Condition category
Pregnancy and Childbirth
Date applied
16/06/2011
Date assigned
29/07/2011
Last edited
04/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Dr Raja Alkaraki

ORCID ID

Contact details

Nablus Street
Aldakhliya Circle
Jabal Alhussein
Amman
11194
Jordan
+962 79 5885100
raja_alkaraki@alamalhospital.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of a flexible GnRH antagonist versus minidose long GnRH agonist in poor-responder patients undergoing IVF - a prospective randomized trial

Acronym

Study hypothesis

The objective of our study was to compare the efficacy of flexible gonadotropin-releasing hormone (GnRH) antagonist protocol versus minidose long GnRH agonist protocol in poor-responder patients undergoing in vitro fertilisation (IVF)

Ethics approval

Institutional Review Board of Al-Amal Maternity Hospital, 5 January 2009 ref: AM/ART/153

Study design

Single center randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Poor ovarian response to ovarian stimulation in IVF

Intervention

1. Random allocation was performed by an IVF physician at the start of the study using consecutive number method in 1:1 ratio
2. In this prospective randomized trial, participants were randomly assigned to receive either flexible GnRH antagonist protocol (n=62) in which Cetrorelix 0.25mg daily was added to the ovarian stimulation when the largest follicle measures ¡Ý14mm or minidose long agonist protocol (n=62) in which Triptoreline 0.05 mg daily (half the standard dose) was initiated during the luteal phase prior the treatment cycle
3. All patients in both groups received the same starting dose (450IU) of Urofollitropin for ovarian stimulation
4. This dose was adjusted after the fifth day of stimulation according to the ovarian response as evaluated by vaginal ultrasonography and measurement of estradiol and progesterone levels
5. When the leading follicle had reached a diameter of 18 mm, ovulation was triggered with 10.000 IU of HCG
6. This was followed by transvaginal ultrasound guided oocyte retrieval 35 hours later
7. In all cycles, ICSI technique was performed and embryo transfers were done 48-72 hours after oocyte retrievals
8. Luteal phase support was provided with vaginal progesterone 400 mg daily starting one day following oocyte retrieval until the day of the pregnancy test, then until 10 weeks of pregnancy if the treatment is successful
9. A serum B-HCG level was performed 15 days after oocyte collection

Intervention type

Drug

Phase

Not Applicable

Drug names

Cetrorelix, Progesterone, Triptoreline, Urofollitropin

Primary outcome measures

The clinical pregnancy rate per embryo transfer

Secondary outcome measures

1. Required gonadotrophin dose
2. Days of stimulation
3. Estradiol on day of human chorionic gonadotropin (HCG)
4. Progesterone on day of HCG
5. Number of oocytes retreived
6. Number of fertilized oocytes
7. Number of embryos obtained
8. Number of embryos transferred

Overall trial start date

10/01/2009

Overall trial end date

30/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Participants were poor responders to ovarian stimulation undergoing IVF program and defined as
1. Women who developed less than four oocytes in previous IVF cycles
2. Women with high basal Follicle-stimulating hormone (FSH) level (>10IU/L)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

124

Participant exclusion criteria

1. Patients with intrauterine pathology (endometrial polyp, intrauterine septum)
2. Patients with polycystic ovaries
3. Patients with ovarian cyst, detected on second day of cycle (baseline evaluation)

Recruitment start date

10/01/2009

Recruitment end date

30/10/2010

Locations

Countries of recruitment

Jordan

Trial participating centre

Nablus Street
Amman
11194
Jordan

Sponsor information

Organisation

Al-Amal Maternity Hospital (Jordan)

Sponsor details

Nablus Street
Aldakhliya Circle
Jabal Alhussein
Amman
11194
Jordan
+962 6 5623165
info@alamalhospital.com

Sponsor type

Hospital/treatment centre

Website

http://www.alamalhospital.com/

Funders

Funder type

Hospital/treatment centre

Funder name

Al-Amal Maternity Hospital (Amman-Jordan)

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

Publication citations

Additional files

Editorial Notes