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Endometrial Injury and Implantation Rates Before First ICSI Cycle

Does Local Endometrial Injury Improve Implantation Rates in Women Undergoing Their First ICSI Cycle.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02660125
Enrollment
300
Registered
2016-01-21
Start date
2016-01-31
Completion date
2017-03-31
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invitro Fertilization

Keywords

ICSI, endometrial injury, implantation rate

Brief summary

Midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix, the step that will be beneficial to embryo transfer procedure. Controller ovarian hyperstimulation; will be done using the long luteal phase agonist protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3 FSH and antral follicular count and previous history of ovarian response). Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when there is \>=1 follicle \>=18 mm. and \>=3 follicles \>=16 mm. Ultasound guided oocyte retrieval will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3 after oocyt retrieval according to number and quality of embryos. Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.

Interventions

midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

1. subfertile women indicated for ICSI. 2. normal uterine cavity demonstrated by transvaginal ultrasound and hystrogram. 3. FSH\<10mIU/mL on day 3 of her cycle.

Exclusion criteria

1. presence of endometrial polyp or fibroid distorting the uterine cavity. 2. hydrosalpinx. 3. ICSI carried out for preimplantation genetic diagnosis. 4. FSH\>10mIU\\mL.

Design outcomes

Primary

MeasureTime frameDescription
implantation rate14 days after embryo transfernumber of sacs identifiable through ultrasonography divided by the number of embryos transferred
clinical pregnancy rate4 weeks after embryo transferthe detection of fetal cardiac activity within a gestational sac on ultrasonography examination

Secondary

MeasureTime frameDescription
multiple pregnancy rate4 weeks after embryo transfernumber of patients who had a multifetal pregnancy divided by the total number of clinical pregnancies
abortion rate12 weeks of gestational agenumber of patients who had a spontaneous abortion before 12 weeks of pregnancy divided by total number of clinical pregnancies

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026