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Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate

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ClinicalTrials.gov Identifier: NCT03220503
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Yasser sherbiny, Ain Shams Maternity Hospital

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.


Condition or disease Intervention/treatment Phase
Infertility Procedure: endometrial injury Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate
Actual Study Start Date : March 8, 2017
Estimated Primary Completion Date : September 9, 2017
Estimated Study Completion Date : October 1, 2017

Arm Intervention/treatment
Experimental: Group (A)
consists of 25 patients will receive frozen embryo with endometrial scratching on day 7 of transfer cycle.
Procedure: endometrial injury
single induced injury will be done on the posterior endometrium on day 7 of the transfer cycle by using modified Cook catheter.

No Intervention: Group (B)
consists of 25 patients will receive frozen embryo without endometrial scratching as control group.



Primary Outcome Measures :
  1. Chemical pregnancy rate [ Time Frame: two weeks after frozen embryo transfer ]
    serum Beta -Human Chorionic Gonadotropin positive


Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: four weeks after frozen embryo transfer ]
    appearance of gestational sac on trans-vaginal ultrasound



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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220503


Contacts
Contact: Yasser Sherbiny, invistgator +201008961189 drysherbiny89@gmail.com

Locations
Egypt
ART unit - Ain Shams university Matrnity Hospital Recruiting
Cairo, Egypt
Contact: yasser sherbiny, invistgator    +201008961189    drysherbiny89@gmail.com   
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
Study Director: Adel Sh Salah El-Din, Ass. Prof. Ain Shams University
Study Director: Mohammed A Faris, Lecturer Ain Shams University
Study Director: Mohamed E Shawky, Lecturer Ain Shams University

Responsible Party: Yasser sherbiny, Principal Investigator, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03220503     History of Changes
Other Study ID Numbers: AinShamsMH Ysherbiny
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female