NCT04039204

Brief Summary

Studies suggest that undiagnosed endometriosis results in poor reproductive outcomes in the setting of In Vitro Fertilization and Embryo Transfer (IVF-ET). Biomarkers that predict endometriosis including B-cell lymphoma (BCL6) and Sirtuin 1 (SIRT1) are associated with reduced pregnancy rates following IVF-ET. Treatment with gonadotropin releasing hormone (GnRHr) receptor agonists (leuprolide acetate depot) has been shown to improve pregnancy rates following embryo transfer (ET). In this randomized controlled trial, a new generation GnRHr antagonist, elagolix, will be compared to oral contraceptives (OCPs) for suppression of suspected endometriosis prior to ET. Both groups will receive two months of treatment prior to frozen embryo transfer of a single euploid embryo. Outcomes will include pregnancy rate, miscarriage rate and ongoing and live birth rate following treatment. Patients experiencing unanticipated problems or who experience adverse events such that they do not tolerate the treatment they are assigned, will be allowed to discontinue treatment and be provided the opportunity to use the other treatment if they so choose. The outcomes of such cycles would be collected separately and included as observational data only and not included in the randomized data analysis. Alternatively, they can simply drop out of the study and resume medical therapy as appropriate or pursue frozen embryo transfer as previously planned.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
2.5 years until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 26, 2024

Completed
Last Updated

July 26, 2024

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

July 25, 2019

Results QC Date

June 14, 2024

Last Update Submit

July 25, 2024

Conditions

EndometriosisUnexplained Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of Live Births

    Month 9

Secondary Outcomes (2)

  • Number of Miscarriages

    week 15

  • Number of Viable Pregnancies

    12 to 15 weeks

Other Outcomes (1)

  • Inflammation Measurements

    week 15

Study Arms (2)

Elagolix

EXPERIMENTAL

Elagolix will be dosed at the higher dose used in pelvic pain trials, 200 mg twice a day for 2 months.

Drug: Elagolix

Oral contraceptives (Ortho Cyclen)

ACTIVE COMPARATOR

Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills.

Drug: Ortho Cyclen

Interventions

ElagolixDRUG

This orally active, reversible GnRH antagonist will be used to suppress endometriosis by lowering estrogen levels for 2 months prior to FET

Also known as: Orilissa
Elagolix
Ortho CyclenDRUG

Oral contraceptive prescribed by physician.

Oral contraceptives (Ortho Cyclen)

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women with infertility seeking embryo transfer are eligible to participate
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Anti-Mullerian Hormone (AMH) \> 0.5 and \< 10
  • At least 1 euploid embryo for transfer
  • Prior endometrial biopsy showing elevated BCL6 and SIRT1 expression
  • Endometrial thickness \> 5.9 and \< 14 mm

You may not qualify if:

  • Uterine fibroids \> 4 cm (intramural)
  • Polycystic ovary syndrome (Rotterdam criteria)
  • Ovarian failure and donor eggs or oocytes
  • Positive lupus anticoagulant or positive anti-cardiolipin antibody testing
  • Diabetes mellitus (Type I or II)
  • Untreated hypothyroidism
  • Untreated hyperprolactinemia
  • BMI \<17 or \> 35
  • Uncorrected uterine anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Univesity Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (5)

  • Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19.

    PMID: 28525302BACKGROUND

  • Surrey E, Taylor HS, Giudice L, Lessey BA, Abrao MS, Archer DF, Diamond MP, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Singh SS, Rechberger T, Agarwal SK, Duan WR, Schwefel B, Thomas JW, Peloso PM, Ng J, Soliman AM, Chwalisz K. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Obstet Gynecol. 2018 Jul;132(1):147-160. doi: 10.1097/AOG.0000000000002675.

    PMID: 29889764BACKGROUND

  • Likes CE, Cooper LJ, Efird J, Forstein DA, Miller PB, Savaris R, Lessey BA. Medical or surgical treatment before embryo transfer improves outcomes in women with abnormal endometrial BCL6 expression. J Assist Reprod Genet. 2019 Mar;36(3):483-490. doi: 10.1007/s10815-018-1388-x. Epub 2019 Jan 4.

    PMID: 30610661BACKGROUND

  • Almquist LD, Likes CE, Stone B, Brown KR, Savaris R, Forstein DA, Miller PB, Lessey BA. Endometrial BCL6 testing for the prediction of in vitro fertilization outcomes: a cohort study. Fertil Steril. 2017 Dec;108(6):1063-1069. doi: 10.1016/j.fertnstert.2017.09.017. Epub 2017 Nov 7.

    PMID: 29126613BACKGROUND

  • Littman E, Giudice L, Lathi R, Berker B, Milki A, Nezhat C. Role of laparoscopic treatment of endometriosis in patients with failed in vitro fertilization cycles. Fertil Steril. 2005 Dec;84(6):1574-8. doi: 10.1016/j.fertnstert.2005.02.059.

    PMID: 16359945BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

elagolixMoxifloxacin

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Bruce Lessey, Ph.D., M.D.
Organization
Wake Forest University School of Medicine
blessey@wakehealth.edu
336-713-0380

Study Officials

  • Bruce A Lessey, MD, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2019

First Posted

July 31, 2019

Study Start

January 15, 2022

Primary Completion

August 9, 2023

Study Completion

August 9, 2023

Last Updated

July 26, 2024

Results First Posted

July 26, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)