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

NCT ID: NCT01679561

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-12-31

Brief 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.

Detailed Description

The investigators would like to assess if that intralipids therapy is an effective treatment for women undergoing repeated failed assisted reproduction cycles and recurrent miscarriages against traditional methods in randomised clinical trial (RCT).

Conditions

Pregnancy Complicated by Low Implantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intralipids

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 intralipids 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 180 patients will receive placebo.

Group Type: EXPERIMENTAL

intralipid

Intervention Type: DRUG

intravenous intralipid 20% is given to the patients known to be have either recurrent failed IVF, RPL

Interventions

intralipid

intravenous intralipid 20% is given to the patients known to be have either recurrent failed IVF, RPL

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Woman's Health University Hospital, Egypt

OTHER

Sponsor Role: lead

Responsible Party

alaa eldeen mahmoud ismail

M D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa M Ismail, M D

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine,Assiut university,Egypt

Locations

Women's Health Hospital

Asyut, , Egypt

Countries

Egypt

Other Identifiers

ILRIFRM

Identifier Type: -

Identifier Source: org_study_id