AdenomyosisNCT05152667
Ambispective Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin
An observational study of Adenomyosis and IVF, run by Wael Elbanna Clinic at 1 site in Egypt.
Trial summary
The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages Up to 42 years, women only
- Conditions the study is for
- Adenomyosis, IVF
- What is being tested?
- levonorgestrel-releasing intrauterine device (LNG-IUS)
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 354 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Nov 2021to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 42 years
- Women only
- Child, Adult
Study population: The study population will include women with adenomyosis, proceeding with the ICSI and pretreated with either: 1. levonorgestrel-releasing intrauterine device (LNG-IUS) 2. Oral progestin "Dienogest"
Who may be able to join
- Patients diagnosed using both the transvaginal ultrasound study (TVS) and MRI criteria
- Main criteria for sonographic and MRI diagnosis of adenomyosis are:
- The appearance of asymmetrical thickening of the myometrium Irregular cystic areas within the myometrium Linear striations radiating out from the myometrium
- Patients ≤42 years old at the time of starting ICSI cycle
- Cryopreserved embryo transfer cycles
- The presence of at least one good cryopreserved day 3 embryo.
Who cannot join
- Transfer of a poor-quality embryo (grades 3 or 4)
- History of myomectomy
- Pelvic ultrasound that showed the presence of uterine fibroids, a hydrosalpinx or endometrial polyps (all known causes of implantation failure).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Wael Elbanna Clinic
Cairo
wael Elbanna, consultant, 01227760402, waelelbanna@drwaelelbanna.com
manal elhinnawi, specialist, 01007970546
About this study
Official title: Ambispective Comparative Cohort Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin on ICSI and Vitrified-Warmed Embryo Transfer Outcomes in Women With Adenomyosis
The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms
Read the detailed description
The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms:
Arm 1: Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI Arm 2: Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI Primary and secondary key measurements will be used in the study.
The primary measures will include:
- Presence of intrauterine gestational sac at 12 weeks
- Presence of fetal heart pulsation at 12 weeks
The secondary key measures will include:
- Occurance of abortion in the 1st trimester
- Appearance of ectopic pregnancy diagnosis by:
Ultrasound Serum β-HCG level Symptoms of pain and bleeding
- Two serum β-HCG levels in 48hrs interval to emphasis biochemical pregnancy
- Recording the the baseline characteristics of the study participants
- Conditions
- Adenomyosis, IVF
- Being tested
- levonorgestrel-releasing intrauterine device (LNG-IUS)
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levonorgestrel-releasing intrauterine device (LNG-IUS)Device
Also called oral progestin "Dienogest"
Intervention is administered proceeding the ICSI
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI Receives: Device: levonorgestrel-releasing intrauterine device (LNG-IUS) | |
| Arm 2 | Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy
- Recording the following for the two arms of the study: Presence of intrauterine gestational sac at 12 weeks Presence of fetal heart pulsation at 12 weeks
Measured: up to 13 weeks gestation
Secondary outcomes (3)
Occurance of abortion or ectopic
Recording the following for the two arms of the study:
Occurance of abortion in the 1st trimester Appearance of ectopic pregnancy diagnosis Two serum β-HCG levels in 48hrs interval
Measured: up to 13 weeks gestation
Recording the baseline characteristics of the study participants
age
Measured: Before study intervention
Recording the baseline characteristics of the study participants
BMI in kg/m^2
Measured: Before study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start27 Nov 2021
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wael Elbanna Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Principal investigator, Wael Elbanna, Wael Elbanna Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152667
- Sponsor's protocol ID
- Elbanna_001
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambispective Comparative Cohort Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin on ICSI and Vitrified-Warmed Embryo Transfer Outcomes in Women With Adenomyosis
- ClinicalTrials.gov ID
- NCT05152667
- Acronym / sponsor ID
- Elbanna_001
- Conditions
- Adenomyosis, IVF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Wael Elbanna ClinicUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 27 Nov 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms
Detailed description
The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms:
Arm 1: Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI Arm 2: Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI Primary and secondary key measurements will be used in the study.
The primary measures will include:
- Presence of intrauterine gestational sac at 12 weeks
- Presence of fetal heart pulsation at 12 weeks
The secondary key measures will include:
- Occurance of abortion in the 1st trimester
- Appearance of ectopic pregnancy diagnosis by:
Ultrasound Serum β-HCG level Symptoms of pain and bleeding
- Two serum β-HCG levels in 48hrs interval to emphasis biochemical pregnancy
- Recording the the baseline characteristics of the study participants
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Device: levonorgestrel-releasing intrauterine device (LNG-IUS)Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI |
| Arm 2 | – | –Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI |
Who may qualify
- Ages
- Up to 42 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- The study population will include women with adenomyosis, proceeding with the ICSI and pretreated with either: 1. levonorgestrel-releasing intrauterine device (LNG-IUS) 2. Oral progestin "Dienogest"
Key inclusion criteria (6 listed)
- Patients diagnosed using both the transvaginal ultrasound study (TVS) and MRI criteria
- The appearance of asymmetrical thickening of the myometrium Irregular cystic areas within the myometrium Linear striations radiating out from the myometrium
- Patients ≤42 years old at the time of starting ICSI cycle
- Cryopreserved embryo transfer cycles
- The presence of at least one good cryopreserved day 3 embryo.
Key exclusion criteria (3 listed)
- Transfer of a poor-quality embryo (grades 3 or 4)
- History of myomectomy
- Pelvic ultrasound that showed the presence of uterine fibroids, a hydrosalpinx or endometrial polyps (all known causes of implantation failure).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levonorgestrel-releasing intrauterine device (LNG-IUS)Also: oral progestin "Dienogest"Intervention is administered proceeding the ICSI | Device | Arm 1 |
Primary outcome
ongoing pregnancy
Time frame: up to 13 weeks gestation
- Recording the following for the two arms of the study: Presence of intrauterine gestational sac at 12 weeks Presence of fetal heart pulsation at 12 weeks
3 secondary outcomes
Occurance of abortion or ectopic
Time frame: up to 13 weeks gestation
Recording the baseline characteristics of the study participants
Time frame: Before study intervention
Recording the baseline characteristics of the study participants
Time frame: Before study intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis and IVF, run by Wael Elbanna Clinic at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wael Saad Saad El Banna El Banna, MD (+2 01227760402, dr.wael.ss.elbanna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ongoing pregnancy (time frame: up to 13 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.