Summary

for females ages 18-42 (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion
Marcelle I Cedars

Description

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.

Details

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.

Keywords

Endometriosis Ovarian Hyperstimulation Letrozole Endometriosis Letrozole

Eligibility

You can join if…

Open to females ages 18-42

  • 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

You CAN'T join if...

  • 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

Location

  • UCSF Center for Reproductive Health not yet accepting patients
    San Francisco California 94158 United States

Lead Scientist

  • Marcelle I Cedars
    Professor, Ob/Gyn, Reproductive Sciences. Authored (or co-authored) 215 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04002141
Phase
Phase 2
Study Type
Interventional
Last Updated