Pregnancy Complicated by Low Implantation Clinical Trial
— ILRIFRMOfficial title:
Phase 4 Study of the Efficacy of Intralipid Treatment in Patients With Recurrent Implantation Failure and Miscarriages With High Peripheral and Uterine Natural Killer Cells
| NCT number | NCT01679561 |
| Other study ID # | ILRIFRM |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | February 2012 |
| Est. completion date | December 2013 |
| Verified date | January 2021 |
| Source | Woman's Health University Hospital, Egypt |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Both organ-specific and systemic autoimmunity are associated with an increased prevalence of recurrent miscarriage and reproductive failure, rendering the role of the maternal immunological system in fertility a key concept. It is believed by some that central to this theme is the maternal cytokine profile, with particularly T-helper (Th) cells. Immune modulating therapies have therefore been mooted as potential therapeutic strategies. Recent reports of high pregnancy rates achievable in women with RIF have added fuel to the debate regarding the effectiveness of intralipids in modulating the immune system.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2013 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility | Inclusion Criteria: 1. Recurrent unexplained failed IVF, ICSI. 2. Recurrent unexplained miscarriages. 3. High level of peripheral and uterine NK. Exclusion Criteria: 1. Age above forty years old. 2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice). 3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy). 4. Fibroids distorting uterine cavity. 5. Abnormal parental karyotype. 6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE). |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Women's Health Hospital | Assiut |
| Lead Sponsor | Collaborator |
|---|---|
| Woman's Health University Hospital, Egypt |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The effectiveness of intralipid on normalization of nk level and rate of clinical pregnancy . | Two hundreds patients (group1) with abnormal NK activity results (NKa)will receive intralipids 20% i.v. (9 mg/mL total blood volume -corresponds to 2 mL of intralipids 20% diluted in 250 mL saline; or 18 mg/mL - corresponds to 4 mL of intralipid 20% diluted in 250 mL saline) infusions and their NKa will be tested periodically. The determination of NK cell function will be performed by flow cytometry using K562 cells as targets,then follow up of the patients by the Doppler of endometrial blood follow at the time of luteal phase,and the clinical pregnancy rate.Group(2)of 200 patients will receive other routine measures. | 2 ys | |
| Secondary | the rate of continuation of pregnancy beyond 12 weeks of pregnancy,the adverse effects related to the drug. | Two hundreds patients (group1) with abnormal NK activity results (NKa) will receive intralipids 20% i.v. (9 mg/mL total blood volume -corresponds to 2 mL of intralipid 20% diluted in 250 mL saline; or 18 mg/mL - corresponds to 4 mL of intralipid 20% diluted in 250 mL saline) infusions and their NKa were tested periodically. The determination of NK cell function will be performed by flow cytometry using K562 cells as targets,then follow up of the patients by the Doppler of endometrial blood follow at the time of luteal phase,and the clinical pregnancy rate.Group(2)of 200 patients will receive routine measures. | 2 ys |