Endometrial Injury and Implantation Rates Before First ICSI Cycle

Not Applicable

Completed

• Conditions: Invitro Fertilization
• Interventions: Procedure: Endometrial scratch injury

• Registration Number: NCT02660125
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-17
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-21
• Primary Completion: 2017-01
• Study Completion: 2017-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endometrial scratch injury	Endometrial scratch injury	endometrial scratch done before ICSI cycle

Primary Outcome Measures

Name	Time	Method
implantation rate	14 days after embryo transfer	number of sacs identifiable through ultrasonography divided by the number of embryos transferred
clinical pregnancy rate	4 weeks after embryo transfer	the detection of fetal cardiac activity within a gestational sac on ultrasonography examination

Secondary Outcome Measures

Name	Time	Method
multiple pregnancy rate	4 weeks after embryo transfer	number of patients who had a multifetal pregnancy divided by the total number of clinical pregnancies
abortion rate	12 weeks of gestational age	number of patients who had a spontaneous abortion before 12 weeks of pregnancy divided by total number of clinical pregnancies

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt