Condition category
Pregnancy and Childbirth
Date applied
30/12/2011
Date assigned
15/03/2012
Last edited
23/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 partner’s 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 measures

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

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

http://www.hurleymc.com/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22960769

Publication citations

  1. 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.

Additional files

Editorial Notes