Management of Recurrent Implantation Failure

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recurrent Implantation Failure (RIF)

Intervention / Treatment
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* Other: Freeze all policy


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: fresh embryo transfer<br>Patient with RIF underwent ICSI cycle followed by Day 5 fresh embryo transfer. | |
| Experimental: Freeze all<br>Patient with RIF. All of them underwent ICSI cycle, all their embryos were cryopreserved at Day 5 and transferred in a consecutive natural cycle. | Other: Freeze all policy<br>* Cryopreservation of human blastocysts for freeze all group has been employed using vitrification. The blastocysts were transferred after thawing in a frozen-thawed cycle.<br>* Other names: Frozen-thawed embryo transfer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent implantation failure, Freeze all policy, endometrial receptivity, implantation, clinical outcome