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Nasal Oxcytocin During IUI (Oxy)

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ClinicalTrials.gov Identifier: NCT00805662
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : December 9, 2008
Sponsor:
Collaborators:
Organon GmbH (former name)
Essex Pharma GmbH
Information provided by:
Ludwig-Maximilians - University of Munich

Brief Summary:
Placebo-controlled study. Application of nasal oxytocin (8 IU) during intrauterine insemination in 86 patients.

Condition or disease Intervention/treatment Phase
Idiopathic Infertility Drug: oxytocin, placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Nasal Oxcytocin Fails to Increase Pregnancy Rate of IUI
Study Start Date : May 2003
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Oxytocin
Intranasal oxytocin during IUI
Drug: oxytocin, placebo
intranasal oxytocin during intrauterine insemination
Other Name: Synthocinon



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

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


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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

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

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 Posted: December 9, 2008    Key Record Dates
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