Status:
COMPLETED
Nasal Oxcytocin During IUI
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Organon GmbH (former name)
Essex Pharma GmbH
Conditions:
Idiopathic Infertility
Eligibility:
All Genders
18-43 years
Phase:
NA
Brief Summary
Placebo-controlled study. Application of nasal oxytocin (8 IU) during intrauterine insemination in 86 patients.
Detailed Description
Between 2004 and 2007, 86 patients with primary or secondary infertility were enrolled in this prospective, randomized, double-blinded study in our tertiary-care infertility center. A total of 132 hom...
Eligibility Criteria
Inclusion
- Inclusion criteria for couples were idiopathic infertility, polycystic ovary syndrome (PCOS) and / or male subfertility.
- Age 18-42
- In all patients fallopian tubes were documented to be patent by sonographic contrast hysterosalpingography (Echovist® 200, Bayer Vital GmbH, Leverkusen, Germany) or by chromo-laparoscopy.
- Infections with Hepatitis B and C and HIV were excluded in all couples by negative serological tests.
- In all patients protective titers against rubella virus were confirmed.
Exclusion
- Patients displaying signs or symptoms of anomalies such as uterine fusion defects, submucosal fibroids, active endometriosis or acute inflammation were excluded from the study.
- Further prerequisites were endocrine serum parameters (FSH, LH, estradiol, testosterone, SHBG, DHEA-S, Prolaktin, TSH) from cycle day 2-5 within the normogonadotropic range with no evidence of hyperandrogenemia, thyroid dysfunction or hyperprolactinemia. 1
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00805662
Start Date
May 1 2003
End Date
January 1 2008
Last Update
December 9 2008
Active Locations (1)
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1
Dept. of Obstetrics and Gynecology
Munich, Germany, 81377