The Effectiveness of Endometrial Injury in IVF

Not Applicable

• Conditions: Infertility
• Interventions: Procedure: endometrial scratch

• Registration Number: NCT02409745
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-06
• Study Start: 2015-02
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Last Update Submitted: 2015-04-18
• Last Update Posted: 2015-04-21
• Primary Completion: 2015-12
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Advanced age group-Luteal phase	endometrial scratch	Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer.
Young age group-Early follicular phase	endometrial scratch	Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer.
Advanced age group-Early follicular phase	endometrial scratch	Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer.
Young age group-Luteal phase	endometrial scratch	Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	35 days after embryo transfer	See heart beat with ultrasonic exam.

Secondary Outcome Measures

Name	Time	Method
Ectopic pregnancy rate	35 days after embryo transfer	No sac can be seen inside uterine 35 days after embryo transfer, but with high hCG level

Trial Locations

Locations (1)

Reproductive Medical Center, 1st Affiliated hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China