NCT01412606

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

August 8, 2011

Last Update Submit

August 28, 2012

Conditions

Subfertility

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    6 months

Secondary Outcomes (1)

  • miscarriage rate

    6 months

Study Arms (2)

Scrathcing

EXPERIMENTAL

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

Procedure: scratching

Control

PLACEBO COMPARATOR

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

Procedure: scratching

Interventions

scratchingPROCEDURE

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

ControlScrathcing

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Teaching Hospital Gynecology outpatient clinic

Al Mansurah, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 23106834DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ahmed Gibreel, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 9, 2011

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

August 30, 2012

Record last verified: 2012-08

Locations

EG(1)