Suspended

Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

endometrial injury

Procedure
Who is being recruted

Urogenital Diseases

+ Genital Diseases

+ Infertility

Until 40 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: March 2017
See protocol details

Summary

Principal SponsorAin Shams Maternity Hospital
Study ContactYasser Sherbiny, invistgator
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 8, 2017

Actual date on which the first participant was enrolled.

Suitable women will be invited to participate in the study then a signed and informed consent will be obtained from them. When the patient's consent is obtained, they are to be included into the study. Data Collection: During first visit, all patients will undergo complete clinical examination and detailed medical history will be obtained. Each patient will have a Case Record Form (CRF) in which the following data will be recorded. * Patient number (according to the randomization schedule). * Age, BMI. * Past medical and surgical history. * Duration of infertility. Procedure: Endometrial injury: A single induced injury will be done on the posterior endometrium on day 7 of the transfer cycle by using modified Cook catheter Protocol for vitrification Embryos will first loaded with equilibrium solution containing7.5% ethylene glycol (EG) and 7.5% dimethyl sulphoxide (DSMO) (Sigma-Aldrich) for 5-10 minute at room temperature and then with vitrification solution containing 15% EG, 15% DSMO and 0.5 mol/L sucrose for 50-60 seconds at room temperature. After observed cellular shrinkage, embryos will quickly stored in liquid nitrogen (LN) for at least 2 months. At warming, embryos will removed from LN and embryos will exposed to thawing solution containing sucrose at 37°C temperature for 50-60 seconds and then embryos will sequentially incubated in diluents solutions before being transferred . Evaluation and transfer of thawed embryos After thawing, each embryo will evaluated twice, once immediately for the number of surviving blastomeres and again after 18 hours post-thaw in vitro culture for assessing of mitosis and number of blastomeres. Embryos will considered survived if >50% of each blastomere are intact and selected for intrauterine transfer (Depending on patients' embryos, 2 or 3 embryos will transferred). Embryos will classified as fully intact or excellent morphology (100% cells survived with <10% fragmentation) or good morphology (100% cells survived with 10%-20% fragmentation), partially damaged or poor morphology (≥50% cells survived with or without any fragmentation) and Degenerated embryos (<50% cells survived) .Only fully intact and partially damaged embryos will transferred. Degenerated or arrested embryos will not transferred. Protocol of endometrial preparation before Frozen Embryo Transfer (FET) : There are different protocols for FET cycles. That is true for both "natural cycle" FETs and for "hormone replacement cycle" frozen-thawed embryo transfers. We will use hormone replacement cycles because they have better success rates. However, some clinics offer a natural cycle FET approach. Success rates are higher with hormone replacement, or "controlled" FET cycles. Medicines and Drugs in a Frozen Embryo Transfer FET Cycle 1. Gonadotropin-Releasing Hormone agonist (such as Lupron) will be given, either midluteal (day 21) or overlapping with a birth control pill. 2. Down-regulation will be confirmed by ultrasound and blood tests. 3. Estradiol valerate 2 mg twice daily (orally) will start after the period. This dose may need to be increased after monitoring of the uterine lining thickness. 4. When the endometrium has a "good" thickness( > 8 mm), progesterone will be started (intramuscular shots, or a vaginal product). 5. Embryo transfer will be planned for 3-6 days later - depending on the stage of development of the embryos to be transferred. 6. Estrogen and progesterone will be continued in the luteal phase. 7. Pregnancy testing will be done 9-14 days after transfer - depending on the stage of development of the embryos replaced and the preferences of the fertility clinic. 8. If pregnant, estrogen and progesterone will be continued until about 10-15 weeks of pregnancy and then weaned off.

Official TitleEffect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate
NCT03220503
Principal SponsorAin Shams Maternity Hospital
Study ContactYasser Sherbiny, invistgator
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Until 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesInfertility

Criteria

1 inclusion criteria required to participate
All infertile women have high quality frozen embryos.

6 exclusion criteria prevent from participating
History of endocrine disease such as: diabetes; Hyperthyroidism and Hyperprolactinemia.

History of hysteroscopic surgery due to intrauterine adhesions.

History of cardiovascular, renal or liver disease .

History of stroke or myocardial infarction.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
consists of 25 patients will receive frozen embryo with endometrial scratching on day 7 of transfer cycle.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

ART unit - Ain Shams university Matrnity Hospital

Cairo, EgyptOpen ART unit - Ain Shams university Matrnity Hospital in Google Maps
SuspendedOne Study Center