The Effectiveness of Endometrial Injury in IVF

Study Overview
=================
Brief Summary
-----------------
Many studies have demonstrated that endometrial scratch significantly increase pregnancy rate in patients undergoing in vitro fertilization and embryo transfer. However, only a limited number of studies have been conducted in frozen thawed transfer (FET) cycle. Nowadays, in FET cycles, endometrial scratch is mainly performed on two different time points: 1) luteal phase in the previous cycle; 2)early follicular phase in the current cycle. However, few studies have compared the effectiveness of those two different endometrial scratch methods performed in different timing. The aim of this study is to find the best timing of endometrial scratch in FET cycles.

Official Title
-----------------
The Effectiveness of Endometrial Injury in Different Phase of Menstrual Cycle:a Prospective Controlled Clinical Study

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: endometrial scratch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be aged younger than 40 years old; At least one period IVF-ET (fresh or thaw) has been done and not pregnant after at least one qualified blastocyst (more than 3BB) or two qualified embryos (more than II/6) have been transferred; There are qualified embryos thawed and the thaw-ET period will be taken. Exclusion Criteria: Malformation of uterus: such as uterus uni-corns, uterus bi-corns, untreated uterus septus, etc.; History of endometrial diseases: such as intrauterine adhesion, uterine cavity tuberculosis, severe dysplasia of endometrium, etc.; Multiple myomata or endometrioma which causes uterus oppression; Multiple and recurrent endometrial polyps; Pelvic tuberculosis, endometriosis.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Young age group-Luteal phase<br>Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer. | Procedure: endometrial scratch<br>* local injury to the endometrium by Pipelle<br>* Other names: endometrial injury;|
| Active Comparator: Young age group-Early follicular phase<br>Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer. | Procedure: endometrial scratch<br>* local injury to the endometrium by Pipelle<br>* Other names: endometrial injury;|
| Experimental: Advanced age group-Luteal phase<br>Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer. | Procedure: endometrial scratch<br>* local injury to the endometrium by Pipelle<br>* Other names: endometrial injury;|
| Active Comparator: Advanced age group-Early follicular phase<br>Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer. | Procedure: endometrial scratch<br>* local injury to the endometrium by Pipelle<br>* Other names: endometrial injury;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | See heart beat with ultrasonic exam. | 35 days after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ectopic pregnancy rate | No sac can be seen inside uterine 35 days after embryo transfer, but with high hCG level | 35 days after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In vitro fertilization, endometrial scratch, IVF, randomized controlled study, Prospective controlled trial, Different time to perform endometrial scratch, embryo transfer