Trial Outcomes & Findings for Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF) (NCT NCT00828191)

NCT ID: NCT00828191

Last Updated: 2013-01-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 800 participants
• Primary outcome timeframe: 10 weeks after treatment start
• Results posted on: 2013-01-31

Participant Flow

Participant milestones

Measure	Progesterone SC Progesterone SC given at a daily dose of 25 mg.	Progesterone Tablets Progesterone vaginal tables 100 mg given twice à day.
Overall Study STARTED	400	400
Overall Study COMPLETED	392	390
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)

Baseline characteristics by cohort

Measure	Progesterone SC n=400 Participants Progesterone SC given at a daily dose of 25 mg.	Progesterone Tablets n=400 Participants Progesterone vaginal tables 100 mg given twice à day.	Total n=800 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	400 Participants n=5 Participants	400 Participants n=7 Participants	800 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	34.3 years STANDARD_DEVIATION 4.4 • n=5 Participants	34.3 years STANDARD_DEVIATION 4.5 • n=7 Participants	34.3 years STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male Female	400 Participants n=5 Participants	400 Participants n=7 Participants	800 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	400 participants n=5 Participants	400 participants n=7 Participants	800 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks after treatment start

Population: All randomized patients were included in the analysis

Outcome measures

Measure	Progesterone SC n=400 Participants Progesterone SC given at a daily dose of 25 mg.	Progesterone Tablets n=400 Participants Progesterone vaginal tables 100 mg given twice à day.
Ongoing Pregnancy Rate	40.8 percentage of randomized patients	43.3 percentage of randomized patients

SECONDARY outcome

Timeframe: 4-5 weeks after treatment start

Population: Patient who had at least one embryo transferred.

Implantation rate was defined as the number of gestational sacs divided by the number of embryos transferred (%). This value was calculated for all the patients who had at least one embryo transferred.

Outcome measures

Measure	Progesterone SC n=392 Participants Progesterone SC given at a daily dose of 25 mg.	Progesterone Tablets n=390 Participants Progesterone vaginal tables 100 mg given twice à day.
Implantation Rate	33.2 percentage of embryos transferred Standard Deviation 42.0	35.1 percentage of embryos transferred Standard Deviation 40.9

SECONDARY outcome

Timeframe: nearly 9 months after treatment start

Population: All randomized patients

Outcome measures

Measure	Progesterone SC n=400 Participants Progesterone SC given at a daily dose of 25 mg.	Progesterone Tablets n=400 Participants Progesterone vaginal tables 100 mg given twice à day.
Delivery Rate	40.5 percentage of randomized patients	42.5 percentage of randomized patients

Adverse Events

Progesterone SC

Serious events: 0 serious events

Other events: 156 other events

Deaths: 0 deaths

Progesterone Tablets

Serious events: 0 serious events

Other events: 161 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Progesterone SC n=400 participants at risk Progesterone SC given at a daily dose of 25 mg.	Progesterone Tablets n=400 participants at risk Progesterone vaginal tables 100 mg given twice à day.
General disorders Injection site bruising	9.2% 37/400 • Number of events 38 None of the patients reported SAE considered as related to study drugs.	0.00% 0/400 None of the patients reported SAE considered as related to study drugs.
General disorders Injection site discomfort	14.2% 57/400 • Number of events 68 None of the patients reported SAE considered as related to study drugs.	0.00% 0/400 None of the patients reported SAE considered as related to study drugs.
General disorders Vaginal discharge	0.00% 0/400 None of the patients reported SAE considered as related to study drugs.	12.5% 50/400 • Number of events 50 None of the patients reported SAE considered as related to study drugs.
Gastrointestinal disorders Abdominal discomfort	5.2% 21/400 • Number of events 25 None of the patients reported SAE considered as related to study drugs.	7.0% 28/400 • Number of events 35 None of the patients reported SAE considered as related to study drugs.
Gastrointestinal disorders Constipation	3.0% 12/400 • Number of events 13 None of the patients reported SAE considered as related to study drugs.	5.8% 23/400 • Number of events 23 None of the patients reported SAE considered as related to study drugs.
Nervous system disorders Headache	7.0% 28/400 • Number of events 31 None of the patients reported SAE considered as related to study drugs.	9.0% 36/400 • Number of events 37 None of the patients reported SAE considered as related to study drugs.
Reproductive system and breast disorders Breast pain/tenderness	4.2% 17/400 • Number of events 17 None of the patients reported SAE considered as related to study drugs.	10.5% 42/400 • Number of events 44 None of the patients reported SAE considered as related to study drugs.
Reproductive system and breast disorders vaginal hemorrage	7.0% 28/400 • Number of events 30 None of the patients reported SAE considered as related to study drugs.	7.5% 30/400 • Number of events 34 None of the patients reported SAE considered as related to study drugs.

Additional Information

IBSA U.S. Agent

IBSA Institut Biochimique SA

Phone: 805 376 00 78

Email: cejtwsxx@verizon.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place