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
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, Male
Genital Diseases, Female
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014