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Clinical Trials/NCT03220503
NCT03220503UnknownPhase 4

Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate

Ain Shams Maternity Hospital1 site in 1 country50 target enrollmentStarted: March 8, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
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)

Experimental

consists of 25 patients will receive frozen embryo with endometrial scratching on day 7 of transfer cycle.

Intervention: endometrial injury (Procedure)

Group (B)

No Intervention

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yasser sherbiny

Principal Investigator

Ain Shams Maternity Hospital

Study Sites (1)

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