Endometrial Scratching in Couples With Unexplained Subfertility

NCT ID: NCT01412606

Last Updated: 2012-08-30

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-06-30

Brief Summary

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Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase pregnancy rate in women with unexplained infertility.

Detailed Description

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Conditions

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Subfertility

Keywords

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Unexplained infertility-endometrial scratching effect of endometrial biopsy (scratching) on clinical pregnancy rates in women with unexplained infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Scrathcing

scratching of endometrium on day 21-26 of a spontaneous menstrual cycle

Group Type EXPERIMENTAL

scratching

Intervention Type PROCEDURE

scratching endometrium on day 21-26 of a spontaneous menstrual cycle

Control

Uterine sounding on day 21-26 of a spontaneous menstrual cycle

Group Type PLACEBO_COMPARATOR

scratching

Intervention Type PROCEDURE

scratching endometrium on day 21-26 of a spontaneous menstrual cycle

Interventions

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scratching

scratching endometrium on day 21-26 of a spontaneous menstrual cycle

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* women aged between 20 and 39 years with at least one year of infertility
* regular menstruation with the length of the cycle between 22-34 days and ovulation confirmed by appropriately timed mid-luteal progesterone
* fertile semen variables
* bilateral tubal patency (demonstrated by laparoscopy or hysterosalpingography).
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Gibreel

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Gibreel, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura University Teaching Hospital Gynecology outpatient clinic

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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Gibreel A, Badawy A, El-Refai W, El-Adawi N. Endometrial scratching to improve pregnancy rate in couples with unexplained subfertility: a randomized controlled trial. J Obstet Gynaecol Res. 2013 Mar;39(3):680-4. doi: 10.1111/j.1447-0756.2012.02016.x. Epub 2012 Oct 29.

Reference Type DERIVED
PMID: 23106834 (View on PubMed)

Other Identifiers

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AG2

Identifier Type: -

Identifier Source: org_study_id