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OpenTrials
Completed

NCT Number: NCT02681367

Management of Recurrent Implantation Failure

This is the first study to investigate, whether pregnancy and implantation rates would improve in patients with recurrent implantation failure (RIF), if all embryos were to be frozen and transferred in a consecutive natural cycle.

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Key information

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

There is growing evidence that elective frozen-thawed embryo transfer in a non-stimulated cycle (freeze-all policy) would eliminate the risk of controlled ovarian stimulation and resulting in better endometrial receptivity and lower uterine contractility as compared with fresh intracytoplasmic sperm injection (ICSI) cycles.

RIF refers to women who fail to achieve a clinical pregnancy, in a minimum of three embryo transfer cycles with at least four good-quality embryos were transferred in a woman < 40 years. It affects approximately 10% of ICSI cases. Many management protocols aimed to enhance ICSI outcome in cases of RIF, however, none of them examined the effect of freeze all policy in this category of patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • gonadotropin-releasing hormone agonist and recombinant follicle-stimulating hormone (FSH) in a long protocol cycles;
  • female partners were under age of 40 years;
  • all the patients had a history of recurrent implantation failure i.e: failed to achieve a clinical pregnancy after at least three fresh ICSI cycles where at least 8 good embryos were transferred;
  • their embryos were pushed to Day 5 resulting in blastocysts, and undergo embryo transfer day 5 or vitrification on day 5;
  • endometrial thickness ≥ 7 mm;
  • selected embryos for embryo transfer were blastocysts. -

Exclusion criteria

Couples with testicular or epididymal sperm were excluded.

-

Treatment and study plan

Freeze all policy

Other

Cryopreservation of human blastocysts for freeze all group has been employed using vitrification. The blastocysts were transferred after thawing in a frozen-thawed cycle.

Other names: Frozen-thawed embryo transfer

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 4 weeks post embryo transfer

    Clinical pregnancy was identified by fetal cardiac activity on ultrasound examination 4 weeks after embryo transfer.

Secondary outcomes

  1. Ongoing pregnancy rate

    Time frame: 10 weeks post embryo transfer

    Ongoing pregnancy rate was defined as the number of pregnancies with visible fetal heart motion over the number of transferred embryos at 10 weeks' gestation.

  2. Implantation rate

    Time frame: 6 weeks after embryo transfer

    Implantation rate was defined as the number of intrauterine gestational sacs over the total number of embryos transferred.

Sponsors and collaborators

Lead sponsor

TopLab Company for ART Laboratories Consultation and Training

Other

Registry information

Official study title

The First Study to Compare the Effect of Freeze All Policy Versus Fresh Embryo Transfer After ICSI in Patients With Recurrent Implantation Failure

Acronym: RIF

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2016
Registry last updated
Feb 12, 2016

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.