Condition category
Urological and Genital Diseases
Date applied
14/12/2005
Date assigned
28/02/2006
Last edited
24/08/2009
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
Street 161
Hadayek El Maadi
Cairo
11431
Egypt
+20 2525 4944
ghar@link.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Gonadotropin-Releasing Hormone (GnRH) antagonist has a direct impact on granulosa cells reducing estradiol (E2) production, thus may reduce incidence of severe OHSS

Ethics approval

Approved by the Institutional review board, August 2005

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Ovarian Hyperstimulation Syndrome (OHSS)

Intervention

GnRH antagonist versus coasting (care as usual)

Intervention type

Drug

Phase

Not Specified

Drug names

GnRH antagonist

Primary outcome measures

Current information as of 24/08/09:
High quality embryos

Initial information at time of registration:
OHSS

Secondary outcome measures

Current information as of 24/08/09:
1. Days of intervention
2. Number of oocytes
3. Pregnancy rate
4. Number of cryopreserved embryos
5. Incidence of severe OHSS

Initial information at time of registration:
Pregnancy rate

Overall trial start date

30/11/2005

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Women undergoing in vitro fertilisation (IVF) or IntraCytoplasmic Sperm Injection (ICSI) trial down regulated with GnRH agonist and at risk of severe OHSS

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

216 (108 - antagonist; 108 - coasting)

Participant exclusion criteria

1. Women above 39 years old
2. Medical illness

Recruitment start date

30/11/2005

Recruitment end date

01/06/2006

Locations

Countries of recruitment

Egypt

Trial participating centre

3, Street 161
Cairo
11431
Egypt

Sponsor information

Organisation

The Egyptian IVF-ET Centre (Egypt)

Sponsor details

3
Street 161
Hadayek El Maadi
Cairo
11431
Egypt
+20 (0)2 5254944
ghar@link.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The Egyptian IVF-ET center

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17854523

Publication citations

  1. Results

    Aboulghar MA, Mansour RT, Amin YM, Al-Inany HG, Aboulghar MM, Serour GI, A prospective randomized study comparing coasting with GnRH antagonist administration in patients at risk for severe OHSS., Reprod. Biomed. Online, 2007, 15, 3, 271-279.

Additional files

Editorial Notes