Trial Outcomes & Findings for Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF) (NCT NCT00827983)

NCT ID: NCT00827983

Last Updated: 2013-01-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 683 participants
• Primary outcome timeframe: 10 weeks after treatment start
• Results posted on: 2013-01-31

Participant Flow

Participant milestones

Measure	Progesterone SC Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)	Progesterone Vaginal Gel Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
Overall Study STARTED	339	344
Overall Study COMPLETED	321	328
Overall Study NOT COMPLETED	18	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

Baseline characteristics by cohort

Measure	Progesterone SC n=339 Participants Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)	Progesterone Vaginal Gel n=344 Participants Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)	Total n=683 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	339 Participants n=5 Participants	344 Participants n=7 Participants	683 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	33.8 years STANDARD_DEVIATION 4.3 • n=5 Participants	33.9 years STANDARD_DEVIATION 4.3 • n=7 Participants	33.8 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	339 Participants n=5 Participants	344 Participants n=7 Participants	683 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 Hungary	64 participants n=5 Participants	64 participants n=7 Participants	128 participants n=5 Participants
Region of Enrollment Germany	24 participants n=5 Participants	23 participants n=7 Participants	47 participants n=5 Participants
Region of Enrollment United Kingdom	46 participants n=5 Participants	45 participants n=7 Participants	91 participants n=5 Participants
Region of Enrollment Switzerland	48 participants n=5 Participants	50 participants n=7 Participants	98 participants n=5 Participants
Region of Enrollment Italy	157 participants n=5 Participants	162 participants n=7 Participants	319 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks after treatment start

Population: ITT population was analysed (i.e. all the randomised patients)

Outcome measures

Measure	Progesterone SC n=339 Participants Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)	Progesterone Vaginal Gel n=344 Participants Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
Ongoing Pregnancy Rate at the End of the Study	27.4 percentage of randomized patient	30.5 percentage of randomized patient

SECONDARY outcome

Timeframe: nearly 9 month after treatment start

Population: all the randomised patients were included in the analysis

Outcome measures

Measure	Progesterone SC n=339 Participants Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)	Progesterone Vaginal Gel n=344 Participants Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
Delivery Rate and Live Birth Rate	26.8 percentage of randomised patients	29.9 percentage of randomised patients

SECONDARY outcome

Timeframe: Four to five weeks after oocytes retrieval

Population: All the patients who had at least one embryo transferred

Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.

Outcome measures

Measure	Progesterone SC n=322 Participants Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)	Progesterone Vaginal Gel n=331 Participants Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
Implantation Rate	22.6 percentage of embryos transferred Standard Deviation 35.0	23.1 percentage of embryos transferred Standard Deviation 33.1

Adverse Events

Progesterone SC

Serious events: 14 serious events

Other events: 168 other events

Deaths: 0 deaths

Progesterone Vaginal Gel

Serious events: 20 serious events

Other events: 157 other events

Deaths: 0 deaths

Serious adverse events

Measure	Progesterone SC n=338 participants at risk Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)	Progesterone Vaginal Gel n=344 participants at risk Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
Gastrointestinal disorders Gastroenteritis	0.30% 1/338 • Number of events 1 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.00% 0/344 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Gastrointestinal disorders Vomiting	0.30% 1/338 • Number of events 1 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.00% 0/344 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Gastrointestinal disorders abdominal pain	0.00% 0/338 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.29% 1/344 • Number of events 1 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	1.5% 5/338 • Number of events 5 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	1.5% 5/344 • Number of events 5 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Psychiatric disorders Abortion threatened	0.89% 3/338 • Number of events 3 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.87% 3/344 • Number of events 4 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.59% 2/338 • Number of events 2 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.00% 0/344 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Reproductive system and breast disorders OHSS	1.2% 4/338 • Number of events 4 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	2.0% 7/344 • Number of events 7 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Reproductive system and breast disorders Ovarian torsion	0.00% 0/338 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.29% 1/344 • Number of events 1 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/338 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.29% 1/344 • Number of events 1 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/338 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.29% 1/344 • Number of events 1 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/338 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.29% 1/344 • Number of events 1 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Surgical and medical procedures Abortion induced	0.00% 0/338 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.29% 1/344 • Number of events 1 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Vascular disorders deep vein thrombosis	0.00% 0/338 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.29% 1/344 • Number of events 1 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.

Other adverse events

Measure	Progesterone SC n=338 participants at risk Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)	Progesterone Vaginal Gel n=344 participants at risk Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
Gastrointestinal disorders Nausea	5.0% 17/338 • Number of events 26 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	4.7% 16/344 • Number of events 34 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Gastrointestinal disorders Abdominal distension	6.5% 22/338 • Number of events 34 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	7.6% 26/344 • Number of events 35 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Gastrointestinal disorders Abdominal pain	5.6% 19/338 • Number of events 33 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	6.4% 22/344 • Number of events 33 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Nervous system disorders Headache	5.3% 18/338 • Number of events 29 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	4.9% 17/344 • Number of events 20 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Respiratory, thoracic and mediastinal disorders Breast tenderness	6.8% 23/338 • Number of events 34 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	6.1% 21/344 • Number of events 22 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Reproductive system and breast disorders Uterine spasm	12.4% 42/338 • Number of events 42 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	17.4% 60/344 • Number of events 60 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Reproductive system and breast disorders vaginal discharge	3.8% 13/338 • Number of events 13 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	17.4% 60/344 • Number of events 60 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Reproductive system and breast disorders vaginal hemorrage	14.2% 48/338 • Number of events 48 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	18.3% 63/344 • Number of events 63 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Reproductive system and breast disorders Vaginal discomfort	0.00% 0/338 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	8.1% 28/344 • Number of events 28 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
General disorders Administration site pain	49.7% 168/338 • Number of events 168 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	7.3% 25/344 • Number of events 25 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
General disorders Administration site pruritus	12.1% 41/338 • Number of events 41 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	9.6% 33/344 • Number of events 33 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
General disorders administration site swelling	10.9% 37/338 • Number of events 37 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	0.29% 1/344 • Number of events 1 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.
Reproductive system and breast disorders Vaginal inflammation	0.00% 0/338 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.	7.6% 26/344 • Number of events 26 • Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months All the patients who received at least one dose of the study drug have been included in the adverse event analysis.

Additional Information

Clinical trial manager

IBSA Institut biochimique

Phone: +41583601000

Email: barbara.cometti@ibsa.ch

Results disclosure agreements

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