Does Endometrial Injury Improve Intrauterine Insemination Outcome?

NCT ID: NCT02542280

Last Updated: 2016-01-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-09-30

Brief Summary

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The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.

Detailed Description

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In a selected group of patients with repeated implantation failure, endometrial injury in the preceding cycle may improve ICSI outcome.

Little is known about the efficacy of this procedure in improving intrauterine insemination outcome.

Also little is known about the effect of this procedure if done in the stimulation cycle weather in ICSI or intrauterine insemination cycles.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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endometrial injury

Endometrial injury during ovarian stimulation combined with intrauterine insemination.

Group Type EXPERIMENTAL

endometrial injury.

Intervention Type PROCEDURE

Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.

intrauterine insemination

Intervention Type PROCEDURE

Placement of washed sperm in the uterus using a catheter, around the time of ovulation.

ovarian stimulation

Intervention Type DRUG

Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.

no endometrial injury

Ovarian stimulation combined with intrauterine insemination.

Group Type ACTIVE_COMPARATOR

intrauterine insemination

Intervention Type PROCEDURE

Placement of washed sperm in the uterus using a catheter, around the time of ovulation.

ovarian stimulation

Intervention Type DRUG

Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.

Interventions

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endometrial injury.

Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.

Intervention Type PROCEDURE

intrauterine insemination

Placement of washed sperm in the uterus using a catheter, around the time of ovulation.

Intervention Type PROCEDURE

ovarian stimulation

Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.

Intervention Type DRUG

Other Intervention Names

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endometrial scratch. endometrial sample. artificial insemination controlled ovarian hyperstimulatiom

Eligibility Criteria

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Inclusion Criteria

* 18 - 38 years.
* patent fallopian tunes.
* mild male factor.
* anovulation.
* unexplained infertility.

Exclusion Criteria

* indications for ICSI.
* evidence of pelvic inflammatory disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Bahaa Eldin Ahmed

lesturer in Obstetrics and Gynecology.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Bahaa

Role: PRINCIPAL_INVESTIGATOR

Lecturer in Obstetrics and Gynecology, faculty of medicine, Ain Shams University.

Other Identifiers

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abahaa050301

Identifier Type: -

Identifier Source: org_study_id

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