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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00737984
Other study ID # SDR-08-004
Secondary ID
Status Terminated
Phase N/A
First received August 18, 2008
Last updated April 19, 2012
Start date August 2008
Est. completion date August 2011

Study information

Verified date October 2009
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles


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 Then, the piston is withdrawn to create negative suction and gentle movement of Pipelle up and down in the uterine cavity is performed while it is against the uterine wall. The Pipelle catheter is withdrawn gently and any obtained specimen will be sent for histopathological examination.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Endometrial sampling
Endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle

Locations

Country Name City State
Canada McGill University Health Center Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of clinical pregnancy 24 months Yes
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