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Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development

This study has been completed.
Sponsor:
Information provided by:
Baskent University
ClinicalTrials.gov Identifier:
NCT00993902
First received: July 22, 2009
Last updated: October 13, 2009
Last verified: October 2009
History of Changes
  Purpose

Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (>16mm).


Condition Intervention Phase
Infertility
 Procedure: Intrauterine insemination (single)
Procedure: Double intrauterine insemination
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Baskent University:

Primary Outcome Measures:
  • ongoing pregnancy rates [ Time Frame: pregnancy >12 weeks of gestation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The effects of different coh regimens on outcomes [ Time Frame: 14 days after IUI procedure ] [ Designated as safety issue: Yes ]

Enrollment: 228
Study Start Date: May 2008
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Single IUI
Single IUI will be carried on after 36-38 hours of HCG administration
 Procedure: Intrauterine insemination (single)
Single IUI after 36-38 hours of HCG
Other Name: Group I
Active Comparator: Double IUI Procedure: Double intrauterine insemination
Double insemination after 18 and 40 hours of HCG administration.
Other Name: Grup II

Detailed Description:

Metaanalysis for the effects of double IUI demonstrates that effects of this procedure is not different from single IUI. It is known that nearly 25% of coh cycles is evident by monofollicular development.For this reason it is possible that this monofollicular cycles in the studies could decrease the effects of double IUI.

Inclusion criteria:

  1. Patients with unexplained infertility or mild male factor infertility whom admitted to the COH+IUI programme in our infertility unit.
  2. Female age <37 years old.
  3. Baseline FSH <12 mIU/L
  4. Total antral follicle count>6
  5. During the first three cycles of COH+IUI
  6. Minimum 2 follicles >16 mm at the day of HCG.

Primary outcome:

Ongoing pregnancy rates

Secondary outcomes:

The effects of different coh regimens (CC,FSH,CC+FSH)on the outcomes.

  Eligibility

Ages Eligible for Study:   20 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unexplained and mild male factor infertile patients
  • Minimum 2 follicles >16 mm at the day of HCG
  • First 3 cycles

Exclusion Criteria:

  • Basal FSH >12 mIU/L
  • Total antral follicle count<6
  • Severe male factor infertility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993902

Locations
Turkey
Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit
Adana, Turkey, 01120
Sponsors and Collaborators
Baskent University
  More Information

No publications provided by Baskent University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Associated Prof.Tayfun Bagis, MD
ClinicalTrials.gov Identifier: NCT00993902     History of Changes
Other Study ID Numbers: BU1
Study First Received: July 22, 2009
Last Updated: October 13, 2009
Health Authority: Turkey: Ministry of Health

Keywords provided by Baskent University:
Double IUI
Intrauterine insemination
Unexplained infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013