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Management of Recurrent Implantation Failure (RIF)

Primary Purpose

Recurrent Implantation Failure (RIF)

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Freeze all policy

About this trial

This is an interventional treatment trial for Recurrent Implantation Failure (RIF) focused on measuring Recurrent implantation failure, Freeze all policy, endometrial receptivity, implantation, clinical outcome

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

fresh embryo transfer

Freeze all

Arm Description

Patient with RIF underwent ICSI cycle followed by Day 5 fresh embryo transfer.

Patient with RIF. All of them underwent ICSI cycle, all their embryos were cryopreserved at Day 5 and transferred in a consecutive natural cycle.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

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

Secondary Outcome Measures

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.

Implantation rate

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

Full Information

NCT ID

NCT02681367

First Posted

February 8, 2016

Last Updated

February 9, 2016

Sponsor

TopLab Company for ART Laboratories Consultation and Training

1. Study Identification

Unique Protocol Identification Number

NCT02681367

Brief Title

Management of Recurrent Implantation Failure

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

TopLab Company for ART Laboratories Consultation and Training

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Implantation Failure (RIF)

Keywords

Recurrent implantation failure, Freeze all policy, endometrial receptivity, implantation, clinical outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fresh embryo transfer

Arm Type

No Intervention

Arm Description

Patient with RIF underwent ICSI cycle followed by Day 5 fresh embryo transfer.

Arm Title

Freeze all

Arm Type

Experimental

Arm Description

Patient with RIF. All of them underwent ICSI cycle, all their embryos were cryopreserved at Day 5 and transferred in a consecutive natural cycle.

Intervention Type

Other

Intervention Name(s)

Freeze all policy

Other Intervention Name(s)

Frozen-thawed embryo transfer

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical pregnancy rate

Description

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

Time Frame

4 weeks post embryo transfer

Secondary Outcome Measure Information:

Title

Ongoing pregnancy rate

Description

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.

Time Frame

10 weeks post embryo transfer

Title

Implantation rate

Description

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

Time Frame

6 weeks after embryo transfer

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yasmin Magdi, M.Sc

Organizational Affiliation

Research and development department director at TopLab Company for ART laboratories consultations and training

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

25473625

Citation

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

Results Reference

background

PubMed Identifier

25428436

Citation

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.

Results Reference

result

PubMed Identifier

22976427

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.

Results Reference

result

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Management of Recurrent Implantation Failure

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