycles with good quality embryos.
- Normal trans-vaginal ultrasonography.
- Normal hysteroscopy.
- Normal male and female karyotyping.
Key exclusion criteria (11 listed)
- Age more than 38 years.
- Less than 3 failed IVF cycles.
- Poor embryo quality.
- Expected poor ovarian response.
- Abnormal trans-vaginal ultrasound findings e.g. endometrial polyps or fibroids.
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 |
|---|---|---|
| Intralipid 20%Also: Lipofundin 20%Women with RIF received intralipid 20% (at a dose of 9mg/mL of the total blood volume, corresponding to 2 mL intralipid diluted at 20% in 250 mL normal saline) given over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan. | Drug | Intralipid |
| Normal salineAlso: Solution of sodium chlorideWomen with RIF received intravenous infusion of 250 mL physiological saline solution over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan. | Drug | Placebo |
Primary outcome
Live birth rates
Time frame: up to 40 weeks gestation
2 secondary outcomes
Clinical pregnancy rates
Time frame: 6 weeks gestation (2 weeks following embryo transfer)
side effects and tolerability of Intralipid
Time frame: up to 40 weeks gestation
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 29 Dec 2016.
- Individual participant dataSharing planned: Yes
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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.
Mostafa Gomaa, MD study director
Ain Shams univeristy hospitals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intralipid 20% and Normal saline in people with Subfertility, run by Dar El Teb Institute.
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 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: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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 rates (time frame: up to 40 weeks gestation). 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 29 Dec 2016.