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Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445025
Recruitment Status : Not yet recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Eric Surrey, M.D., Colorado Center for Reproductive Medicine

Brief Summary:

Patients who have been previously surgically diagnosed with endometriosis and have embryos predicted to be euploid after in vitro fertilization will be divided into 2 groups via randomization. The test group will receive Elagolix for 60 days prior to starting frozen embryo transfer preparation. The control group will be given leuprolide acetate every 28 days x 2 prior to starting the frozen embryo transfer preparation.

Comparative implantation rates between two groups of patients will be evaluated


Condition or disease Intervention/treatment Phase
Infertility Endometriosis Drug: Elagolix 200 MG Drug: Leuprolide Acetate 3.75 MG/ML Diagnostic Test: Lab work Early Phase 1

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Study Type : Interventional
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Test group will receive Elagolix 60 days prior to initiating frozen embryo transfer preparation.

Control group will receive depot leuprolide twice (once every 28 days) prior to initiation frozen embryo transfer preparation.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Elagolix in Comparison to Leuprolide Acetate on in Vitro Fertilization (IVF) Cycle Outcomes After a Transfer of Euploid Embryos to Patients With Surgically Diagnosed Endometriosis: A Pilot Trial
Estimated Study Start Date : August 3, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: Test group
Subjects will receive the medication elagolix
Drug: Elagolix 200 MG
Elagolix 200mg twice daily orally for 60 days prior to beginning frozen embryo transfer preparation

Diagnostic Test: Lab work
Serum follicle stimulating hormone (FSH), estradiol, luteinizing hormone (LH), progesterone, human chorionic gonadotropin (hCG), serum for microarray analysis, complete blood count, and chemistry panel with liver functions levels will be drawn via blood draw

Active Comparator: Control group
Subjects will receive leuprolide acetate
Drug: Leuprolide Acetate 3.75 MG/ML
Leuprolide Acetate intramuscularly every 28 days (twice) prior to beginning frozen embryo transfer preparation

Diagnostic Test: Lab work
Serum follicle stimulating hormone (FSH), estradiol, luteinizing hormone (LH), progesterone, human chorionic gonadotropin (hCG), serum for microarray analysis, complete blood count, and chemistry panel with liver functions levels will be drawn via blood draw




Primary Outcome Measures :
  1. Comparison of Implantation Rates [ Time Frame: 2-3 weeks after initial positive pregnancy test (approx 14-15 weeks post initiation of treatment) ]
    Implantation rates of both groups will be compared (defined as number of intrauterine gestational sacs with visible cardiac activity noted on ultrasound examination performed 2-3 weeks after initial positive pregnancy test)


Secondary Outcome Measures :
  1. Comparison of Biochemical pregnancy rates [ Time Frame: 2-3 weeks after initial positive pregnancy test (approx 14-15 weeks post initiation of treatment) ]
    Comparative biochemical pregnancy rates (positive pregnancy tests with no evidence of intrauterine gestational sac noted at ultrasound performed 2-3 weeks after initial positive pregnancy test) per embryo transfer

  2. Comparison of hormone levels between the two groups [ Time Frame: 4 weeks and 8 weeks after initiation of treatment ]
    FSH, LH, Estradiol, progesterone will compared after 4 weeks and 8 weeks of initiation of treatment

  3. Comparison of live birth rates and pregnancy loss rates [ Time Frame: 10-11 months after initiation of treatment ]
    At the end of the pregnancy. Live birth rates and pregnancy loss rates will be compared between the two groups



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Ages Eligible for Study:   21 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Diagnosis of infertility who are candidate for IVF
  2. Surgical diagnosis of endometriosis within 10 years of study entry
  3. Willing to sign/give informed consent and adhere to parameters of study
  4. Normal endometrial cavity as diagnosed by 3D ultrasound and office hysteroscopy examinations at baseline or after correction of underlying clinically relevant cavity abnormalities
  5. Day 2-4 serum FSH level ≤ 12 mIu/mL and/or random serum AMH level ≥ 0.9 ng/mL and/or antral follicular phase follicle count obtained by trans-vaginal ultrasound examination ≥ 5
  6. No contraindication to GnRH agonist or GnRH antagonist use
  7. No prolonged use of GnRH agonist or antagonist (> 30 consecutive days) or other treatment for endometriosis within 4 months of study entry
  8. Have at least one euploid embryo available for transfer
  9. Agrees to transfer best quality embryo as determined by CCRM physician and embryology team
  10. Regular menses ranging from 22-36 days
  11. Agrees to use barrier contraception throughout GnRH agonist or antagonist administration
  12. No evidence of untreated hydrosalpinx

Exclusion Criteria:

  1. Age <21 or > 42 years at time of initiation of IVF cycle
  2. Day 2-4 FSH level >12 mIu/mL or random serum AMH level <1.0 ng/mL and antral follicle count obtained by trans-vaginal ultrasound examination < 5
  3. Planned use of donor oocytes or embryos
  4. Planned use of gestational carrier
  5. Use of GnRH agonist, GnRH antagonist or other approved medical therapy for endometriosis (with the exception of combination contraceptives) for > 30 consecutive days prior to study entry
  6. Unwilling to abide by study parameters or sign informed consent
  7. No documentation of surgical diagnosis of endometriosis with study timeline (10 years of study entry)
  8. Absence of embryos predicted to be euploid available for transfer (embryos with no results may not be included in transfer)
  9. Prior adverse reaction to any GnRH agonist or antagonist
  10. Uncorrected or uncorrectable clinically relevant uterine cavity abnormalities or hydrosalpinx
  11. Acute or chronic renal, pulmonary, hepatic, or cardiac disease
  12. Prior diagnosis of pituitary adenoma or any other intracranial lesion
  13. Menstrual cycles outside the range of inclusion criteria
  14. Diagnosis of polycystic ovary syndrome (PCOS)
  15. Pregnancy prior to study initiation or initiation of endometrial preparation for embryo transfer.
  16. Undiagnosed vaginal bleeding
  17. Clinically relevant adenomyosis as diagnosed by baseline 3D ultrasound exam (and/or MRI if felt to be appropriate)
  18. Bipolar disorder, history of suicidal ideation, any other psychiatric disorder requiring lithium or anti-psychotic medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445025


Contacts
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Contact: Rachel Makloski, RN 303-788-8300 ext 1769 rmakloski@colocrm.com

Locations
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United States, Colorado
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, United States, 80124
Sponsors and Collaborators
Colorado Center for Reproductive Medicine
AbbVie
Investigators
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Principal Investigator: Eric Surrey, MD Colorado Center for Reproductive Medicine
Publications of Results:
Other Publications:

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Responsible Party: Eric Surrey, M.D., Medical Director, Colorado Center for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT04445025    
Other Study ID Numbers: elagolix
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infertility
Endometriosis
Genital Diseases, Male
Genital Diseases, Female
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents