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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00993902
First Posted: October 14, 2009
Last Update Posted: October 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Baskent University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Baskent University:

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

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

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

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 Submitted: July 22, 2009
First Posted: October 14, 2009
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


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