Clinical trial: Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis (NCT04445025)

Eligibility 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
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 42 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction