Trial Outcomes & Findings for Comparative Study Between Minidose Long Protocol and Microdose Flare Protocol in Controlled Ovarian Hyperstimulation (NCT NCT02342197)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

12 months

Results posted on

2015-01-28

Participant milestones
Measure	Minidose Long Protocol Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle. Decapeptyl: half the dose of Gn agonist	Microdose Flare Protocol Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's Decapeptyl: half the dose of Gn agonist
Overall Study STARTED	30	30
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	3	2

Withdrawal data not reported

Comparative Study Between Minidose Long Protocol and Microdose Flare Protocol in Controlled Ovarian Hyperstimulation

Baseline characteristics by cohort
Measure	Minidose Long Protocol n=30 Participants Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle. Decapeptyl: half the dose of Gn agonist	Microdose Flare Protocol n=30 Participants Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's Decapeptyl: half the dose of Gn agonist	Total n=60 Participants Total of all reporting groups
Age, Continuous	37.4 years STANDARD_DEVIATION 1.5 • n=5 Participants	37.1 years STANDARD_DEVIATION 1.5 • n=7 Participants	37.2 years STANDARD_DEVIATION 0.1 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI (kg/m2)	30 kg / m2 STANDARD_DEVIATION 2.5 • n=5 Participants	31 kg / m2 STANDARD_DEVIATION 1.8 • n=7 Participants	30.5 kg / m2 STANDARD_DEVIATION 0.2 • n=5 Participants
Day 3 FSH (IU/L)	8 IU/L STANDARD_DEVIATION 1.1 • n=5 Participants	7.6 IU/L STANDARD_DEVIATION 1.1 • n=7 Participants	7.8 IU/L STANDARD_DEVIATION 0.1 • n=5 Participants
Duration of infertility	5.1 years STANDARD_DEVIATION 1.5 • n=5 Participants	5.7 years STANDARD_DEVIATION 1.5 • n=7 Participants	5.4 years STANDARD_DEVIATION 0.1 • n=5 Participants

Timeframe: 12 months

Outcome measures
Measure	Minidose Long Protocol n=27 Participants Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle. Decapeptyl: half the dose of Gn agonist	Microdose Flare Protocol n=28 Participants Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's Decapeptyl: half the dose of Gn agonist
Number of Oocytes Retrieved	4 oocytes Standard Deviation 1	3.4 oocytes Standard Deviation 0.7

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

Serious adverse events
Measure	Minidose Long Protocol Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle. Decapeptyl: half the dose of Gn agonist	Microdose Flare Protocol Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's Decapeptyl: half the dose of Gn agonist
Endocrine disorders ovarian hyperstimulation	— 0/0	— 0/0

Adverse event data not reported

Kasr El-Aini Hospital

Phone: 0223654060