Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by McGill University Health Center. Recruitment status was Recruiting

First Received on August 18, 2008. Last Updated on October 14, 2009 History of Changes

Sponsor:	McGill University Health Center
Information provided by:	McGill University Health Center
ClinicalTrials.gov Identifier:	NCT00737984

Purpose

Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles

Condition	Intervention
Infertility Clinical Pregnancy Rate	Procedure: Endometrial sampling

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination

Resource links provided by NLM:

MedlinePlus related topics: Infertility

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:

The rate of clinical pregnancy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	162
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 Group 1 patients will receive standard superovulation-IUI treatment without endometrial sampling
Active Comparator: 2 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	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 Other Names: Endometrial sampling Intrauterine insemination Clinical pregnancy rate

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737984

Contacts

Contact: Togas Tulandi, MD, MHCM

togas.tulandi@mcgill.ca

Locations

Canada, Quebec
McGill University Health Center	Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Togas Tulandi, MD, MHCM togas.tulandi@mcgill.ca
Principal Investigator: Togas Tulandi, MD, MHCM
Sub-Investigator: Mohammed Agdi, MD

Sponsors and Collaborators

McGill University Health Center

Investigators

Principal Investigator:

Togas Tulandi, MD, MHCM

McGill University Health Center

More Information

Publications:

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.

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.

Responsible Party:	Togas Tulandi, MD, MHCM, McGill University health center
ClinicalTrials.gov Identifier:	NCT00737984 History of Changes
Other Study ID Numbers:	SDR-08-004
Study First Received:	August 18, 2008
Last Updated:	October 14, 2009
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:

Infertility
Clinical pregnancy rate

Additional relevant MeSH terms:

Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012