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Trial registered on ANZCTR


Registration number
ACTRN12613000082707
Ethics application status
Not yet submitted
Date submitted
17/01/2013
Date registered
22/01/2013
Date last updated
22/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The importance of progesterone level at day of human chorionic gonadotropin (hCG) administration on pregnancy rate in the short-term protocol
Scientific title
Evaluation of relationship between progesterone level at the day of human chorionic gonadotropin administration and pregnancy rate.
Secondary ID [1] 281796 0
Nil known
Universal Trial Number (UTN)
U1111-1138-6372
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women with primary idiopatic infertility or miscarriage 288122 0
Condition category
Condition code
Reproductive Health and Childbirth 288497 288497 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The ovarian stimulation protocol used has foreseen the intramuscular administration from the first day of the menstrual cycle of Triptorelin 0.1 mg / ml rFSH and until the day of HCG.In all patients was performed by supplementation of the luteal phase progesterone intravaginal 600mg daily
Intervention code [1] 286340 0
Not applicable
Comparator / control treatment
Not applicable - Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288656 0
Pregnancy rate.
The clinical pregnancy was assessed by the presence of , the clinical pregnancy was assessed by the presence of serum beta-Human chorionic gonadotropin (beta-hCG) positive after 15 days from the oocyte pick up and display of room gestational with or without fetal heartbeat.
Timepoint [1] 288656 0
At 2 weeks after egg collection for Intracytoplasmic sperm injection (ICSI)
Secondary outcome [1] 300703 0
nil
Timepoint [1] 300703 0
nil

Eligibility
Key inclusion criteria
Patients scheduled for IVF-ICSI cycles with an average age of 35 years with basal FSH values <9 mIU/ml and a BMI normal.
Minimum age
20 Years
Maximum age
38 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
patients with more of 38 years, with basal FSH values >9 mIU/ml and a BMI abnormal.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment outside Australia
Country [1] 4817 0
Italy
State/province [1] 4817 0
Giugliano ( Naples)

Funding & Sponsors
Funding source category [1] 286581 0
Other
Name [1] 286581 0
Clinic Center Hera
Country [1] 286581 0
Italy
Primary sponsor type
Other
Name
Clinic Center Hera
Address
Via Santa Caterina da Siena, 36 - 80014
Country
Italy
Secondary sponsor category [1] 285365 0
None
Name [1] 285365 0
Address [1] 285365 0
Country [1] 285365 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288658 0
Ethics committee address [1] 288658 0
Ethics committee country [1] 288658 0
Italy
Date submitted for ethics approval [1] 288658 0
04/09/2013
Approval date [1] 288658 0
Ethics approval number [1] 288658 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37142 0
Dr Sabatino Russo
Address 37142 0
Via Santa Caterina da Siena, 36 - Giugliano (NA) 80014
Country 37142 0
Italy
Phone 37142 0
+39 081 5067919
Fax 37142 0
Email 37142 0
centrohera@libero.it
Contact person for public queries
Name 37143 0
Antonietta Della Ragione
Address 37143 0
Via Vicinale Fra Giambattista, 9 - Giugliano (NA) 80014
Country 37143 0
Italy
Phone 37143 0
+39 380 4790207
Fax 37143 0
Email 37143 0
antoniettadellaragione@hotmail.com
Contact person for scientific queries
Name 37144 0
Mariangela Palmieri
Address 37144 0
Via Santa Caterina da Siena, 36 - Giugliano (NA) 80014
Country 37144 0
Italy
Phone 37144 0
+39 081 5067919
Fax 37144 0
Email 37144 0
mariangela_palmieri@libero.it

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.