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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Genital Diseases, Female
Genital Diseases, Male
Clomiphene
Enclomiphene
Zuclomiphene
Estrogen Antagonists
Estrogen Receptor Modulators
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014