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

Endometriosis Clinical Trial

— APPOSE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04002141
• Other study ID #: 18-26544
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 17, 2019
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: July 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Ovarian Hyperstimulation

Intervention

Drug:
• Placebo oral tablet
1 tablet oral daily
• Letrozole
5mg oral daily

Locations

Country	Name	City	State
United States	UCSF Center for Reproductive Health	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Delta in Endometriosis Pain Score Pre and Post Stimulation With and Without Use Of Letrozole	To evaluate how letrozole impacts pain scores throughout controlled ovarian hyperstimulation in patients with endometriosis. Pain scores will be evaluated using a 0-10 visual acuity scale, where 0 is no pain and 10 is the worst imaginable pain. The average delta between pre-stimulation pain score and day of trigger shot pain score will be compared between patients with endometriosis receiving placebo and with endometriosis receiving letrozole.	Baseline ultrasound (day 2 of menstrual cycle) and day 12 (average day of trigger shot).
Secondary	Average Delta in Endometriosis Pain Score Pre and Post Stimulation Compared to No Endometriosis	To evaluate the impact of endometriosis on pain scores throughout controlled ovarian hyperstimulation. Pain scores will be evaluated using a 0-10 visual acuity scale, where 0 is no pain and 10 is the worst imaginable pain. The average delta between pre-stimulation pain score and day of trigger shot will be compared between patients with endometriosis receiving placebo and patients without endometriosis.	Baseline ultrasound (day 2 of menstrual cycle) and day 12 (average day of trigger shot).
Secondary	Trend in Endometriosis Pain Score Pre and Post Stimulation With Use Of Letrozole	To evaluate the impact of letrozole on endometriosis pain scores throughout controlled ovarian hyperstimulation. Pain scores will be evaluated using a 0-10 visual acuity scale, where 0 is no pain and 10 is the worst imaginable pain. The trend in pain scores from pre-stimulation through 12 weeks post retrieval will be compared between patients with endometriosis receiving placebo, patients with endometriosis receiving letrozole and patients without endometriosis.	Pre-stimulation through 12 weeks post retrieval
Secondary	Does Letrozole Impact Embryo and Egg Quantity in Endometriosis	To describe the impact of letrozole on egg/embryo quality in patients with endometriosis receiving letrozole and those with endometriosis not receiving letrozole during controlled ovarian stimulation. The number of eggs retrieved per AFC and the number of eggs retrieved per total number of mature follicles will be compared between the two groups.	Baseline ultrasound (day 2 of menstrual cycle) and day 14 (average day of egg retrieval).
Secondary	Follicular Fluid	To compare follicular fluid average estradiol levels between placebo, letrozole and control groups.	Baseline ultrasound (day 2 of menstrual cycle) and day 14 (average day of egg retrieval).
Secondary	Pregnancy Outcomes	To compare pregnancy rates in the placebo, letrozole and control groups. Pregnancy will be defined as positive serum hCG after transfer of embryo. The rate will determined by positive hCG per transfer.	Up to 2 years.
Secondary	Egg Maturity	To describe the impact of letrozole on egg maturity. Measured by number of MII eggs per total number eggs retrieved in patients with endometriosis receiving letrozole and those with endometriosis not receiving letrozole during controlled ovarian stimulation.	Baseline ultrasound to time of cryopreservation of eggs/embryos, which occurs within 7 days of retrieval..
Secondary	Embryo Grade	To describe the impact of letrozole on embryo quality. Measured by fraction of freezable quality embryos (6c or greater, grades 1-2 for symmetry and fragmentation) in patients with endometriosis receiving letrozole and those with endometriosis not receiving letrozole during controlled ovarian stimulation.	2 weeks