INTRAVENOUS IMMUNOGLOBULIN HUMAN FOR THE TREATMENT OF ABORTIO

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Signed informed consent before any assessment and intervention on the patient.
Women with three consecutive spontaneous abortions, 18 to 37 years of age, inclusive
Circulating cytotoxic NK cells (CD3-CD56 + CD16 +) with a value of 13% of total lymphocytes in 35 years or more and less than 22% in 35 years or NKT cells ?10% of total lymphocytes .
Weight Between 40 kg and 90 kg, inclusive.
Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Medication use prohibited in the study.
Known hypersensitivity to immunoglobulins
Recent clinically significant bacterial infection.
Immunodeficiency diseases, including HIV.
Hepatitis B or C and / or positive hepatitis B surface antigen (HBsAg) or hepatitis C test at screening, at the present time.
Alcohol abuse at present or during the previous 12 months.
Participation in any clinical trial with an experimental drug or affect the ability or maintenance of conception in the 4 weeks prior to the first dose.
Any other condition in the investigator's opinion may make the patient inappropriate for entry into the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that treatment with IVIG in patients with recurrent abortions and expansion of NK and NKT cells in peripheral blood increases the proportion of live births.;Secondary Objective: ? To evaluate the profile of Th1 / Th2 / Th17 / Treg and chemokines in plasma prior to and during treatment with IVIG in patients with recurrent abortions.<br> ? To evaluate the percentage and phenotype of NK cells and T regulatory circulating before and during treatment with IVIG in patients with recurrent abortions.<br> ? To assess the safety of IVIg in patients with recurrent abortions.<br> ? To evaluate the safety of live births to mothers exposed to IVIG.<br> ? To evaluate the quality of life of mothers of newborns alive after IVIG administration.;Primary end point(s): new born number;Timepoint(s) of evaluation of this end point: at the end of the pregnancy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Number of pregnancies achieved<br> 2. Quality of Life<br> 3. Gestation time <br> 4. Proportion of congenital malformations.<br> 5. Rate of postpartum infection<br> 6. Percentile of height, weight and head circumference of the newborn<br> 7. Newborn neurologic development;Timepoint(s) of evaluation of this end point: 3-4 after pregncancy