Trial Review

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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
In our Center of Reproductive Medicine and Biology "Clinic Center Hera", 80% of patients are subjected to cycles with short-controlled ovarian stimulation protocol. The aim of this prospective study was to evaluate, based on our experience, the impact of elevated serum levels of progesterone in the day of human corionic gonadotropin administration on pregnancy rate.
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
[email protected]
Contact person for public queries
Name 37143 0
Dr 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
[email protected]
Contact person for scientific queries
Name 37144 0
Dr 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
[email protected]

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.