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

Abbott

Status and phase: Completed; Phase 3

Conditions: Recurrent Miscarriage

Treatments: Drug: Placebo; Drug: Dydrogesterone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00193674

S102.3.116

Details and patient eligibility

About

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).

Enrollment: 71 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Dydrogesterone

2

Placebo Comparator group

Treatment:

Drug: Placebo