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

NCT ID: NCT05152667

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-27

Study Completion Date

2022-07-31

Brief Summary

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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

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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

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Adenomyosis IVF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Arm 1

Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI

levonorgestrel-releasing intrauterine device (LNG-IUS)

Intervention Type DEVICE

Intervention is administered proceeding the ICSI

Arm 2

Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI

No interventions assigned to this group

Interventions

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levonorgestrel-releasing intrauterine device (LNG-IUS)

Intervention is administered proceeding the ICSI

Intervention Type DEVICE

Other Intervention Names

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oral progestin "Dienogest"

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Patients ≤42 years old at the time of starting ICSI cycle
3. Cryopreserved embryo transfer cycles
4. The presence of at least one good cryopreserved day 3 embryo.

Exclusion Criteria

1. Transfer of a poor-quality embryo (grades 3 or 4)
2. History of myomectomy
3. Pelvic ultrasound that showed the presence of uterine fibroids, a hydrosalpinx or endometrial polyps (all known causes of implantation failure).
Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role collaborator

Wael Elbanna Clinic

OTHER

Sponsor Role lead

Responsible Party

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Wael Elbanna

Managing director for Wael Elbanna Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wael Elbanna Clinic

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Wael Saad Saad El Banna El Banna, MD

Role: CONTACT

Phone: +2 01227760402

Email: [email protected]

Eslam Fathy Fathy, M.Sc.

Role: CONTACT

Phone: 01092586140

Email: [email protected]

Facility Contacts

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wael Elbanna, consultant

Role: primary

manal elhinnawi, specialist

Role: backup

Other Identifiers

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Elbanna_001

Identifier Type: -

Identifier Source: org_study_id