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

ISRCTN ISRCTN88722916
DOI https://doi.org/10.1186/ISRCTN88722916
Secondary identifying numbers N/A
Submission date
28/12/2006
Registration date
25/01/2007
Last edited
15/04/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Mohamed Aboulghar
Scientific

3 St 161 Hadayek El Maadi
Cairo
11431
Egypt

Phone +20 (0)25 25 49 44
Email ghar@link.net

Study information

Study designA prospective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectivesA 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(s)Approval received from the Ethical Committee of the Egyptian IVF Center on the 15th November 2006.
Health condition(s) or problem(s) studiedInfertility patients treated by IVF/ICSI
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Progesterone
Primary outcome measureMiscarriage rate in the first trimester
Secondary outcome measures1. Bleeding episodes in the first trimester
2. Adverse reactions to progesterone
Overall study start date20/12/2006
Completion date20/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants400 participants, 200 in each arm
Key inclusion criteria1. Patients undergoing IVF/intra-cytoplasmic sperm injection (ICSI)
2. Aged less than 39 years
3. Having at least three high quality embryos
Key exclusion criteriaIntra-cytoplasmic sperm injection (ICSI) using surgically retrieved sperm.
Date of first enrolment20/12/2006
Date of final enrolment20/06/2007

Locations

Countries of recruitment

  • Egypt

Study participating centre

3 St 161 Hadayek El Maadi
Cairo
11431
Egypt

Sponsor information

The Egyptian IVF-ET Center (Egypt)
Hospital/treatment centre

3 St 161 Hadayek El Maadi
Cairo
11431
Egypt

Phone +20 (0)25 25 49 44
Email ivf@link.net
Website http://www.egyptianivfcenter.com/
ROR logo "ROR" https://ror.org/035aahr55

Funders

Funder type

Other

Internally funded by the Prinicipal Investigator

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/04/2008 Yes No