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Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
endometrial injury
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

undefined - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • ART unit - Ain Shams university Matrnity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group (A)

Group (B)

Arm Description

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

consists of 25 patients will receive frozen embryo without endometrial scratching as control group.

Outcomes

Primary Outcome Measures

Chemical pregnancy rate
serum Beta -Human Chorionic Gonadotropin positive

Secondary Outcome Measures

Clinical pregnancy rate
appearance of gestational sac on trans-vaginal ultrasound

Full Information

First Posted
June 15, 2017
Last Updated
July 16, 2017
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03220503
Brief Title
Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate
Official Title
Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
September 9, 2017 (Anticipated)
Study Completion Date
October 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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: Endometrial injury: A single induced injury will be done on the posterior endometrium on day 7 of the transfer cycle by using modified Cook catheter Protocol for vitrification Embryos will first loaded with equilibrium solution containing7.5% ethylene glycol (EG) and 7.5% dimethyl sulphoxide (DSMO) (Sigma-Aldrich) for 5-10 minute at room temperature and then with vitrification solution containing 15% EG, 15% DSMO and 0.5 mol/L sucrose for 50-60 seconds at room temperature. After observed cellular shrinkage, embryos will quickly stored in liquid nitrogen (LN) for at least 2 months. At warming, embryos will removed from LN and embryos will exposed to thawing solution containing sucrose at 37°C temperature for 50-60 seconds and then embryos will sequentially incubated in diluents solutions before being transferred . Evaluation and transfer of thawed embryos After thawing, each embryo will evaluated twice, once immediately for the number of surviving blastomeres and again after 18 hours post-thaw in vitro culture for assessing of mitosis and number of blastomeres. Embryos will considered survived if >50% of each blastomere are intact and selected for intrauterine transfer (Depending on patients' embryos, 2 or 3 embryos will transferred). Embryos will classified as fully intact or excellent morphology (100% cells survived with <10% fragmentation) or good morphology (100% cells survived with 10%-20% fragmentation), partially damaged or poor morphology (≥50% cells survived with or without any fragmentation) and Degenerated embryos (<50% cells survived) .Only fully intact and partially damaged embryos will transferred. Degenerated or arrested embryos will not transferred. Protocol of endometrial preparation before Frozen Embryo Transfer (FET) : There are different protocols for FET cycles. That is true for both "natural cycle" FETs and for "hormone replacement cycle" frozen-thawed embryo transfers. We will use hormone replacement cycles because they have better success rates. However, some clinics offer a natural cycle FET approach. Success rates are higher with hormone replacement, or "controlled" FET cycles. Medicines and Drugs in a Frozen Embryo Transfer FET Cycle Gonadotropin-Releasing Hormone agonist (such as Lupron) will be given, either midluteal (day 21) or overlapping with a birth control pill. Down-regulation will be confirmed by ultrasound and blood tests. Estradiol valerate 2 mg twice daily (orally) will start after the period. This dose may need to be increased after monitoring of the uterine lining thickness. When the endometrium has a "good" thickness( > 8 mm), progesterone will be started (intramuscular shots, or a vaginal product). Embryo transfer will be planned for 3-6 days later - depending on the stage of development of the embryos to be transferred. Estrogen and progesterone will be continued in the luteal phase. Pregnancy testing will be done 9-14 days after transfer - depending on the stage of development of the embryos replaced and the preferences of the fertility clinic. If pregnant, estrogen and progesterone will be continued until about 10-15 weeks of pregnancy and then weaned off.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group (A)
Arm Type
Experimental
Arm Description
consists of 25 patients will receive frozen embryo with endometrial scratching on day 7 of transfer cycle.
Arm Title
Group (B)
Arm Type
No Intervention
Arm Description
consists of 25 patients will receive frozen embryo without endometrial scratching as control group.
Intervention Type
Procedure
Intervention Name(s)
endometrial injury
Intervention Description
single induced injury will be done on the posterior endometrium on day 7 of the transfer cycle by using modified Cook catheter.
Primary Outcome Measure Information:
Title
Chemical pregnancy rate
Description
serum Beta -Human Chorionic Gonadotropin positive
Time Frame
two weeks after frozen embryo transfer
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
appearance of gestational sac on trans-vaginal ultrasound
Time Frame
four weeks after frozen embryo transfer

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasser Sherbiny, invistgator
Phone
+201008961189
Email
drysherbiny89@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adel Sh Salah El-Din, Ass. Prof.
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammed A Faris, Lecturer
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed E Shawky, Lecturer
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
ART unit - Ain Shams university Matrnity Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yasser sherbiny, invistgator
Phone
+201008961189
Email
drysherbiny89@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate

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