Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind Trial of Intravenous Immunoglobulin for Women With Unexplained Secondary Recurrent Miscarriage
Brief Summary: The investigators want to test whether infusions of intravenous immunoglobulin - a blood product known to modify immune responses - in early pregnancy will increase the chance of a subsequent live birth in women with three or more miscarriages after a birth and a total of at least four miscarriages. This will be done in a trial where 82 patients will be randomly allocated to infusions with intravenous immunoglobulin or placebo during pregnancy.


Options:
A: Inclusion Criteria:

* 4 or more miscarriages before the end of gestational week 14 in patients with secondary recurrent miscarriages.
* At least three of these must be consecutive after the previous birth
* At least two of the miscarriages with the present partner.

Exclusion Criteria:

* Age below 18 or above 41 years at conception
* Significant uterine anomalies detected by hysterosalpingography, hysteroscopy or hydrosonography.
* Significant chromosomal aberrations in the couple
* Menstrual cycle \< 23 or \> 35 days
* Presence of lupus anticoagulant or IgG anticardiolipin concentration \>= 40 GPL ku/l or plasma homocystein \>= 25 microg./l by repeated measurements at 8 weeks intervals
* Tests positive for HIV or tests indicating carriage of hepatitis B or C
* IgA deficiency
* Allergy to albumin, IvIg or one of the substances added to preserve the drugs.
* Presence of chronic disease, which necessitate permanent treatment with e.g. corticosteroids , non-steroidal antiinflammatory drugs, anticoagulation, simvastatin or imurel from the start of pregnancy.
* Less than 2 of the previous pregnancy losses documented by ultrasound or uterine curettage.
* Present pregnancy a result of donor insemination or egg donation.
* Planned administration of gestagens or estrogens from the beginning of pregnancy.
* 3 or more previous IVF/ICSI/FER attempts resulting in chemical pregnancy/miscarriage.
* Previous participation in the trial.
B: Inclusion Criteria:

1. All women with recurrent first-trimester miscarriage and all women with one or more second-trimester miscarriage who screened before pregnancy for antiphospholipid antibodies.
2. To diagnose antiphospholipid syndrome it is mandatory that the woman has two positive tests at least 12 weeks apart for either lupus anticoagulant or anticardiolipin antibodies of immunoglobulin G and/or immunoglobulin M class present in a medium or high titre over 40 g/l or ml/l,or above the 99th percentile).

In the detection of lupus anticoagulant, the dilute Russell's viper venom time test together with a platelet neutralisation procedure is more sensitive and specific than either the activated partial thromboplastin time test or the kaolin clotting time test. Anticardiolipin antibodies are detected using a standardised enzyme linked immunosorbent assay.

Exclusion Criteria:

1. Age above forty years old .
2. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
3. Fibroids distorting uterine cavity .
4. Abnormal parental karyotype .
5. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
C: Inclusion Criteria:

* Confirmed pregnancy;
* 18 years or older;
* Two or more unexplained pregnancy loss before the 10th week of gestation, AND/OR one or more unexplained pregnancy loss at or beyond the 10th week of gestation;
* One or more APS laboratory criteria present, according to the revised Sapporo criteria;

Exclusion Criteria:

* Greater than 11 weeks +6 days gestational age at time of randomization;
* Indication(s) for prophylactic or therapeutic-dose anticoagulation;
* Contraindication to heparin or aspirin;
* Received 7 or more doses of LMWH;
* Previous participation in the trial;
* Geographic inaccessibility;
* Refused consent.
D: Inclusion Criteria:

* Couple has a history of unexplained secondary recurrent miscarriage.
* Most recent pregnancy occurred within one year of discontinuing contraception.

Exclusion Criteria:

* Maternal IgA deficiency
* Maternal history of immunoglobulin hypersensitivity.
* Maternal contraindication to pregnancy.
* Evidence of active hepatitis or immunocompromised state in either partner.
* Concomitant use of medication(s) for treatment of recurrent miscarriage, such as but not limited to progesterone, clomiphene citrate, acetylsalicylic acid, heparin, glucocorticoids or hCG injections.

Answer: A