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

National and Kapodistrian University of Athens

Status and phase: Completed; Phase 3; Phase 2

Conditions: Repeated Implantation Failures

Treatments: Procedure: Endometrial injury by hysteroscopy or pipelle sampling; Procedure: Proceed to COH directly

Study type: Interventional

Funder types: Other

Identifiers

NCT01798862

121212

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 25 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Endometrial injury by hysteroscopy or pipelle sapling

Experimental group

Description:

Endometrial Sampling by pipelle or hysteroscopy performed once between 6th to 10th day in the cycle prior to the fresh IVF/ ICSI cycle.

Treatment:

Procedure: Endometrial injury by hysteroscopy or pipelle sampling

COH for IVF without hysteroscopy or pipelle sampling

Active Comparator group

Description:

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.

Treatment:

Procedure: Proceed to COH directly