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 |
| Protocol serial number | N/A |
| Sponsor | The Egyptian IVF-ET Center (Egypt) |
| Funder | Internally funded by the Prinicipal Investigator |
- 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
Scientific
3 St 161 Hadayek El Maadi
Cairo
11431
Egypt
| Phone | +20 (0)25 25 49 44 |
|---|---|
| ghar@link.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Approval received from the Ethical Committee of the Egyptian IVF Center on the 15th November 2006. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Progesterone |
| Primary outcome measure(s) |
Miscarriage rate in the first trimester |
| Key secondary outcome measure(s) |
1. Bleeding episodes in the first trimester |
| Completion date | 20/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 400 |
| Key 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 |
| Key exclusion criteria | Intra-cytoplasmic sperm injection (ICSI) using surgically retrieved sperm. |
| Date of first enrolment | 20/12/2006 |
| Date of final enrolment | 20/06/2007 |
Locations
Countries of recruitment
- Egypt
Study participating centre
3 St 161 Hadayek El Maadi
Cairo
11431
Egypt
11431
Egypt
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
