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Does Local Injury of the Endometrium Improve Controlled Ovarian Hyperstimulation (COH) + Intrauterine Insemination (IUI) Outcome?

This study is currently recruiting participants.
Verified March 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01111799
First received: April 21, 2010
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the rates of implantation and pregnancy. The hypothesis of our present study is that the endometrial injury procedure will have the same beneficial effect in patients undergoing controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).


Condition Intervention
Infertility
Implantation Failure
 Procedure: endometrial biopsy
Procedure: natural cycle + IUI + endometrial biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploration of the Possibility That Local Injury of the Endometrium Has the Same Beneficial Effect on IUI Outcome as Demonstrated in IVF Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Clinical Pregnancy rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Live birth [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: June 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clomiphene citrate + IUI + endometrial biopsy
Clomiphene citrate + IUI + endometrial biopsy
 Procedure: endometrial biopsy
two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
No Intervention: Clomiphene citrate + IUI
Experimental: gonadotrophines + IUI + endometrial biopsy
two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
 Procedure: endometrial biopsy
two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
No Intervention: gonadotrophines + IUI
Experimental: natural cycle + IUI + endometrail biopsy
two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
 Procedure: natural cycle + IUI + endometrial biopsy
two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
No Intervention: natural cycle + IUI

Detailed Description:

In order to test our hypothesis, we will perform the simple procedure of local injury of the endometrium using a "Pipelle" biopsy catheter during the spontaneous menstrual cycle that precedes a COH + IUI treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-38.
  • infertility.
  • patients undergoing IUI treatment.
  • at least one failed IUI cycle.

Exclusion Criteria:

  • indication for IVF treatment.
  • Known Pelvic inflammatory disease(PID).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111799

Contacts
Contact: Yuval Or, MD +97289445150 yuval_o@clalit.org.il
Contact: Leila Aliger, MD +97289445150

Locations
Israel
Remez women medical center Recruiting
Rehovot, Israel
Contact: Yuval Or, MD     +97289445150     yuval_o@clalit.org.il    
Contact: Ayelet Mokasey     +97589445150     ayeletmo@clalit.org.il    
Principal Investigator: Yuval Or, MD            
Sponsors and Collaborators
Meir Medical Center
Investigators
Study Director: Yuval Or, MD Clalit health service
  More Information

Publications:

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01111799     History of Changes
Other Study ID Numbers: 004608K
Study First Received: April 21, 2010
Last Updated: March 15, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
endometrial biopsy
implantation
uterine receptivity
 infertility
controled ovarian hyperstimulation
intra uterine insemination

Additional relevant MeSH terms:
Infertility
Ovarian Hyperstimulation Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Clomiphene
Estrogen Antagonists
 Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on May 22, 2013