NCT00805662

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
Last Updated

December 9, 2008

Status Verified

December 1, 2008

Enrollment Period

4.7 years

First QC Date

December 5, 2008

Last Update Submit

December 8, 2008

Conditions

Idiopathic Infertility

Keywords

IUIoxytocin

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    1 month

Secondary Outcomes (1)

  • Possible side effects: nasal mucosal irritation, headake, lower abdominal pain

    10 minutes

Study Arms (1)

Oxytocin

EXPERIMENTAL

Intranasal oxytocin during IUI

Drug: oxytocin, placebo

Interventions

oxytocin, placeboDRUG

intranasal oxytocin during intrauterine insemination

Also known as: Synthocinon
Oxytocin

Eligibility Criteria

Age18 Years - 43 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Obstetrics and Gynecology

Munich, 81377, Germany

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 9, 2008

Study Start

May 1, 2003

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

December 9, 2008

Record last verified: 2008-12

Locations

DE(1)