Management of Recurrent Implantation Failure

Recurrent Implantation Failure (RIF) Clinical Trial

— RIF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681367
• Other study ID #: #001008
• Status: Completed
• Phase: N/A
• First received: February 8, 2016
• Last updated: February 9, 2016
• Start date: February 2012
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: TopLab Company for ART Laboratories Consultation and Training
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

1. gonadotropin-releasing hormone agonist and recombinant follicle-stimulating hormone (FSH) in a long protocol cycles;

2. female partners were under age of 40 years;

3. 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;

4. their embryos were pushed to Day 5 resulting in blastocysts, and undergo embryo transfer day 5 or vitrification on day 5;

5. endometrial thickness = 7 mm;

6. selected embryos for embryo transfer were blastocysts. -

Exclusion Criteria:

Couples with testicular or epididymal sperm were excluded.

Related Conditions & MeSH terms

• Recurrent Implantation Failure (RIF)

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TopLab Company for ART Laboratories Consultation and Training

References & Publications (3)

Roque M. Freeze-all policy: is it time for that? J Assist Reprod Genet. 2015 Feb;32(2):171-6. doi: 10.1007/s10815-014-0391-0. Epub 2014 Nov 27. Review. — View Citation

Simon A, Laufer N. Assessment and treatment of repeated implantation failure (RIF). J Assist Reprod Genet. 2012 Nov;29(11):1227-39. doi: 10.1007/s10815-012-9861-4. Epub 2012 Sep 14. Review. — View Citation

Timeva T, Shterev A, Kyurkchiev S. Recurrent implantation failure: the role of the endometrium. J Reprod Infertil. 2014 Oct;15(4):173-83. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Clinical pregnancy was identified by fetal cardiac activity on ultrasound examination 4 weeks after embryo transfer.	4 weeks post embryo transfer
Secondary	Ongoing pregnancy rate	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.	10 weeks post embryo transfer
Secondary	Implantation rate	Implantation rate was defined as the number of intrauterine gestational sacs over the total number of embryos transferred.	6 weeks after embryo transfer

External Links

•   fresh vs. frozen-thawed embryo transfer