NCT01278706

Brief Summary

Endometrial biopsy has been shown to improve IVF pregnancy and live birth rates. The optimal time of performing the biopsy is yet to be established. In this study, the investigators will compare different temporal timing of the biopsies with regards to the menstrual cycle and their affect on the success rates of the treatment.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Last Updated

January 26, 2011

Status Verified

December 1, 2010

Enrollment Period

2 years

First QC Date

January 18, 2011

Last Update Submit

January 25, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • pregnancy rates

    2 years

Secondary Outcomes (1)

  • live birth rates

    3 years

Study Arms (4)

no treatment

NO INTERVENTION

one biopsy, proliferative phase

EXPERIMENTAL
Procedure: endometrial biopsy/ies

one biopsy, secretory phase

EXPERIMENTAL
Procedure: endometrial biopsy/ies

two biopsies

EXPERIMENTAL
Procedure: endometrial biopsy/ies

Interventions

performing office endometrial biopsy with a disposable sterile catheter

one biopsy, proliferative phaseone biopsy, secretory phasetwo biopsies

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal menstrual cycle
  • between 1-6 previous failed IVF cycles
  • normal hormonal profile

You may not qualify if:

  • intrauterine procedure in last 3 months
  • hydrosalpinx
  • intrauterine lesion /malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaplan Medical Center, IVF Unit

Rehovot, Israel

Location

Weizmann Institute of Science

Rehovot, Israel

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Dan Levin, M.D.

CONTACT

Irit Granot, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Last Updated

January 26, 2011

Record last verified: 2010-12

Locations