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

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ClinicalTrials.gov Identifier: NCT01111799
Recruitment Status : Unknown
Verified March 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : April 28, 2010
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Infertility Implantation Failure Procedure: endometrial biopsy Procedure: natural cycle + IUI + endometrial biopsy

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Clinical Pregnancy rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Live birth [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

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, Male
Genital Diseases, Female
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators