Trial Outcomes & Findings for Early Progesterone Cessation After in Vitro Fertilization (NCT NCT01177904)
NCT ID: NCT01177904
Last Updated: 2024-04-08
Results Overview
Number of bleeding episodes up to a year
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Up to year
Results posted on
2024-04-08
Participant Flow
Progesterone during 1st trimester
Participant milestones
| Measure |
Progesterone 5 Weeks
The study group stop receiving progesterone on the day of their first Ultra-sound at 5 weeks pregnancy
Cease progesterone at 5: Cease administration of progesterone at first Ultra-sound at 5 weeks
|
Control Group : Progesterone 8 Weeks
Progesterone will be given until 8 weeks of pregnancy
control group: progesterone 8: Control group: progesterone until 8 weeks of pregnancy
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Progesterone Cessation After in Vitro Fertilization
Baseline characteristics by cohort
| Measure |
Progesterone 5 Weeks
n=100 Participants
The study group of women stop receiving P4 on the day of their first US at 5 weeks pregnancy
Cease progsterone at 5: Cease administration of progsterone at first US at 5 weeks
|
Control Group : P4 8 Weeks
n=100 Participants
Progesterone will be given until 8 weeks of pregnancy
control group: progesterone 8: Control group: progesterone until 8 weeks of pregnancy
|
Total
n=200 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
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 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
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Bleeding Episodes
|
8 Bleeding episodes
STANDARD_DEVIATION 4 • n=5 Participants
|
8 Bleeding episodes
STANDARD_DEVIATION 4 • n=7 Participants
|
8 Bleeding episodes
STANDARD_DEVIATION 4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to yearNumber of bleeding episodes up to a year
Outcome measures
| Measure |
Control Group : P4 8 Weeks
n=100 Participants
Progesterone will be given until 8 weeks of pregnancy
control group: progesterone 8: Control group: progesterone until 8 weeks of pregnancy
|
Study Group
n=100 Participants
The study group stop receiving progesterone on the day of their first Ultra-sound at 5 weeks pregnancy
Cease progesterone at 5: Cease administration of progesterone at first Ultra-sound at 5 weeks
|
|---|---|---|
|
Number of Bleeding Episodes
|
8 Episodes of bleeding
Standard Deviation 10
|
8 Episodes of bleeding
Standard Deviation 10
|
Adverse Events
Control Group : P4 8 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study Group: P4 5 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place