Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination

This study has been terminated.
(Because very low number of patients were enrolled)
Sponsor:
Information provided by (Responsible Party):
Mohammed Agdi, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00737984
First received: August 18, 2008
Last updated: April 19, 2012
Last verified: October 2009
  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:


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 ]

Enrollment: 9
Study Start Date: August 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (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 Then, the piston is withdrawn to create negative suction and gentle movement of Pipelle up and down in the uterine cavity is performed while it is against the uterine wall.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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Togas Tulandi, MD, MHCM McGill University Health Center
  More Information

Publications:
Responsible Party: Mohammed Agdi, Consultant Reproductive Endocrinology and Infertility, 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: April 19, 2012
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 August 01, 2014