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CompletedNCT00722475Updated Nov 6, 2014

Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage

A Phase 3 interventional study of Intravenous immunoglobulin and Human albumin in Secondary Recurrent Miscarriage, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-11-06.

Sponsored by Rigshospitalet, Denmark · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Secondary Recurrent Miscarriage

Keywords

  • recurrent miscarriage
  • immunology
  • intravenous immunoglobulin
  • miscarriage
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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 82 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    IvIg

    Repeated infusions of intravenous immunoglobulin in early pregnancy

    Drug: Intravenous immunoglobulin

  • Placebo comparator
    placebo

    infusion of human albumin CSL Behring 5%

    Drug: Human albumin

Interventions

  • DrugIntravenous immunoglobulin

    Intravenous infusions, 25-35 g each time, 4th to 15th gestational week

    Also known as: Intravenous immunoglobulin Privigen CSL Behring 100mg/ml

  • DrugHuman albumin

    Repeated infusions of Human Albumin 5%, 250-350 ml between 4th and 15th gestational week

    Also known as: Human Albumin 5% CSL Behring

06

What researchers measure

Primary outcomes

  1. The difference in the subsequent livebirth rate among patients with secondary recurrent miscarriage who, during the trial, receive intravenous immunoglobulin or placebo, respectively, without any exclusions (ITT analysis)

    Time frame: August 2008 to June 2011

Secondary outcomes

  1. The difference in the subsequent livebirth rate among women with secondary recurrent miscarriage who receive intravenous immunoglobulin or placebo, respectively, after relevant and predefined exclusions (PP analysis).

    Time frame: August 2008 to June 2011

07

Study locations

1 site
  • Fertility Clinic 4071, Rigshospitalet
    Copenhagen, DK-2100, Denmark
08

References and documents

Publications

  • Hutton B, Sharma R, Fergusson D, Tinmouth A, Hebert P, Jamieson J, Walker M. Use of intravenous immunoglobulin for treatment of recurrent miscarriage: a systematic review. BJOG. 2007 Feb;114(2):134-42. doi: 10.1111/j.1471-0528.2006.01201.x. Epub 2006 Dec 12. PubMed 17166218 ↗
  • Christiansen OB, Pedersen B, Rosgaard A, Husth M. A randomized, double-blind, placebo-controlled trial of intravenous immunoglobulin in the prevention of recurrent miscarriage: evidence for a therapeutic effect in women with secondary recurrent miscarriage. Hum Reprod. 2002 Mar;17(3):809-16. doi: 10.1093/humrep/17.3.809. PubMed 11870141 ↗
  • Christiansen OB, Mathiesen O, Lauritsen JG, Grunnet N. Intravenous immunoglobulin treatment of women with multiple miscarriages. Hum Reprod. 1992 May;7(5):718-22. doi: 10.1093/oxfordjournals.humrep.a137724. PubMed 1639992 ↗
  • Christiansen OB, Mathiesen O, Husth M, Rasmussen KL, Ingerslev HJ, Lauritsen JG, Grunnet N. Placebo-controlled trial of treatment of unexplained secondary recurrent spontaneous abortions and recurrent late spontaneous abortions with i.v. immunoglobulin. Hum Reprod. 1995 Oct;10(10):2690-5. doi: 10.1093/oxfordjournals.humrep.a135769. PubMed 8567794 ↗
  • Egerup P, Kolte AM, Larsen EC, Krog M, Nielsen HS, Christiansen OB. Recurrent pregnancy loss: what is the impact of consecutive versus non-consecutive losses? Hum Reprod. 2016 Nov;31(11):2428-2434. doi: 10.1093/humrep/dew169. Epub 2016 Sep 2. PubMed 27591241 ↗
  • Christiansen OB, Larsen EC, Egerup P, Lunoee L, Egestad L, Nielsen HS. Intravenous immunoglobulin treatment for secondary recurrent miscarriage: a randomised, double-blind, placebo-controlled trial. BJOG. 2015 Mar;122(4):500-8. doi: 10.1111/1471-0528.13192. Epub 2014 Nov 21. PubMed 25412569 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00722475
Lead sponsor
Rigshospitalet, Denmark
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
Responsible party
Ole B Christiansen (consultant, Rigshospitalet, Denmark) — Principal investigator
First posted
Jul 25, 2008
Start date
Aug 2008
Primary completion
May 2014
Completion
May 2014
Last update
Nov 6, 2014

Study contacts

Ole B. Christiansen, MD, D.M.Sc.
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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