Does Local Injury of the Endometrium Improve Controlled Ovarian Hyperstimulation (COH) + Intrauterine Insemination (IUI) Outcome?

NCT ID: NCT01111799

Last Updated: 2012-03-16

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-10-31

Brief Summary

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It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the rates of implantation and pregnancy. The hypothesis of our present study is that the endometrial injury procedure will have the same beneficial effect in patients undergoing controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).

Detailed Description

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In order to test our hypothesis, we will perform the simple procedure of local injury of the endometrium using a "Pipelle" biopsy catheter during the spontaneous menstrual cycle that precedes a COH + IUI treatment.

Conditions

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Infertility Implantation Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clomiphene citrate + IUI + endometrial biopsy

Clomiphene citrate + IUI + endometrial biopsy

Group Type EXPERIMENTAL

endometrial biopsy

Intervention Type PROCEDURE

two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.

Clomiphene citrate + IUI

Group Type NO_INTERVENTION

No interventions assigned to this group

gonadotrophines + IUI + endometrial biopsy

two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.

Group Type EXPERIMENTAL

endometrial biopsy

Intervention Type PROCEDURE

two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.

gonadotrophines + IUI

Group Type NO_INTERVENTION

No interventions assigned to this group

natural cycle + IUI + endometrail biopsy

two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.

Group Type EXPERIMENTAL

natural cycle + IUI + endometrial biopsy

Intervention Type PROCEDURE

two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.

natural cycle + IUI

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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endometrial biopsy

two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.

Intervention Type PROCEDURE

endometrial biopsy

two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.

Intervention Type PROCEDURE

natural cycle + IUI + endometrial biopsy

two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age 18-38.
* infertility.
* patients undergoing IUI treatment.
* at least one failed IUI cycle.

Exclusion Criteria

* indication for IVF treatment.
* Known Pelvic inflammatory disease(PID).
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuval Or, MD

Role: STUDY_DIRECTOR

Clalit health service

Locations

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Remez women medical center

Rehovot, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yuval Or, MD

Role: CONTACT

+97289445150

Leila Aliger, MD

Role: CONTACT

+97289445150

Facility Contacts

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Yuval Or, MD

Role: primary

+97289445150

Ayelet Mokasey

Role: backup

+97589445150

References

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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 BACKGROUND
PMID: 12798877 (View on PubMed)

Other Identifiers

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004608K

Identifier Type: -

Identifier Source: org_study_id

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