Condition category
Pregnancy and Childbirth
Date applied
28/12/2006
Date assigned
25/01/2007
Last edited
15/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.egyptianivfcenter.com/

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18270182

Publication citations

  1. 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.

Additional files

Editorial Notes