Plain English Summary
Background and study aims
Controlled ovarian hyperstimulation is a technique used in assisted reproduction (e.g. IVF) where fertility drugs are used to induce the release of eggs from the ovaries. Poor ovarian response to controlled ovarian stimulation is a major concern in assisted reproduction. The use of GnRH agonist and antagonist drugs has proved to be effective at improving pregnancy rates in poor responders. However, various studies have reported conflicting results regarding which is superior in this category of patients, and more research is needed in this area. Therefore the aim of this study is to compare the effectiveness of a flexible GnRH antagonist treatment versus a low dose (minidose) long GnRH agonist treatment in poor-responder patients undergoing IVF.
Who can participate?
Women undergoing IVF who are poor responders to ovarian stimulation (e.g. developed less than four eggs in previous IVF cycles)
What does the study involve?
Participants are randomly allocated to receive either flexible GnRH antagonist treatment or minidose long GnRH agonist treatment. The participants’ eggs are retrieved and fertilised and the embryos are transferred back into their womb. The pregnancy rate per embryo transferred is compared between the two groups.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Al-Amal Maternity Hospital (Jordan)
When is the study starting and how long is it expected to run for?
January 2009 to October 2010
Who is funding the study?
Al-Amal Maternity Hospital (Jordan)
Who is the main contact?
Dr Raja Al-Karaki
raja_alkaraki@alamalhospital.com
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 (0)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, 05/01/2009 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 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 measure
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 (if study stopped)
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
Al-Amal Maternity Hospital
Amman
11194
Jordan
Sponsor information
Organisation
Al-Amal Maternity Hospital (Jordan)
Sponsor details
Nablus Street
Aldakhliya Circle
Jabal Alhussein
Amman
11194
Jordan
+962 (0)6 5623165
info@alamalhospital.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Al-Amal Maternity Hospital (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
Basic results (scientific)
Publication list