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OIL - BASED CONTRAST VERSUS WATER BASED CONTRAST MEDIA IN THE DIAGNOSIS OF TUBAL PATENCY AT HYSTEROSALPINGOGRAPHY

Phase 4
Conditions
tubal obstruction
uterus picture
10013356
Registration Number
NL-OMON32658
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
1080
Inclusion Criteria

* Age between 18 and 39 years
* Subfertility of at least one year
* Chlamydia Antibody Titre (CAT) negative (MIF <1:64 or ELISA <1:1)
* Low risk for tubal pathology according to the medical history (Coppus et al., 2007)
* Valid indication for HSG in the fertility work-up or before intra uterine insemination treatment.

Exclusion Criteria

* Endocrino-pathological disease as: Polycystic ovary syndrome, Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type I.
* Known or high risk for tubal pathology, CAT positive (MIF titre > 1:64 or ELISA > 1.1)
* Known contrast (iodine) allergy
* Male subfertility defined as a post-wash total motile sperm count < 3 x106 spermatozoa/ml
* If not willing or able to sign the consent form.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>ongoing pregnancy rates</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>live birth rate, miscarriages, ectopic pregnancy, pain score, coital frequency<br /><br>before and after HSG, pregnancy leading to live birth. </p><br>
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