Management of Recurrent Implantation Failure

Not Applicable

Completed

• Conditions: Recurrent Implantation Failure (RIF)
• Interventions: Other: Freeze all policy

• Registration Number: NCT02681367
• Lead Sponsor: TopLab Company for ART Laboratories Consultation and Training

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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-09
• Last Update Submitted: 2016-02-09
• Study First Posted: 2016-02-12
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	4 weeks post embryo transfer	Clinical pregnancy was identified by fetal cardiac activity on ultrasound examination 4 weeks after embryo transfer.

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	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.
Implantation rate	6 weeks after embryo transfer	Implantation rate was defined as the number of intrauterine gestational sacs over the total number of embryos transferred.