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OpenTrials
Completed

NCT Number: NCT02660125

Endometrial Injury and Implantation Rates Before First ICSI Cycle

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy medical school

Cairo, 12151, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. implantation rate

    Time frame: 14 days after embryo transfer

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

  2. clinical pregnancy rate

    Time frame: 4 weeks after embryo transfer

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

Secondary outcomes

  1. multiple pregnancy rate

    Time frame: 4 weeks after embryo transfer

    number of patients who had a multifetal pregnancy divided by the total number of clinical pregnancies

  2. abortion rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 21, 2016
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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