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

NCT05152667 | Unknown

• 1 other identifier: Elbanna_001
• Study Type: observational
• Target: 354
• Locations: 1 country
• Sites: 1

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

Conditions

Adenomyosis; IVF

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Occurance of abortion or ectopic

  up to 13 weeks gestation

• Recording the baseline characteristics of the study participants

  Before study intervention

• Recording the baseline characteristics of the study participants

  Before study intervention

Study Arms (2)

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

levonorgestrel-releasing intrauterine device (LNG-IUS) DEVICE

Intervention is administered proceeding the ICSI

Also known as: oral progestin "Dienogest"

Arm 1

Eligibility Criteria

• Age: Up to 42 Years
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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"

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wael Elbanna Clinic: lead
• National Research Centre, Egypt: collaborator

Study Sites (1)

Wael Elbanna Clinic

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing director for Wael Elbanna Clinic

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: December 10, 2021
• Study Start: November 27, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 10, 2021

Record last verified: 2021-08

Locations

EG (1)