Endometrial Injury and Implantation Rates Before First ICSI Cycle

Invitro Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660125
• Other study ID #: 144
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Invitro Fertilization

Intervention

Procedure:
• Endometrial scratch injury
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

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implantation rate	number of sacs identifiable through ultrasonography divided by the number of embryos transferred	14 days after embryo transfer
Primary	clinical pregnancy rate	the detection of fetal cardiac activity within a gestational sac on ultrasonography examination	4 weeks after embryo transfer
Secondary	multiple pregnancy rate	number of patients who had a multifetal pregnancy divided by the total number of clinical pregnancies	4 weeks after embryo transfer
Secondary	abortion rate	number of patients who had a spontaneous abortion before 12 weeks of pregnancy divided by total number of clinical pregnancies	12 weeks of gestational age