Clinical trial NCT04002141: Assessment and Prevention of Pain During Ovarian Stimulation in Patients With Endometriosis
Official title: Assessment and Prevention of Pain During Ovarian Stimulation in Patients With Endometriosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Endometriosis
Ovarian Hyperstimulation
Keywords: Endometriosis
Letrozole
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized double blinded placebo-controlled trial to evaluate the impact of ovarian hyperstimulation on endometriosis-related symptoms and to evaluate the impact of letrozole use during ovarian hyperstimulation with respect to endometriosis-related symptoms, embryo/egg quality and quantity, and pregnancy rates.

Detailed description: Randomized double blinded placebo-controlled trial to evaluate: (1) the impact of letrozole use during ovarian hyperstimulation with respect to endometriosis-related symptoms, embryo/egg quality and quantity, and pregnancy rates, (2) the impact of ovarian hyperstimulation on endometriosis-related symptoms.

There will be a total of 60 participants, 20 participants with endometriosis randomized to the placebo group, 20 participants with endometriosis randomized to the letrozole group and 20 control patients with no history of endometriosis. Letrozole and placebo medication will be started on the first day of gonadotropin injections and continued until the day of trigger shot. Medication will be restarted the night of egg retrieval and continued for 2 weeks post retrieval. Endometriosis associated symptoms will be evaluated using a survey modeled after the clinical survey developed by the World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project. Surveys will be administered at baseline ultrasound appointment for controlled ovarian hyperstimulation cycle, the day of trigger shot, 3 weeks following egg retrieval, 6 weeks following egg retrieval and 12 weeks following egg retrieval.

Eligibility criteria: Inclusion Criteria:

* Age 18-42 years
* Planning to undergo controlled ovarian hyperstimulation
* Prior diagnosis of endometriosis by one of the following: (1) surgical diagnosis (2) endometrioma on pelvic ultrasound
* Planning to freeze all retrieved oocytes/embryos prior to transfer

Exclusion Criteria:

* Hypersensitivity to letrozole
* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results

Primary outcomes:
measure: Average Delta in Endometriosis Pain Score Pre and Post Stimulation With and Without Use Of Letrozole
timeFrame: Baseline ultrasound (day 2 of menstrual cycle) and day 12 (average day of trigger shot).
Secondary outcomes:
measure: Average Delta in Endometriosis Pain Score Pre and Post Stimulation Compared to No Endometriosis
timeFrame: Baseline ultrasound (day 2 of menstrual cycle) and day 12 (average day of trigger shot).
measure: Trend in Endometriosis Pain Score Pre and Post Stimulation With Use Of Letrozole
timeFrame: Pre-stimulation through 12 weeks post retrieval
measure: Does Letrozole Impact Embryo and Egg Quantity in Endometriosis
timeFrame: Baseline ultrasound (day 2 of menstrual cycle) and day 14 (average day of egg retrieval).
measure: Follicular Fluid
timeFrame: Baseline ultrasound (day 2 of menstrual cycle) and day 14 (average day of egg retrieval).
measure: Pregnancy Outcomes
timeFrame: Up to 2 years.
measure: Egg Maturity
timeFrame: Baseline ultrasound to time of cryopreservation of eggs/embryos, which occurs within 7 days of retrieval..
measure: Embryo Grade
timeFrame: 2 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Center for Reproductive Health
state: California
Study officials:
affiliation: University of California, San Francisco
name: Marcelle I Cedars
role: PRINCIPAL_INVESTIGATOR
References: