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Retrieval Versus Mid-luteal Endometrial Scratching (ES) for Intra Cytoplasmic Sperm Injection (ICSI) (ICSI)

Primary Purpose

ICSI

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endometrial scratching
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ICSI focused on measuring Endometrial Scratching, Unexplained infertility, ICSI

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with at least one previous failed ICSI cycles, Good responders in the previous ICSI cycle and Less than or equal to 35 years

Exclusion Criteria:. We excluded patients with; Presence of intramural fibroid distorting the endometrial cavity/sub mucous myoma/a Sherman's syndrome, Presence of son graphically detected hydrosalpinx, Patient age more than 35 years

Sites / Locations

  • Fertility care unite,Mansoura university hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mid luteal Endometrial Scratching (MLES)

Retrieval Endometrial Scratching (RES)

Arm Description

Making injury to endometrium by using Manual Vacuum Aspiration cannula size 5 . At this arm scratching done at mid luteal phase (day21) of the cycle before induction for ICSI

Making injury to endometrium by using Manual Vacuum Aspiration cannula size 5 .Here scratching done at same day of ovum pick up of ICSI cycle the difference only between arm of MLES and RES only in the timing of scratching .

Outcomes

Primary Outcome Measures

Live birth rate
delivery of a fetus after passing medico legal viability

Secondary Outcome Measures

implantation rate
positive pregnancy test
Clinical pregnancy rate
Appearance of gestational sac by ultrasound with fetal pole and cardiac pulsation

