Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination

Infertility Clinical Trial

Official title:

Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00737984
• Other study ID #: SDR-08-004
• 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 Then, the piston is withdrawn to create negative suction and gentle movement of Pipelle up and down in the uterine cavity is performed while it is against the uterine wall. The Pipelle catheter is withdrawn gently and any obtained specimen will be sent for histopathological examination.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

• Clinical Pregnancy Rate
• Infertility

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