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Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination

Primary Purpose

Infertility, Clinical Pregnancy Rate

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Endometrial sampling
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, Clinical pregnancy rate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. All women undergoing superovulation with gonadotrophins and intrauterine insemination.
  2. All women with cervical factor, mild male factor and/or unexplained infertility.
  3. At least one patent Fallopian tube.

Exclusion Criteria:

  1. Bilateral tubal disease
  2. Severe male factor infertility
  3. Intrauterine pathology (submucosal fibroid, endometrial polyp, adhesions)
  4. Women with positive cervical culture and/or acute vaginal infection

Sites / Locations

  • McGill University Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

Group 1 patients will receive standard superovulation-IUI treatment without endometrial sampling

Group 2 patients will receive standard superovulation-IUI treatment with endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle

Outcomes

Primary Outcome Measures

The rate of clinical pregnancy

Secondary Outcome Measures

Full Information

First Posted
August 18, 2008
Last Updated
April 19, 2012
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00737984
Brief Title
Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination
Official Title
Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Why Stopped
Because very low number of patients were enrolled
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles
Detailed Description
Endometrial sampling is performed using the standard technique in the outpatient department. Similarly, superovulation with gonadotrophins will be performed according to our standard practice.Endometrial sampling will be done in the follicular phase not later than day 10 of the cycle. Endometrial sampling will be performed using Pipelle sampling catheter. The Pipelle is inserted gently through the cervical canal into the uterine cavity and advanced slowly till just resistance felt by the operator. Then, the piston is withdrawn to create negative suction and gentle movement of Pipelle up and down in the uterine cavity is performed while it is against the uterine wall. The Pipelle catheter is withdrawn gently and any obtained specimen will be sent for histopathological examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Clinical Pregnancy Rate
Keywords
Infertility, Clinical pregnancy rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Group 1 patients will receive standard superovulation-IUI treatment without endometrial sampling
Arm Title
2
Arm Type
Active Comparator
Arm Description
Group 2 patients will receive standard superovulation-IUI treatment with endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle
Intervention Type
Procedure
Intervention Name(s)
Endometrial sampling
Other Intervention Name(s)
Intrauterine insemination, Clinical pregnancy rate
Intervention Description
Endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle
Primary Outcome Measure Information:
Title
The rate of clinical pregnancy
Time Frame
24 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All women undergoing superovulation with gonadotrophins and intrauterine insemination. All women with cervical factor, mild male factor and/or unexplained infertility. At least one patent Fallopian tube. Exclusion Criteria: Bilateral tubal disease Severe male factor infertility Intrauterine pathology (submucosal fibroid, endometrial polyp, adhesions) Women with positive cervical culture and/or acute vaginal infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Togas Tulandi, MD, MHCM
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17197286
Citation
Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.
Results Reference
background
PubMed Identifier
12798877
Citation
Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
Results Reference
result

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Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination

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