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ICSIICSINCT03470298

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

A study testing Endometrial scratching in people with ICSI, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 35 years, women only
Conditions the study is for
ICSI
What is being tested?
Endometrial scratching
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Jan 2017to 1 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fertility care unite,Mansoura university hospital.

    Al Mansurah

Other trials in Egypt

About this study

Official title: Retrieval Endometrial Scratching Versus Mid-luteal Endometrial Scratching for Women Undergoing ICSI for Unexplained Infertility

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.

Read the 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.

Conditions
ICSI
Being tested
Endometrial scratching
Keywords
Endometrial Scratching, Unexplained infertility, ICSI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endometrial scratchingProcedure or surgery

    Also called Endometrial injury

    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

Study groups in NCT03470298
Study groupRoleWhat they receive
Mid luteal Endometrial Scratching (MLES)Active comparatorMaking 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
Receives: Procedure: Endometrial scratching
Retrieval Endometrial Scratching (RES)Active comparatorMaking 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 .
Receives: Procedure: Endometrial scratching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live birth rate

    delivery of a fetus after passing medico legal viability

    Measured: about 9 months

Secondary outcomes (2)
  1. implantation rate

    positive pregnancy test

    Measured: 2 weeks after embryo transfer

  2. Clinical pregnancy rate

    Appearance of gestational sac by ultrasound with fetal pole and cardiac pulsation

    Measured: 4 weeks after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2018
  2. Study start1 Jan 2017
  3. Primary completion1 Jun 2018 (estimated)
  4. Study completion1 Jun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03470298
Sponsor's protocol ID
R/16.11.11
Other IDs
ABC123
Acronym
ICSI
Status last verified
Mar 2018
First submitted
7 Mar 2018
Last updated
19 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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 .

Publications

  • 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.

    PubMed 12798877

Questions about this trial

What is this clinical trial studying?

A study testing Endometrial scratching in people with ICSI, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth rate (time frame: about 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03470298, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.

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