Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Ain Shams Maternity Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Chemical pregnancy rate
Study Overview
Brief Summary
Research Question:
In women undergoing frozen embryo transfer, does routine endometrial injury before frozen embryo transfer increase clinical pregnancy rate?
Research Hypothesis:
(Null Hypothesis) In women undergoing frozen embryo transfer Routine endometrial injury before frozen embryo transfer does not increase clinical pregnancy rate.
(Alternative Hypothesis) In women undergoing frozen embryo transfer, endometrial injury before the transfer may increase pregnancy rate.
Detailed Description
Suitable women will be invited to participate in the study then a signed and informed consent will be obtained from them. When the patient's consent is obtained, they are to be included into the study.
Data Collection:
During first visit, all patients will undergo complete clinical examination and detailed medical history will be obtained. Each patient will have a Case Record Form (CRF) in which the following data will be recorded.
- Patient number (according to the randomization schedule).
- Age, BMI.
- Past medical and surgical history.
- Duration of infertility.
Procedure:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 40 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All infertile women have high quality frozen embryos.
Exclusion Criteria
- •History of endocrine disease such as: diabetes; Hyperthyroidism and Hyperprolactinemia.
- •History of hysteroscopic surgery due to intrauterine adhesions.
- •History of cardiovascular, renal or liver disease .
- •History of stroke or myocardial infarction.
- •Poor quality embryos.
- •Alcohol or Substance abuse.
Arms & Interventions
Group (A)
consists of 25 patients will receive frozen embryo with endometrial scratching on day 7 of transfer cycle.
Intervention: endometrial injury (Procedure)
Group (B)
consists of 25 patients will receive frozen embryo without endometrial scratching as control group.
Outcomes
Primary Outcomes
Chemical pregnancy rate
Time Frame: two weeks after frozen embryo transfer
serum Beta -Human Chorionic Gonadotropin positive
Secondary Outcomes
- Clinical pregnancy rate(four weeks after frozen embryo transfer)
Investigators
Yasser sherbiny
Principal Investigator
Ain Shams Maternity Hospital
