Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols

Study Overview
=================
Brief Summary
-----------------
Published data on sequential transfer are limited and are not consistent. Also, further research into methods of risk combination and assessment, would allow us to help our patients make better-informed decisions about whether or not to proceed with invasive diagnostic tests as the PGS. So our study aims to describe the ongoing pregnancy rate for poor responders women undergoing four different embryo transfer protocols among four arms within the study. Moreover, to describe the miscarriage rate, and the baseline characteristics for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.

Detailed Description
-----------------
The study aims to describe the ongoing pregnancy rate for poor responders women undergoing four different embryo transfer protocols among four arms within the study. Moreover, to describe the miscarriage rate, and the baseline characteristics for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements. This study is prospective, comparative, open label and multi-center study. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. The study materials that will be used will include blood tests, and ultrasound. The study will involve four study arms: Arm 1: Poor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5 Arm 2: Poor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5 Arm 3: Poor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS Arm 4: Poor responders women undergoing conventional frozen embryo transfer on Day 5 Primary and secondary key measurements will be used in the study. The primary measures will include: Presence of intrauterine gestational sac at 12 weeks beyond embryo transfer Presence of fetal heart pulsation at 12 weeks beyond embryo transfer The secondary key measures will include: Occurance of abortion between week 7 and week 20 of gestation Recording the the baseline characteristics of the study participants

Official Title
-----------------
A Prospective, Four Arms, Open Label, Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols

Conditions
-----------------
Embryo Transfer in Poor Responders

Intervention / Treatment
-----------------
* Procedure: Embryo transfer method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age group of these women is 25-45 years Normal endometrial cavity confirmed by hysteroscopy Poor responders with AMH <1 Patients with at least grade 1 days 3 embryo and grade 1 day 5 frozen embryos Exclusion Criteria: Patients with any immunological disorders Patients with uncontrolled systemic diseases Patients with previous uterine surgeries except for Cesarean section

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- |
| Arm 1<br>Poor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5 | Procedure: Embryo transfer method<br>* Sequential embryo transfer on day 3 and day 5 in a frozen cycle Sequential embryo transfer on day 3 and day 5 in a fresh cycle Sequential embryo transfer on day 3 and day 5 after performing PGS Conventional Day 5 frozen embryo transfer<br>|
| Arm 2<br>Poor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5 | Procedure: Embryo transfer method<br>* Sequential embryo transfer on day 3 and day 5 in a frozen cycle Sequential embryo transfer on day 3 and day 5 in a fresh cycle Sequential embryo transfer on day 3 and day 5 after performing PGS Conventional Day 5 frozen embryo transfer<br>|
| Arm 3<br>Poor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS | Procedure: Embryo transfer method<br>* Sequential embryo transfer on day 3 and day 5 in a frozen cycle Sequential embryo transfer on day 3 and day 5 in a fresh cycle Sequential embryo transfer on day 3 and day 5 after performing PGS Conventional Day 5 frozen embryo transfer<br>|
| Arm 4<br>Poor responders women undergoing conventional frozen embryo transfer on Day 5 | Procedure: Embryo transfer method<br>* Sequential embryo transfer on day 3 and day 5 in a frozen cycle Sequential embryo transfer on day 3 and day 5 in a fresh cycle Sequential embryo transfer on day 3 and day 5 after performing PGS Conventional Day 5 frozen embryo transfer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate for poor responders women in the four arms | Recording the following for the four arms of the study: Presence of intrauterine gestational sac at 12 weeks beyond embryo transfer Presence of fetal heart pulsation at 12 weeks beyond embryo transfer | Till the end of 12 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miscarriage rate for poor responders women in the four arms | Recording the following for the four arms of the study: - Occurance of abortion between week 7 and week 20 of gestation | Till the end of 20 weeks of gestation | 
| The baseline characteristics of the study participants | Recording the following for the four arms of the study: -age , body mass index in kg/m^2 | Before study intervention of the four arms (at day 2 in the ovulation induction cycle) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Poor responders, PGS, Sequential, Embryo transfer