Optimal Embryonic Stage for Transfer in Poor Responders

Study Overview
=================
Brief Summary
-----------------
A Prospective cohort study including couples with poor responder females who undergoing ICSI

Detailed Description
-----------------
Purpose: To determine the optimal embryonic stage for transfer in poor responders. Method: Patients were divided into day 3 transfer group and day 5 transfer group. All cases had the same stimulation protocol and planning to do fresh embryo transfer. Assessments will be at Day 1, Day 3 and Day 5/6 according to Gardner's criteria 1999. Embryological and clinical data were recorded and then analyzed using SPSS (version 23) statistical software.

Official Title
-----------------
Achieving Better Clinical Outcomes With Blastocyt Transfer in Poor Responders: a Prospective Study

Conditions
-----------------
Poor Response to Ovulation Induction, Infertility, Female

Intervention / Treatment
-----------------
* Other: Cleavage stage transfer
* Other: Blast stage transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: poor responders females with AMH≤ 1.2ng and have ≤ 5 mature oocytes couples whose planning to do fresh transfer male partners have normal semen parameters according to WHO 2010. Exclusion Criteria: sperm or oocyte donation gestational carriers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cleavage stage transfer<br>Poor responders who transfer their embryos in cleavage stage on day 3 | Other: Cleavage stage transfer<br>* transferring embryos through ICSI procedures for poor responders on cleavage stage of embryonic development.<br>|
| Blast stage transfer<br>Poor responders who transfer their embryos on blast stage on day 5/6 | Other: Blast stage transfer<br>* transferring embryos through ICSI procedures for poor responders on blast stage of embryonic development.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | percentage of cycles started with the intent of egg retrieval that led to a live birth. | delivery of healthy neonate after 37 weeks of pregnancy | 
| Implantation rate | Percentage of the implanted embryos number for each group / number of transferred embryos. | 6 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Percentage of pregnant cases with fetal heart / transferred cases for each group | after 6 weeks of embryonic transfer | 
| Cancellation rate | percentage of blast transfer cases who did not achieve blast stage (cancelled cases) / total number of blast stage cases | 5:6 days of ICSI | 
| Fertilization rate | Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes | 16:19 hours after intracytoplasmic injection(ICSI) | 
| Cleavage rate | Percentage of cleaved embryos / Number of fertilized oocytes | 72 hours after ICSI | 
| High quality day 3 embryos | High quality D3 embryos according to Gardner's criteria / total cleaved embryos | 72 hours after ICSI | 
| Blast rate | Percentage of total blastocysts / Total cleaved embryos | 5:6 days of ICSI | 
| High quality blast rate | Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos. | 5:6 days of ICSI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancellation rate, Implantation rate, Live birth rate, Embryo transfer, Poor responders