This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Nasal Oxcytocin During IUI (Oxy)

This study has been completed.
Organon GmbH (former name)
Essex Pharma GmbH
Information provided by:
Ludwig-Maximilians - University of Munich Identifier:
First received: December 5, 2008
Last updated: December 8, 2008
Last verified: December 2008
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00805662

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 Identifier: NCT00805662     History of Changes
Other Study ID Numbers: 355/02
Study First Received: December 5, 2008
Last Updated: December 8, 2008

Keywords provided by Ludwig-Maximilians - University of Munich:

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Reproductive Control Agents
Physiological Effects of Drugs processed this record on September 25, 2017