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Completed

NCT Number: NCT04597463

The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of RIF

The investigators checked the hypothesis whether endometrial injury performed during the cycle before a frozen embryo transfer in women with RIF can improve pregnancy rates

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Key information

Conditions

Endometrial Injury Hysteroscopy Repeated Implantation Failures

Age range

25 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National and Kapodistrian University of Athens

Athens, Greece

About this study

After a freeze all cycle, participants were divided in two groups: an intervention group (n=30), who underwent endometrial injury before the transfer, and a control group (n=30), who underwent no other intervention. The primary outcome was clinical pregnancy rate, while secondary clinical and laboratory parameters. Baseline and cycle characteristics were also compared between groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with RIF under 42 years old
  • BMI 20-30
  • Normal endometrial cavity
  • FSH <15 IU/L
  • Absence of immunological or hematological disorder

Exclusion criteria

  • women over 42 years old
  • FSH>15 IU/L
  • women with chronic immunological or hematological disorder
  • stage III or IV of endometriosis
  • women with pathology concerning the endometrial cavity
  • women with a medical history of adnexectomy or oophorectomy

Treatment and study plan

Endometrial injury

Procedure

Endometrial injury was performed hysteroscopically after freeze all cycles and during the cycle before the frozen embryo transfer

Primary outcomes

  1. Physiological parameter - Live birth rate

    Time frame: 22 weeks

    The complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age

Secondary outcomes

  1. Physiological parameter -Clinical pregnancy rate

    Time frame: 7 weeks

    A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy

  2. Adverse event - Miscarriage

    Time frame: 22 weeks

    Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

The Combination of Endometrial Injury and Freeze All Strategy in Women With a History of Repeated Implantation Failure.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2020
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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