Clinical trial

Assessment and Prevention of Pain During Ovarian Stimulation in Patients With Endometriosis

Name

18-26544

Description

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.

Trial arms

Trial start

2019-09-17

Estimated PCD

2023-10-01

Trial end

2024-07-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Placebo oral tablet

1 tablet oral daily

Arms:

Endometriosis Placebo

Letrozole

5mg oral daily

Arms:

Endometriosis Letrozole

Size

Primary endpoint

Average Delta in Endometriosis Pain Score Pre and Post Stimulation With and Without Use Of Letrozole

Baseline ultrasound (day 2 of menstrual cycle) and day 12 (average day of trigger shot).

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 65, 'type': 'ACTUAL'}}

Updated at

2023-11-18

1 organization

1 product

1 drug

2 indications

Organization

University of California, San Francisco

Product

Placebo

Indication

Endometriosis

Indication

Ovarian Hyperstimulation

Drug

Tucidinostat