Intralipid Therapy for Recurrent Implantation Failure and Recurrent Miscarriages: Is it a Hope or Myth?A Randomized Clinical Trial

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Woman's Health University Hospital, Egypt
• Treatments: Soybean oil, phospholipid emulsion

Criteria

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).