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

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ClinicalTrials.gov Identifier: NCT00993902
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : October 14, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Infertility Procedure: Intrauterine insemination (single) Procedure: Double intrauterine insemination Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2008
Primary Completion Date : May 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. ongoing pregnancy rates [ Time Frame: pregnancy >12 weeks of gestation ]

Secondary Outcome Measures :
  1. The effects of different coh regimens on outcomes [ Time Frame: 14 days after IUI procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 37 Years   (Adult)
Sexes 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

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): 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

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
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

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

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