Full Information

First Posted
March 7, 2018
Last Updated
March 16, 2018
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03470298
Brief Title
Retrieval Versus Mid-luteal Endometrial Scratching (ES) for Intra Cytoplasmic Sperm Injection (ICSI)
Acronym
ICSI
Official Title
Retrieval Endometrial Scratching Versus Mid-luteal Endometrial Scratching for Women Undergoing ICSI for Unexplained Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
June 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ES is a procedure used to help embryos to implant more successfully after In-Vitro Fertilization (IVF) , ICSI in patients who had failed cycles in spite of transfer of good quality embryos. New researches and evidence suggests that scratching the uterine endometrium causes a repair reaction in patients may increase embryo implantation rate . In spit of the optimum timing of scratching not finally determined, the usual timing to perform ES is approximately one week before starting IVF, ICSI treatment . our study aims to compare other time of scratching which is the scratching at retrieval time.
Detailed Description
Endometrial scratching (ES) is a procedure used to help embryos to implant more successfully after In-Vitro Fertilization (IVF), ICSI in patients who had failed cycles in spite of transfer of good quality embryos. New researches and evidence suggests that scratching the uterine endometrium causes a repair reaction in patients may increase embryo implantation rate. The usual timing to perform ES is approximately one week before starting IVF, ICSI treatment. Aim: Comparing results of performing endometrial scratching one week before starting ICSI cycle treatment and at day of oocyte retrieval. Material &Methods : This is a prospective clinical trial, involving patients undergoing ICSI treatment at fertility care unite, Mansoura University Hospital and private fertility centers. The subjects were recruited from the period between January 2017 and June 2018. An informed consent obtained. Sample size was calculated using Graph Pad Inset soft were, version 3.01.Twenty four patient in each group were required to give the study a power of 80% and α of 0.05. Good responders were defined as the patients who had develop, at least four good-quality embryos grade 1 and 2 of Veeck's grading in the previous IVF cycle. Patients found eligible for the study were offered to undergo endometrial scratch-suction either in The usual timing to perform ES is approximately one week before starting IVF, ICSI treatment, the other at the time of oocyte retrieval, just after finishing oocyte pickup. All patients were evaluated with basal (day 3) Follicle Stimulating Hormone( FSH), and antral follicle count of the cycle prior to the embryo transfer cycle. Each woman recruited in the study underwent the same Controlled Ovarian Stimulation (COH) protocol that she had undergone in the previous ICSI cycles, which included only, long mid luteal phase Gonadotroph in Releasing Hormone (GnRH) agonist suppression . Records of previous stimulation protocols and embryology details were reviewed. The patients in study undergo endometrial scratch technique after being randomly assigned in to one of two groups. First group undergo oocyte pickup just after finishing oocyte pick up and the other group undergo oocyte pickup one week before starting COH. Manual Vacuum Aspiration (MVA) size 5 moved from below upwards with suction scratching anterior uterine wall then posterior then left lateral uterine wall then right lateral uterine wall and lastly fundus. All patients were prescribed vibramycine 100 mg twice daily for 3 days starting one day before procedure. In the long protocol, patients were down regulated with 0.1 mg GnRH agonist for the period of 10 - 14 days following which the dose was reduced to 0.5 mg and continued till human chorionic gonadotrophine (hCG) . After confirming adequate down-regulation, FSH, in the dose ranging from 150 to 250 IU, was commenced. FSH was continued till ovulation triggering .Women were scheduled for oocyte retrieval when at least three follicles reached a size of 18 mm. Oocyte retrieval was performed by the trans vaginal route under ultrasound guidance, 34-hr after HCG trigger with 5000 -1000 IU, with the patient under conscious sedation. The morphology of each aspirated oocyte was noted after denudation with hyaluronidase . ICSI was performed for all patients .The embryos were classified according to Veeck's grading as follows: Grade 1 - preembryos with blastomeres of equal size and no cytoplasmic fragmentation; Grade 2 - preembryos with blastomeres of equal size with cytoplasmic fragmentation equal to 15% of the total embryonic volume. Grade 3 - uneven blastomeres with no fragmentation; Grade 4 - uneven blastomeres with gross fragmentation (≥20% fragments) . Grade 1 or 2 embryos were considered to be good-quality embryos. Embryo transfer was performed with a Wallace® catheter (Smith Medical International Ltd., Hythe, Kent, UK) on day 3 a traumatically under ultrasound guidance by a senior consultant. we transfer up to three good-quality embryos. β-hCG was determined 2 weeks after the embryo transfer. Statistical analysis All statistical analyses using SPSS for windows version 17.0 (SPSS, Chicago, IL). Continuous data were expressed as mean ±SD and compared between the two groups using independent Student's t test. Categorical data were expressed in number and percent and compared using the χ2 test. The 95 % confidence intervals (CI) for the difference in means were calculated. Statistical significance was set at p<0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICSI
Keywords
Endometrial Scratching, Unexplained infertility, ICSI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients in study undergo endometrial scratch technique after being randomly assigned in to one of two groups . First group undergo ES just after finishing oocyte pick up and the other group undergo ES one week before starting COH. Manual Vacuum Aspiration (MVA) size 5 moved from below upwards with suction ,scratching anterior uterine wall then posterior then left lateral uterine wall then right lateral uterine wall and lastly funds.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mid luteal Endometrial Scratching (MLES)
Arm Type
Active Comparator
Arm Description
Making injury to endometrium by using Manual Vacuum Aspiration cannula size 5 . At this arm scratching done at mid luteal phase (day21) of the cycle before induction for ICSI
Arm Title
Retrieval Endometrial Scratching (RES)
Arm Type
Active Comparator
Arm Description
Making injury to endometrium by using Manual Vacuum Aspiration cannula size 5 .Here scratching done at same day of ovum pick up of ICSI cycle the difference only between arm of MLES and RES only in the timing of scratching .
Intervention Type
Procedure
Intervention Name(s)
Endometrial scratching
Other Intervention Name(s)
Endometrial injury
Intervention Description
The patients in study undergo endometrial scratch technique after being randomly assigned in to one of two groups . First group undergo oocyte pickup just after finishing oocyte pick up and the other group undergo oocyte pickup one week before starting COH.ManualVaccum Aspiration (MVA) size 5 moved from below upwards with suction ,scrachning anterior uterine wall then posterior then left lateral uterine wall then right lateral uterine wall and lastly fundus. All patients were prescribed vibramycine 100 mg twice daily for 3 days starting one day before procedure
Primary Outcome Measure Information:
Title
Live birth rate
Description
delivery of a fetus after passing medico legal viability
Time Frame
about 9 months
Secondary Outcome Measure Information:
Title
implantation rate
Description
positive pregnancy test
Time Frame
2 weeks after embryo transfer
Title
Clinical pregnancy rate
Description
Appearance of gestational sac by ultrasound with fetal pole and cardiac pulsation
Time Frame
4 weeks after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with at least one previous failed ICSI cycles, Good responders in the previous ICSI cycle and Less than or equal to 35 years Exclusion Criteria:. We excluded patients with; Presence of intramural fibroid distorting the endometrial cavity/sub mucous myoma/a Sherman's syndrome, Presence of son graphically detected hydrosalpinx, Patient age more than 35 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelhady A Zayed, Ass. prof.
Organizational Affiliation
Mansoura university hospital ,Mansoura,Dakahlia,Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility care unite,Mansoura university hospital.
City
Mansourah
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet decided if individual participant data will be available or not except after completion of study and counseling all persons sharing in the study .
Citations:
PubMed Identifier
12798877
Citation
Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
Results Reference
background
Links:
URL
http://doi.org/10.1093/humrep/dew053
Description
Mansoura university
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://doi.org/10.1093/humrep/dew053
Available IPD/Information Identifier
ABC123

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Retrieval Versus Mid-luteal Endometrial Scratching (ES) for Intra Cytoplasmic Sperm Injection (ICSI)

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