Clinical trial NCT02681367: Management of Recurrent Implantation Failure
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
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Implantation Failure (RIF)
Keywords: Recurrent implantation failure
Freeze all policy
endometrial receptivity
implantation
clinical outcome
Lead sponsor: TopLab Company for ART Laboratories Consultation and Training
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 4 weeks post embryo transfer
Secondary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 10 weeks post embryo transfer
measure: Implantation rate
timeFrame: 6 weeks after embryo transfer
Other outcomes:
Locations:
Study officials:
affiliation: Research and development department director at TopLab Company for ART laboratories consultations and training
name: Yasmin Magdi, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Timeva T, Shterev A, Kyurkchiev S. Recurrent implantation failure: the role of the endometrium. J Reprod Infertil. 2014 Oct;15(4):173-83.
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.
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.