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

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

Study Overview

• Status: Recruiting
• Conditions: Adenomyosis; IVF
• Intervention / Treatment: Device: levonorgestrel-releasing intrauterine device (LNG-IUS)

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 Type: Observational
• Enrollment (Anticipated): 354

Contacts and Locations

• Study Contact: Name: Eslam Fathy Fathy, M.Sc.; Phone Number: 01092586140; Email: eslam.f486@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Wael Elbanna Clinic
    • Contact: manal elhinnawi, specialist; Phone Number: 01007970546

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 42 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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"

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Intervention is administered proceeding the ICSI; Other Names: oral progestin "Dienogest"
Arm 2; Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	age	Before study intervention
Recording the baseline characteristics of the study participants	BMI in kg/m^2	Before study intervention

Collaborators and Investigators

• Sponsor: Wael Elbanna Clinic
• Collaborators: National Research Centre, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2021
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: November 27, 2021
• First Posted (ACTUAL): December 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2021
• Last Update Submitted That Met QC Criteria: November 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Adenomyosis; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Levonorgestrel; Progestins; Dienogest
• Other Study ID Numbers: Elbanna_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No