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

What Was Tested

The trial (early phase 1) is built around Leuprolide and Elagolix (non-peptide) for endometriosis.

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.

It had two arms (groups): Test group (experimental) and Control group (active comparator).

Subjects will receive the medication elagolix.

Subjects will receive leuprolide acetate.

The registry classes the interventions as diagnostic test and drug.

More on the Plan

Baseline visit prior to initiation of IVF cycle: Review nature of study, confirm surgical diagnosis of endometriosis, obtain informed consent, confirm absence of exclusion criteria 2.

Initial study entry visit performed within 4 weeks of initial medication administration after confirmation of presence of euploid embryo(s): Complete blood count, chemistry, renal and liver function panels.

Standard monitoring with serial ultrasound examination and assessment of serial estradiol, LH and progesterone levels will be performed per CCRM protocols.

Once appropriate endometrial development has been achieved after a minimum of 10 days of preparation, both intravaginal and intramuscular progesterone will be added to the estradiol with planned embryo transfer on the sixth day of progesterone administration 8.

Who Took Part

The registry lists 30 actual participants took part.

It was open to women only aged from 21 years up to 42 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Diagnosis of infertility who are candidate for IVF. Surgical diagnosis of endometriosis within 10 years of study entry. Willing to sign/give informed consent and adhere to parameters of study. Normal endometrial cavity as diagnosed by 3D ultrasound and office hysteroscopy examinations at baseline or after correction of underlying clinically relevant cavity abnormalities. 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.

The full record lists 12 inclusion and 18 exclusion criteria; among the exclusions: age \<21 or \> 42 years at time of initiation of ivf cycle; 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; planned use of donor oocytes or embryos.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

Nothing was hidden in this open-label Leuprolide study: the endometriosis participants and staff both knew the treatment.

It started in 2020-09-01 with completion listed for 2024-09-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Comparison of Implantation Rates (time frame: 2-3 weeks after initial positive pregnancy test (approx 14-15 weeks post initiation of treatment)).

It also tracked 3 secondary outcomes, for example Comparison of Biochemical pregnancy rates, Comparison of hormone levels between the two groups and Comparison of live birth rates and pregnancy loss rates.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Leuprolide and Elagolix (non-peptide) in 30 people with endometriosis.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page and the Elagolix (non-peptide) compound page, Endometriosis research.