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

Phase 2

Completed

• Conditions: Repeated Implantation Failures
• Interventions: Procedure: Endometrial injury by hysteroscopy or pipelle sampling; Procedure: Proceed to COH directly

• Registration Number: NCT01798862
• Lead Sponsor: National and Kapodistrian University of Athens

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-22
• Study First Posted: 2013-02-26
• Study Start: 2013-03
• Primary Completion: 2016-05
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endometrial injury by hysteroscopy or pipelle sapling	Endometrial injury by hysteroscopy or pipelle sampling	Endometrial Sampling by pipelle or hysteroscopy performed once between 6th to 10th day in the cycle prior to the fresh IVF/ ICSI cycle.
COH for IVF without hysteroscopy or pipelle sampling	Proceed to COH directly	Procedure: COH for IVF Both GnRH agonists (long, starting at day 2 or 21) with triptorelin acetate 0.1 mg (Gonapeptyl daily) and antagonists with ganirelix 0.25mg (Orgalutran) or cetrorelix 0.25mg (Cetrotide) protocols will be used; for ovarian stimulation both recombinant FSH ( Puregon) and human menopausal gonadotrophin ( Menopur) will be used. Ovarian response will be monitored by ultrasonography, oocyte retrieval will be performed 36-38 hours after the Hcg triggering and for luteal phase support 600 mg progesterone tablets ( Utrogestan) will be applied.

Primary Outcome Measures

Name	Time	Method
positive bHCG rate	through study completion, an average of 2 years

Secondary Outcome Measures

Name	Time	Method
live birth rate	2 years
clinical pregnancy rate	2 years
Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA)	2 years
Ectopic pregnancy rate	2 years
Miscarriage rate	2 years
Ongoing pregnancy rate	2 years

Trial Locations

Locations (2)

Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital; 🇬🇷 Athens, Attica, Greece

Assisted Reproduction Unit; 🇬🇷 Alexandroupolis, Thrace, Greece