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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Intrauterine insemination (single)
Double intrauterine insemination
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Double IUI, Intrauterine insemination, Unexplained infertility

Eligibility Criteria

20 Years - 37 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Single IUI

Double IUI

Arm Description

Single IUI will be carried on after 36-38 hours of HCG administration

Outcomes

Primary Outcome Measures

ongoing pregnancy rates

Secondary Outcome Measures

The effects of different coh regimens on outcomes

Full Information

First Posted
July 22, 2009
Last Updated
October 13, 2009
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT00993902
Brief Title
Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Baskent University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (>16mm).
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: Patients with unexplained infertility or mild male factor infertility whom admitted to the COH+IUI programme in our infertility unit. Female age <37 years old. Baseline FSH <12 mIU/L Total antral follicle count>6 During the first three cycles of COH+IUI 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Double IUI, Intrauterine insemination, Unexplained infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single IUI
Arm Type
Sham Comparator
Arm Description
Single IUI will be carried on after 36-38 hours of HCG administration
Arm Title
Double IUI
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Intrauterine insemination (single)
Other Intervention Name(s)
Group I
Intervention Description
Single IUI after 36-38 hours of HCG
Intervention Type
Procedure
Intervention Name(s)
Double intrauterine insemination
Other Intervention Name(s)
Grup II
Intervention Description
Double insemination after 18 and 40 hours of HCG administration.
Primary Outcome Measure Information:
Title
ongoing pregnancy rates
Time Frame
pregnancy >12 weeks of gestation
Secondary Outcome Measure Information:
Title
The effects of different coh regimens on outcomes
Time Frame
14 days after IUI procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit
City
Adana
ZIP/Postal Code
01120
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
20457669
Citation
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.
Results Reference
derived

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

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