Effect of Intralipid Infusion in Patients With Recurrent Implantation Failure
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|ClinicalTrials.gov Identifier: NCT02865785|
Recruitment Status : Unknown
Verified August 2016 by Mostafa Fouad Gomaa, Ain Shams University.
Recruitment status was: Recruiting
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Subfertility||Drug: Intralipid 20% Drug: Placebo||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Intralipid Infusion in Patients With Recurrent Implantation Failure (A Randomized Controlled Trial)|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||August 2017|
Active Comparator: Study Group
This group will include 160 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20% (100 mL of intralipid 20% diluted in 250 mL sterile i.v. saline administered i.v. over two hours), once between days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy test.
Drug: Intralipid 20%
intralipid D4-9 of induction ovulation to be repeated within 7 days of positive pregnancy test.
Other Name: lipofundin 20%
Placebo Comparator: Placebo Group
This group will include 160 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, once between days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy test.
saline infusion D4-9 of induction of ovulation to be repeated within 7 days of positive pregnancy test.
Other Name: saline 0.9%
- Live birth rate [ Time Frame: 38 gestational weeks ]
- Clinical pregnancy rate [ Time Frame: 6 gestational weeks ]
- Chemical pregnancy rate [ Time Frame: 6 gestational weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865785
|Contact: Khaled Afifi, MBBCH||01009981222||DrKhaledAfifi@hotmail.com|
|AinShams Maternity Hospital||Recruiting|
|Cairo, Egypt, 002|
|Contact: Khaled Afifi, MBBCH 01009981222 DrKhaledAfifi@hotmail.com|
|Study Director:||Khaled Afifi, MBBCH||Resident of O&G|