Infertility Due to NonimplantationPhase 2NCT03374163
Effect Of Intravenous IntralipidTherapyon Pregnancy Outcome in Women With History of Recurrent Implantation Failure Undergoing Intracytoplasmic Sperm Injection-Embryo Transfer Cycle: A Randomized Controlled Trial
A Phase 2 study testing intralipid 20% in people with Infertility Due to Nonimplantation, run by King Fahad Medical City.
Trial summary
To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI). Read more about this study
- Who is it for?
- Ages 21 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Due to Nonimplantation
- What is being tested?
- intralipid 20%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Jun 2017
- Phase
- Phase 2
- 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 21 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age < 42 years
- BMI < 30 kg/m2
- history of 3 or more recurrent implantation failure undergoing Intracytoplasmic Sperm Injection (ICSI ) cycle.
Who cannot join
- women with medical contraindications of intralipidinfusion.
- uterine fibroid.
- endometrial polyp.
- endometriosis,hydrosalpinx.
- intrauterine adhesion and uterine anomalies.
- Women with positive thrombophilia screen.
Show all 9Show fewer
- diminished ovarian reserve.
- severe male factor infertility .
- chronic medical illnesses which may contribute in impaired chance of pregnancy .
About this study
To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI).
Read the detailed description
the aim to evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI).
A total of 142 patients with history of unexplained RIF3 or more cycles were included in the study. Patient were randomized into two groups, study group (n=71) and control group (n=71). The study groupreceivedintralipid 20%infusionon the day of embryo transfer (ET) and a second dose on the day of pregnancy test. The control group underwent ET without intralipidinfusion.Allpatientswereclosely monitored for any side effectsincluding allergic reactions.
- Conditions
- Infertility Due to Nonimplantation
- Being tested
- intralipid 20%
- Keywords
- infertility , implantion failure, intracytoplasmic sperm injection
- 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
milky soulation for energey supplement.
| Study group | Role | What they receive |
|---|---|---|
| treatment group who recived intralipid | Experimental | 71 patients who recived intralipid on day of embryo transfer day, pregnancy day. Receives: Drug: intralipid 20% |
| control group | No intervention | 71 patient not recived intralipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
number of patient with positive b-hcg level 14 day post embryo transfer day.over the study population number in study period.
Measured: 14 day post embryo transfer day
Secondary outcomes (2)
miscarrage rate
number of patient with miscarrage over study population number in study period
Measured: miscarrage before 20 week gestation
live birth rate
number of patient with delivery after 28 week gestation over study population number in study period.
Measured: delivery after 28 week gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Jan 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility Due to NonimplantationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI). A total of 142 patients with history of unexplained RIF3 or more cycles were included in the study. Patient were randomized into two groups, study group (n=71) and control group (n=71). The study groupreceivedintralipid 20%infusionon the day of embryo transfer (ET) and a second dose on the day of pregnancy test. The control group underwent ET without intralipidinfusion.Allpatientswereclosely monitored for any side effectsincluding allergic reactions.
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, jawharah ali alzebidi, King Fahad Medical City
- Investigators
- solaiman s alobaid, MD, Principal investigator, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374163
- Sponsor's protocol ID
- 15-442
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Intravenous IntralipidTherapyon Pregnancy Outcome in Women With History of Recurrent Implantation Failure Undergoing Intracytoplasmic Sperm Injection-Embryo Transfer Cycle: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03374163
- Acronym / sponsor ID
- 15-442
- Conditions
- Infertility Due to Nonimplantation
- Keywords
- infertility , implantion failure, intracytoplasmic sperm injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 15 Dec 2017 (actual)
- 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.
To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI).
Detailed description
the aim to evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI).
A total of 142 patients with history of unexplained RIF3 or more cycles were included in the study. Patient were randomized into two groups, study group (n=71) and control group (n=71). The study groupreceivedintralipid 20%infusionon the day of embryo transfer (ET) and a second dose on the day of pregnancy test. The control group underwent ET without intralipidinfusion.Allpatientswereclosely monitored for any side effectsincluding allergic reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI). A total of 142 patients with history of unexplained RIF3 or more cycles were included in the study. Patient were randomized into two groups, study group (n=71) and control group (n=71). The study groupreceivedintralipid 20%infusionon the day of embryo transfer (ET) and a second dose on the day of pregnancy test. The control group underwent ET without intralipidinfusion.Allpatientswereclosely monitored for any side effectsincluding allergic reactions.
| Arm | Type | Receives |
|---|---|---|
| treatment group who recived intralipid | Experimental | Drug: intralipid 20%71 patients who recived intralipid on day of embryo transfer day, pregnancy day. |
| control group | No intervention | –71 patient not recived intralipid |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age < 42 years
- BMI < 30 kg/m2
- history of 3 or more recurrent implantation failure undergoing Intracytoplasmic Sperm Injection (ICSI ) cycle.
Key exclusion criteria (9 listed)
- women with medical contraindications of intralipidinfusion.
- uterine fibroid.
- endometrial polyp.
- endometriosis,hydrosalpinx.
- intrauterine adhesion and uterine anomalies.
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%milky soulation for energey supplement. | Drug | treatment group who recived intralipid |
Primary outcome
pregnancy rate
Time frame: 14 day post embryo transfer day
number of patient with positive b-hcg level 14 day post embryo transfer day.over the study population number in study period.
2 secondary outcomes
miscarrage rate
Time frame: miscarrage before 20 week gestation
live birth rate
Time frame: delivery after 28 week 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 15 Dec 2017.
- Individual participant dataSharing planned: Yes
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.
solaiman s alobaid, MD principal investigator
King Fahad Medical City
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intralipid 20% in people with Infertility Due to Nonimplantation, run by King Fahad Medical City.
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 3 inclusion and 9 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 15 Dec 2017. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
pregnancy rate (time frame: 14 day post embryo transfer day). 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 15 Dec 2017.