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

October 13, 2009 updated by: Baskent University
Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (>16mm).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

228

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01120
        • Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Group I
Active Comparator: Double IUI
Procedure: Double intrauterine insemination
Double insemination after 18 and 40 hours of HCG administration.
Other Names:
  • Grup II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ongoing pregnancy rates
Time Frame: pregnancy >12 weeks of gestation
pregnancy >12 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
The effects of different coh regimens on outcomes
Time Frame: 14 days after IUI procedure
14 days after IUI procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2009

Last Update Submitted That Met QC Criteria

October 13, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BU1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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