Trial Outcomes & Findings for The Luveris In Vitro Fertilization Trial (NCT NCT00889512)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

2 years

Results posted on

2018-08-07

Participant milestones
Measure	Luveris Fixed Dose Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout. Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation	Luveris Increasing Dose Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle. Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG
Overall Study STARTED	5	9
Overall Study COMPLETED	5	9
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

The Luveris In Vitro Fertilization Trial

Baseline characteristics by cohort
Measure	Luveris Fixed Dose n=5 Participants Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout. Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation	Luveris Increasing Dose n=9 Participants Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle. Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

Timeframe: 2 years

Outcome measures
Measure	Luveris Fixed Dose n=5 Participants Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout. Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation	Luveris Increasing Dose n=9 Participants Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle. Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG
The Primary Outcome Will be Number of Large Follicles (16 mm or Greater in Diameter) and Midsize Follicles (Greater Than 12mm But Less Than 16mm) in Both Groups on the Day of Meeting Size Criteria for hCG. Large Follicles	3 number of follicles Interval 3.0 to 6.0	3 number of follicles Interval 2.0 to 5.0
The Primary Outcome Will be Number of Large Follicles (16 mm or Greater in Diameter) and Midsize Follicles (Greater Than 12mm But Less Than 16mm) in Both Groups on the Day of Meeting Size Criteria for hCG. Midsize Follicles	4 number of follicles Interval 2.0 to 10.0	4 number of follicles Interval 1.0 to 8.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University Reproductive Associates

Phone: 201-288-6330