Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201512000952372 Date of Approval: 30/11/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title hCG luteal support after Triptorelin trigger in IVF
Official scientific title Does hCG Luteal Support Improve Pregnancy Rates in IVF Cycles with Cetrorelix Down-regulation and Triptorelin Triggering?
Brief summary describing the background and objectives of the trial Patients undergoing IVF cycles using the antagonist protocol (e.g. Cetrorelix) could receive Triptorelin as a trigger injection to reduce the incidence of ovarian hyper-stimulation syndrome (OHSS). This could possibly decrease pregnancy rates. Luteal phase support using hCG could, however, improve pregnancy rates on the expense of higher incidence of OHSS. No RCT until now has addressed this issue.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infertility,Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2014
Actual trial start date 01/12/2014
Anticipated date of last follow up 01/06/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 170
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Sealed opaque envelopes Sealed opaque envelopes, opened after recruitment Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Giving hCG 1500 Units Once Injection 85
Control Group Control group None None None 85
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who received Cetrorelix for down-regulation AND Triptorelin as a trigger injection AND from whom < 25 cumulus masses were retrieved Presence of significant symptoms and / or signs of OHSS on day of ovum pick-up (OPU), e.g. significant nausea, vomiting, shortness of breath, abdominal pain, fluid in pouch of Douglas (PoD) or abdominal distension. BMI < 19 kg/m2 Past history of OHSS 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/10/2014 Adam Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
20 Aden street, Mohandeseen Giza 12411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Chemical pregnancy rate 2 weeks after embryo transfer
Secondary Outcome Clinical pregnancy rate 4 weeks after embryo transfer
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Adam International Hospital 20 Aden street, Mohandeseen Giza 12411 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Adam international Hospital 20 Aden street, Mohandeseen Giza 12411 Egypt
Adam International Hospital 20 Aden street, Mohandeseen Giza 12411 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adam International Hospital 20 Aden street, Mohandeseen Giza 12411 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof. Hossam Fahem Abdel-Rahim 10 El-Zahraa street, Dokki Giza 12311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hossam Abdel-Rahim hossam_fahem@hotmail.com +201227708226 10 El-Zahraa street, Dokki
City Postal code Country Position/Affiliation
Giza 12311 Egypt Professor of OB/GYN
Role Name Email Phone Street address
Principal Investigator Hossam Abdel-Rahim hossam_fahem@hotmail.com +201227708226 10 El-Zahraa street, Dokki
City Postal code Country Position/Affiliation
Giza 12311 Egypt Professor of OB/GYN
Role Name Email Phone Street address
Public Enquiries Hossam Abdel-Rahim hossam_fahem@hotmail.com +201227708226 10 El-Zahraa street, Dokki
City Postal code Country Position/Affiliation
Giza 12311 Egypt Professor of OB/GYN
Role Name Email Phone Street address
Scientific Enquiries Hossam Abdel-Rahim hossam_fahem@hotmail.com +201227708226 10 El-Zahraa street, Dokki
City Postal code Country Position/Affiliation
Giza 12311 Egypt Professor of OB/GYN
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information