Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination

NCT ID: NCT00737984

Last Updated: 2012-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-08-31

Brief Summary

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Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles

Detailed Description

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 Then, the piston is withdrawn to create negative suction and gentle movement of Pipelle up and down in the uterine cavity is performed while it is against the uterine wall. The Pipelle catheter is withdrawn gently and any obtained specimen will be sent for histopathological examination.

Conditions

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Infertility Clinical Pregnancy Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

Endometrial sampling

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Intrauterine insemination Clinical pregnancy rate

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Agdi

Consultant Reproductive Endocrinology and Infertility

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Togas Tulandi, MD, MHCM

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

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McGill University Health Center

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 17197286 (View on PubMed)

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.

Reference Type RESULT
PMID: 12798877 (View on PubMed)

Other Identifiers

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SDR-08-004

Identifier Type: -

Identifier Source: org_study_id

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