Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF Cycles

Repeated Implantation Failures Clinical Trial

Official title:

The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798862
• Other study ID #: 121212
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 19, 2013
• Last updated: June 8, 2016
• Start date: March 2013
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee of the Attikon University Hospital, Athens
• Study type: Interventional

Clinical Trial Summary

The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients with previous IVF failures.

Description:

Endometrial injury was preformed either through hysteroscope during office hysteroscopy through the non touch technique or through pipelle biopsy in the early follicular phase (days 5 to 9) in the preceding cycle of the IVF treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 42 Years

Eligibility

Inclusion Criteria:

• Personal history of 2 or more failed IVF/ICSI cycles (RIF)

• Age</= 42 years

• Good response with good quality embryos in previous attempts (>2)

Exclusion Criteria:

• Personal history of endometrial tuberculosis/ antituberculous treatment

• Sonographically detected hydrosalpinges

• Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome

• Thrombophilia

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Repeated Implantation Failures

Intervention

Procedure:
• Endometrial injury by hysteroscopy or pipelle sampling

• Proceed to COH directly

Locations

Country	Name	City	State
Greece	Assisted Reproduction Unit	Alexandroupolis	Thrace
Greece	Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (5)

Baum M, Yerushalmi GM, Maman E, Kedem A, Machtinger R, Hourvitz A, Dor J. Does local injury to the endometrium before IVF cycle really affect treatment outcome? Results of a randomized placebo controlled trial. Gynecol Endocrinol. 2012 Dec;28(12):933-6. doi: 10.3109/09513590.2011.650750. Epub 2012 Sep 3. — View Citation

El-Toukhy T, Sunkara S, Khalaf Y. Local endometrial injury and IVF outcome: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Oct;25(4):345-54. doi: 10.1016/j.rbmo.2012.06.012. Epub 2012 Jun 26. Review. — View Citation

Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J — View Citation

Narvekar SA, Gupta N, Shetty N, Kottur A, Srinivas M, Rao KA. Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study. J Hum — View Citation

Potdar N, Gelbaya T, Nardo LG. Endometrial injury to overcome recurrent embryo implantation failure: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Dec;25(6):561-71. doi: 10.1016/j.rbmo.2012.08.005. Epub 2012 Sep 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive bHCG rate		through study completion, an average of 2 years	No
Secondary	clinical pregnancy rate		2 years	No
Secondary	live birth rate		2 years	Yes
Secondary	Ectopic pregnancy rate		2 years	Yes
Secondary	Miscarriage rate		2 years	Yes
Secondary	Ongoing pregnancy rate		2 years	Yes
Secondary	Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA)		2 years	Yes