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Nasal Oxcytocin During IUI (Oxy)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00805662
First Posted: December 9, 2008
Last Update Posted: December 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Organon GmbH (former name)
Essex Pharma GmbH
Information provided by:
Ludwig-Maximilians - University of Munich
  Purpose
Placebo-controlled study. Application of nasal oxytocin (8 IU) during intrauterine insemination in 86 patients.

Condition Intervention
Idiopathic Infertility Drug: oxytocin, placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Nasal Oxcytocin Fails to Increase Pregnancy Rate of IUI

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Possible side effects: nasal mucosal irritation, headake, lower abdominal pain [ Time Frame: 10 minutes ]

Enrollment: 86
Study Start Date: May 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxytocin
Intranasal oxytocin during IUI
Drug: oxytocin, placebo
intranasal oxytocin during intrauterine insemination
Other Name: Synthocinon

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805662


Locations
Germany
Dept. of Obstetrics and Gynecology
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Organon GmbH (former name)
Essex Pharma GmbH
  More Information

Responsible Party: Prof. Dr. Klaus Friese, Department of Obstetrics and Gynecology, Campus Grosshadern, LMU
ClinicalTrials.gov Identifier: NCT00805662     History of Changes
Other Study ID Numbers: 355/02
First Submitted: December 5, 2008
First Posted: December 9, 2008
Last Update Posted: December 9, 2008
Last Verified: December 2008

Keywords provided by Ludwig-Maximilians - University of Munich:
IUI
oxytocin

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs