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

July 22, 2009
October 13, 2009
May 2008
May 2009   (final data collection date for primary outcome measure)
ongoing pregnancy rates [ Time Frame: pregnancy >12 weeks of gestation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00993902 on ClinicalTrials.gov Archive Site
The effects of different coh regimens on outcomes [ Time Frame: 14 days after IUI procedure ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development
Not Provided

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
  • Procedure: Intrauterine insemination (single)
    Single IUI after 36-38 hours of HCG
    Other Name: Group I
  • Procedure: Double intrauterine insemination
    Double insemination after 18 and 40 hours of HCG administration.
    Other Name: Grup II
  • Sham Comparator: Single IUI
    Single IUI will be carried on after 36-38 hours of HCG administration
    Intervention: Procedure: Intrauterine insemination (single)
  • Active Comparator: Double IUI
    Intervention: Procedure: Double intrauterine insemination
Bagis T, Haydardedeoglu B, Kilicdag EB, Cok T, Simsek E, Parlakgumus AH. Single versus double intrauterine insemination in multi-follicular ovarian hyperstimulation cycles: a randomized trial. Hum Reprod. 2010 Jul;25(7):1684-90. doi: 10.1093/humrep/deq112. Epub 2010 May 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
July 2009
May 2009   (final data collection date for primary outcome measure)

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
Female
20 Years to 37 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00993902
BU1
No
Associated Prof.Tayfun Bagis, MD
Baskent University
Not Provided
Not Provided
Baskent University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP