NCT02761278

Brief Summary

The aim of this study is to measure the expression of HOXA10 and HOXA11 in the endometrium of infertility patients with an endometrial polyp before and after polypectomy. HOXA10 and HOXA11 are well-established markers of implantation. It is uncertain as to whether an endometrial polyp interferes with embryo implantation. A higher expression of HOXA10 and HOXA11 after polypectomy can indicate that endometrial polyp does interfere with embryo implantation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 2, 2016

Last Update Submit

May 11, 2016

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Comparison of amounts of HOXA10 and HOXA11 expressed before and after polypectomy

    Four months

Study Arms (2)

HOXA10 and HOXA11 Expression Before Polypectomy

ACTIVE COMPARATOR

A biopsy will taken in infertility patients with endometrial polyp before polypectomy

Procedure: Endometrial biopsy

HOXA10 and HOXA11 Expression After Polypectomy

ACTIVE COMPARATOR

A biopsy will taken in infertility patients with endometrial polyp 1-3 months after polypectomy

Procedure: Endometrial biopsy

Interventions

Endometrial biopsyPROCEDURE
HOXA10 and HOXA11 Expression After PolypectomyHOXA10 and HOXA11 Expression Before Polypectomy

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile women with endometrial polyp

You may not qualify if:

  • Endometriosis
  • Polycystic ovary syndrome
  • Hydrosalpinx
  • Sub-mucus myoma
  • Women who have taken hormonal therapy in the preceding month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Guy Shrem, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Shrem, MD

CONTACT

dr.shremguy@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 4, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

May 12, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share