Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202404620924173 Date of Approval: 10/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Endometrial compaction (decreased thickness) and its effect on pregnancy rate in frozen embryo transfer cycles: an observational cohort study
Official scientific title Endometrial compaction (decreased thickness) and its effect on pregnancy rate in frozen embryo transfer cycles: an observational cohort study
Brief summary describing the background and objectives of the trial During frozen embryo transfer (FET), the receptive endometrium is the most important component for conception to occur. The endometrium's optimal receptive thickness is estimated to be between days 22 and 24 of the typical menstrual cycle. Endometrial thickness can be accurately measured using ultrasound instead of endometrial biopsy. Aim of the work: In the current study, we evaluated the role of endometrial compaction on the day of FET on the ICSI success rate and pregnancy rates
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 01/06/2021
Actual Last follow-up date 31/03/2022
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants) 96
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group frozen embryo transfer cycles The study was observational only, with no intervention. five day Patients will take oral administration of 2 mg micronized E2 twice daily, which will increase after 5 days to 4 mg twice daily. An ultra-sound measurement of endometrial thickness will perform 10 days after starting E2 to measure endometrial thickness and pattern 96
Control Group frozen embryo transfer cycles observational only, with no intervention five days Patients will take oral administration of 2 mg micronized E2 twice daily, which will increase after 5 days to 4 mg twice daily. An ultra-sound measurement of endometrial thickness will perform 10 days after starting E2 to measure endometrial thickness and pattern 96 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Infertile patient due to (male factor, female factor or unexplained) had frozen embryos from previous ICSI trial  Women aged between 18 years to 40 years  Written consent  Hormonally prepared endometrium  Endometrial thickness ≥8mm, trilaminar pattern,  At least 3 good quality embryos  Women aged >40 or <18 years  Chronic illnesses (Hypertension, diabetes, and cardiac diseases)  Endometrial thickness <8 mm or >14 mm or echogenic endometrium  Endometrial compaction >5%.  Refuse to participate study (measure of endometrium)  Duration of estradiol exposure >17 days.  Bad quality embryos. Adult: 19 Year-44 Year 18 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/10/2021 Cairo university
Ethics Committee Address
Street address City Postal code Country
manial city cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ongoing pregnancy rate (pregnancy ≥12 weeks of gestation) in patient with endometrial compaction compared to patient without endometrial compaction in FET cycles after 12 weeks
Secondary Outcome Biochemical pregnancy rate pregnancy test positive one to two weeks
Secondary Outcome Clinical pregnancy rate presence of a fetal heartbeat at 6-7 weeks of pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr AlAiny Hospital Cairo University Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded cairo cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor self sponsored Cairo Cairo 11562 Egypt self sponsored
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Amal Shohayeb Ahmed Mohamed amalshohayeb@gmail.com 01010284445 Cairo
City Postal code Country Position/Affiliation
Cairo 11562 Egypt lecturer of obstetric and gynecology
Role Name Email Phone Street address
Principal Investigator Dalia Adel Ahmed Nour Dalia.Adel@KasrAlEiny.edu.eg +201024748480 Cairo
City Postal code Country Position/Affiliation
Cairo 11562 Egypt lecturer of obstetric and gynecology
Role Name Email Phone Street address
Scientific Enquiries Radwa M. Fahmy RadwaFahmy@gmail.com +201061416790 Cairo
City Postal code Country Position/Affiliation
Cairo 11562 Egypt lecturer of obstetric and gynecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes There is no intended sharing of de-identified individual trial participant data because we will run a secondary analysis Study Protocol There is no intended sharing of de-identified individual trial participant data because we will run a secondary analysis Frozen embryo transfer cycle – Thickness – Pregnancy rate
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 03/04/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 03/04/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information