Ambispective Study to Assess the Effect of Pretreatment W... | NCT05152667

Studies
Ambispective Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin

NCT05152667

Sponsor

Wael Elbanna Clinic

Status

Unknown status

Last Update Posted

Dec 10, 2021Actual

Enrollment

354Estimated

Phase

Not provided

Conditions

Adenomyosis
IVF

Interventions

levonorgestrel-releasing intrauterine device (LNG-IUS)

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2021Actual

Primary Completion Date

Jul 2022Estimated

Completion Date

Jul 2022Estimated

First Submitted Date

Aug 13, 2021

First Submission Date that Met QC Criteria

Nov 27, 2021

First Posted Date

Dec 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2021

Last Update Posted Date

Dec 10, 2021Actual

Name	Class
National Research Centre, Egypt	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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). The study will involve two study arms

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

354Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1		Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI	Device: levonorgestrel-releasing intrauterine device (LNG-IUS)
Arm 2		Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
levonorgestrel-releasing intrauterine device (LNG-IUS)	Device	Intervention is administered proceeding the ICSI	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	up to 13 weeks gestation

Secondary Outcomes

Measure	Description	Time Frame
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	up to 13 weeks gestation
Recording the baseline characteristics of the study participants

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

42 Years

Standard Ages

ChildAdult

Study Population

The study population will include women with adenomyosis, proceeding with the ICSI and pretreated with either:

levonorgestrel-releasing intrauterine device (LNG-IUS)
Oral progestin "Dienogest"

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wael Saad Saad El Banna El Banna, MD	Contact	+2 01227760402		dr.wael.ss.elbanna@gmail.com
Eslam Fathy Fathy, M.Sc.	Contact	01092586140		eslam.f486@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wael Elbanna Clinic	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D062788	Adenomyosis

Ancestor Terms

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided