Plain English Summary
Background and study aims
Couples trying to start a family sometimes encounter difficulties in fulfilling the dream. In-vitro fertilization and embryo transfer (IVF-ET) (test tube baby) was introduced 30 years ago. It has since helped many infertile couples in enjoying parenthood. Over the last 20 years the results of IVF-ET have improved dramatically, but the risk of multiple pregnancies has also increased. There is now a trend among infertility specialists to transfer fewer embryos to reduce the occurrence of multiple pregnancies. Over the last 10 years most infertility clinics have transferred only two embryos in women who are less than 35 years old. Physicians in many European countries and in some clinics in North America have been transferring one embryo in certain patients without reducing pregnancy chances. The aim of this study is to decrease the occurrence of multiple pregnancies without decreasing the chances of getting pregnant. In this study we will compare the chances of pregnancy, miscarriage, delivery and multiple pregnancies between two groups of participating patients. This is to determine if transferring only one embryo would affect your chances of getting pregnant compared to transferring two embryos. The embryos will be transferred back to your womb five days after obtaining the eggs at a stage of embryo development called the blastocyst stage, providing the blastocysts are of good quality.
Who can participate?
You are eligible for this study if you are infertile, no matter what the reason is for your infertility. You need to be 18-35 years old with a good supply of eggs, as determined by certain blood tests, and without problems in your womb that could interfere with pregnancy. In addition, you should not have undergone more than two failed IVF-ET cycles in the past.
What does the study involve?
During this study you and all other participants will receive the same treatment (fertility medications) to get you to produce several eggs, which will be retrieved from your uterus by a simple surgery after you have been given medication to help you fall asleep very briefly. Your eggs will be fertilized with your partners sperm and the embryos will be observed in the laboratory for five days. If two or more of your embryos reach the blastocyst stage and are of good quality, you will continue with the study. Otherwise, you will be dropped out of the study and the number of embryos to be transferred to you will depend on the quality of your embryos and your particular situation. This will be determined by the physician performing your embryo transfer after consulting with you and your partner. If you continue with the study, you will be randomly assigned to one of two groups. If you are in group 1 you will have one blastocyst transferred back to the uterus. If you are in group 2 you will have two blastocysts transferred. After two weeks a pregnancy test will determine whether you are pregnant or not. If you are pregnant, an ultrasound scan will be done two weeks after your positive pregnancy test to determine if the pregnancy is good and to see if there is more than one baby. A second ultrasound scan will be done after one to two weeks and after that you will be transferred to the care of you obstetrician.
What are the possible benefits and risks of participating?
There are no direct benefits from participating in the study. However, patients participation may help in the advancement of science by finding out the benefit of avoiding multiple pregnancies with all its obstetric, neonatal, developmental and financial consequences. The sponsor, Ferring Pharmaceuticals, Inc., is partially providing medications in addition to a limited grant that helps to off-set some of the costs related to the study and also helps to reduce the cost to you for undergoing a cycle of IVF-ET. Some studies say that the chances of pregnancy after the transfer of only one blastocyst may be decreased by 5-10%. Other studies say that the chances of getting pregnant will not be decreased. In fact, the American Society of Reproductive Medicine recommends transferring one blastocyst in favorable circumstances. There are often potential risks and complications associated with IVF in general. Those risks and complications are listed in the consent form. The risks of those procedures are detailed especially in the IVF-ET consent forms, including the consent form for ovarian stimulation, consent form for in vitro fertilization and consent form for embryo transfer.
Where is the study run from?
Hurley Medical Center (MI, USA).
When is study starting and how long is it expected to run for?
The study ran from October 2008 to November 2013.
Who is funding the study?
The study is sponsored by Ferring Pharmaceutical Company. The company will be partially providing you with the medications you need while going through IVF. In addition, IVF Michigan is offering you a 50% discount on the cost of the procedure.
Who is the main contact?
Sheryl Benford-Loyer, RN
810-262-9714 (Flint, Michigan)
248-844-8845 (Rochester Hills, Michigan)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mostafa Abuzeid
ORCID ID
Contact details
Hurley Medical Center
Suite 209
Two Hurley Plaza
Flint
MI 48532
United States of America
+1 810 262 9714
reprod1@hurleymc.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
190454-4
Study information
Scientific title
Comparing the results of one blastocyst transfer versus two in good prognosis patients going through in vitro fertilisation (IVF) with intra cytoplasmic sperm injections (ICSI) and embryo transfer (ET): a prospective, randomized study.
Acronym
Study hypothesis
Null hypothesis: no statistical difference in pregnancy rates between the transfer of one blastocyst versus two blastocysts.
On 23/01/2014 the anticipated end date was changed from 29/08/2012 to 02/11/2013.
Ethics approval
Hurley Medical Center Institutional Review Board, 28/10/2008 (reviewed 30/08/2011), ref: 190452-4
Study design
Prospective randomized study
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
Infertility
Intervention
Patients are randomised to either one of the two groups:
1. Receive one embryo
2. Receive two embryos
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Pregnancy rate
Secondary outcome measures
1. Implanation rate
2. Delivery rate
3. Miscarriage rate
Overall trial start date
28/10/2008
Overall trial end date
02/11/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients going through a cycle of IVF/ET
2. Have signed a consent form
3. Age 18 - 35 years old
4. Follicle-stimulating hormone (FSH) level on cycle day 2 or 3 < 10
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant exclusion criteria
1. Day 2 or 3 FSH level > 10
2. Previous history of poor response to stimulation drugs
3. Previous history of more than one failed IVF cycle
Recruitment start date
28/10/2008
Recruitment end date
02/11/2013
Locations
Countries of recruitment
United States of America
Trial participating centre
Hurley Medical Center
Flint
MI 48532
United States of America
Sponsor information
Organisation
Hurley Medical Center (USA)
Sponsor details
c/o Dr Mostafa I Abuzeid
Suite 209
Two Hurley Plaza
Flint
MI 48532
United States of America
+1 810 262 9714
reprod1@hurleymc.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
IVF Michigan (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ferring Pharmaceuticals Inc (USA)
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22960769
Publication citations
-
Results
Abuzeid MI, Mitwally M, Abuzeid YM, Bokhari HA, Ashraf M, Diamond MP, Early initiation of gonadotropin-releasing hormone antagonist in polycystic ovarian syndrome patients undergoing assisted reproduction: randomized controlled trial ISRCTN69937179., J. Assist. Reprod. Genet., 2012, 29, 11, 1193-1202, doi: 10.1007/s10815-012-9850-7.