|
ISRCTN
|
ISRCTN88722916
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Prospective randomised study comparing luteal phase support in in-vitro fertilisation/intracytoplasmic sperm injection patients for three weeks versus seven weeks from day of positive pregnancy test
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
A question was sent to 18 in-vitro fertilisation (IVF) centres worldwide, asking about their policy of luteal phase support. A very wide variation in the duration of luteal phase support was noticed between different centres. The study will compare three weeks versus seven weeks of luteal phase support from day of positive beta-human chorionic gonadotropin (β-hCG) in IVF patients.
|
|
Ethics approval
|
Approval received from the Ethical Committee of the Egyptian IVF Center on the 15th November 2006.
|
|
Study design
|
A prospective randomised controlled trial
|
|
Countries of recruitment
|
Egypt
|
|
Disease/condition/study domain
|
Infertility patients treated by IVF/ICSI
|
|
Participants - inclusion criteria
|
1. Patients undergoing IVF/intra-cytoplasmic sperm injection (ICSI)
2. Aged less than 39 years
3. Having at least three high quality embryos
|
|
Participants - exclusion criteria
|
Intra-cytoplasmic sperm injection (ICSI) using surgically retrieved sperm.
|
|
Anticipated start date
|
20/12/2006
|
|
Anticipated end date
|
20/06/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
400 participants, 200 in each arm
|
|
Interventions
|
All patients receive intramuscular (IM) progesterone 50 mg daily from day of oocyte retrieval and continue for three weeks from day of positive β-hCG test, i.e. day of first ultrasound.
Patients are randomised on day of first ultrasound to:
Arm one: stop luteal phase support on day of first ultrasound
Arm two: continue luteal phase support in the form of cyclogest (micronised progesterone 400 mg) for four more weeks.
|
|
Primary outcome measure(s)
|
Miscarriage rate in the first trimester
|
|
Secondary outcome measure(s)
|
1. Bleeding episodes in the first trimester
2. Adverse reactions to progesterone
|
|
Sources of funding
|
Internally funded by the Prinicipal Investigator
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/pubmed/18270182
|
|
Contact name
|
Prof
Mohamed
Aboulghar
|
|
Address
|
3 St 161 Hadayek El Maadi
|
|
City/town
|
Cairo
|
|
Zip/Postcode
|
11431
|
|
Country
|
Egypt
|
|
Tel
|
+20 (0)25 25 49 44
|
|
Fax
|
+20 (0)23 38 30 49
|
|
Email
|
ghar@link.net
|
|
Sponsor
|
The Egyptian IVF-ET Center (Egypt)
|
|
Address
|
3 St 161 Hadayek El Maadi
|
|
City/town
|
Cairo
|
|
Zip/Postcode
|
11431
|
|
Country
|
Egypt
|
|
Tel
|
+20 (0)25 25 49 44
|
|
Email
|
ivf@link.net
|
|
Sponsor website:
|
http://www.egyptianivfcenter.com/
|
|
Date applied
|
28/12/2006
|
|
Last edited
|
15/04/2008
|
|
Date ISRCTN assigned
|
25/01/2007
|
