Endometrial Injury and Implantation Rates Before First ICSI Cycle

NCT02660125 | Completed DMC

• 1 other identifier: 144
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Invitro Fertilization

Keywords

ICSI; endometrial injury; implantation rate

Outcome Measures

Primary Outcomes (2)

• implantation rate

  number of sacs identifiable through ultrasonography divided by the number of embryos transferred

  14 days after embryo transfer

• clinical pregnancy rate

  the detection of fetal cardiac activity within a gestational sac on ultrasonography examination

  4 weeks after embryo transfer

Secondary Outcomes (2)

• multiple pregnancy rate

  4 weeks after embryo transfer

• abortion rate

  12 weeks of gestational age

Study Arms (2)

endometrial scratch injury

ACTIVE COMPARATOR

endometrial scratch done before ICSI cycle

Procedure: Endometrial scratch injury

control

NO INTERVENTION

IcSI cycle without prior endometrial injury

Interventions

Endometrial scratch injury PROCEDURE

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

endometrial scratch injury

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

Related Publications (1)

• Maged AM, Rashwan H, AbdelAziz S, Ramadan W, Mostafa WAI, Metwally AA, Katta M. Randomized controlled trial of the effect of endometrial injury on implantation and clinical pregnancy rates during the first ICSI cycle. Int J Gynaecol Obstet. 2018 Feb;140(2):211-216. doi: 10.1002/ijgo.12355. Epub 2017 Nov 18.

  PMID: 29048754 DERIVED

Study Officials

• Ahmed Maged

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 17, 2016
• First Posted: January 21, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

EG (1)