Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage

Oral Dydrogesterone Treatment During the First Trimester of Pregnancy in Women With Recurrent Miscarriage: A Double-Blind, Prospectively Randomized, Placebo-Controlled, Parallel Group Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193674

Enrollment

Registered

2005-09-19

Start date

2003-09-30

Completion date

2009-07-31

Last updated

2011-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Miscarriage

Keywords

Pregnancy, Immunology, Unexplained recurrent miscarriage

Brief summary

The purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to non-inflammatory cytokines in women suffering from habitual abortion treated with dydrogesterone (Duphaston).

Interventions

DRUGDydrogesterone

20 mg/day, oral

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 38 Years

Healthy volunteers

Inclusion criteria

* Women with a history of idiopathic recurrent miscarriage, based on a documented history of at least three spontaneous consecutive miscarriages before 20 weeks gestation with the same partner

Exclusion criteria

* Any verifiable cause of the recurrent miscarriages apart from luteal phase defect (e.g. systemic lupus erythematosus \[SLE\], infections with chlamydia or mycoplasma) * Any gynecological neoplasias or anatomical abnormalities that oppose pregnancy * Concurrent infertility treatment/superovulation protocol

Design outcomes

Primary

Measure	Time frame
Cytokine ratio IFN/IL-10	14 weeks treatment after diagnosed pregnancy (week of gestation 4 to 18)

Secondary

Measure	Time frame
Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone	First trimester of pregnancy

Countries

Austria, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026