Contact information
Type
Scientific
Primary contact
Prof Mohamed Aboulghar
ORCID ID
Contact details
3 St 161 Hadayek El Maadi
Cairo
11431
Egypt
+20 (0)25 25 49 44
ghar@link.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Infertility patients treated by IVF/ICSI
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Progesterone
Primary outcome measure
Miscarriage rate in the first trimester
Secondary outcome measures
1. Bleeding episodes in the first trimester
2. Adverse reactions to progesterone
Overall trial start date
20/12/2006
Overall trial end date
20/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
400 participants, 200 in each arm
Participant exclusion criteria
Intra-cytoplasmic sperm injection (ICSI) using surgically retrieved sperm.
Recruitment start date
20/12/2006
Recruitment end date
20/06/2007
Locations
Countries of recruitment
Egypt
Trial participating centre
3 St 161 Hadayek El Maadi
Cairo
11431
Egypt
Sponsor information
Organisation
The Egyptian IVF-ET Center (Egypt)
Sponsor details
3 St 161 Hadayek El Maadi
Cairo
11431
Egypt
+20 (0)25 25 49 44
ivf@link.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Internally funded by the Prinicipal Investigator
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18270182
Publication citations
-
Results
Aboulghar MA, Amin YM, Al-Inany HG, Aboulghar MM, Mourad LM, Serour GI, Mansour RT, Prospective randomized study comparing luteal phase support for ICSI patients up to the first ultrasound compared with an additional three weeks., Hum. Reprod., 2008, 23, 4, 857-862, doi: 10.1093/humrep/den012.