Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Nasal Oxcytocin During IUI (Oxy)

This study has been completed.
Sponsor:
Collaborators:
Organon GmbH (former name)
Essex Pharma GmbH
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00805662
First received: December 5, 2008
Last updated: December 8, 2008
Last verified: December 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 5, 2008
Last Updated: December 8, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on November 20, 2014