Status:
COMPLETED
Single Embryo Transfer of a Euploid Embryo Versus Double Embryo Transfer
Lead Sponsor:
Reproductive Medicine Associates of New Jersey
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
All Genders
18-43 years
Phase:
NA
Brief Summary
This study seeks to compare the pregnancy and delivery rates of patients who undergo a single embryo transfer, when the embryo has been tested and determined to be chromosomally normal, with pregnancy...
Detailed Description
This study will recruit patients from the NJ/NY/CT/eastern PA area only. Twin and higher-order multiple pregnancies are the most common and most significant complication of pregnancies conceived thro...
Eligibility Criteria
Inclusion
- Maximum of one (1) prior failed IVF cycle (a failed cycle is any cycle that did not deliver. Pregnancy losses are failed cycles. Ok to participate as a recipient in an egg donor cycle.)
- Female partner less than 43 years old at time of onset of IVF cycle
- Maximum prior day 3 follicle stimulation hormone (FSH) level of 12 (in RMA NJ laboratory)
- Minimum anti-mullerian hormone (AMH)of 1.2 within 1 year
- Normal uterine cavity demonstrated by saline sonogram, hysterosalpingogram or hysteroscopy within 1 year.
- Male partner with greater than 100,000 total motile spermatozoa. Donor sperm ok.
- Body Mass Index (BMI) less than or equal to 30 kg/m2.
Exclusion
- Diagnosis of chronic anovulation (cycles typically longer than 90 days)
- Diagnosis of endometrial insufficiency- prior cycle with endometrial thickness less than 6mm, abnormal endometrial echotexture, persistent endometrial fluid.
- Clinical indication of aneuploidy screening (i.e. history of loss of chromosomally abnormal pregnancies)
- Clinical indication for PGD for single-gene disorder (i.e. PGD is needed to select against the transfer of embryos affected with a specific condition)
- Use of testicular aspiration or biopsy procedures to obtain sperm
- Unevaluated ovarian mass or surgically confirmed stage IV endometriosis
- Presence of hydrosalpinges which communicate with the endometrial cavity
- Any contraindication to undergoing in vitro fertilization
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT01408433
Start Date
August 1 2011
End Date
December 1 2014
Last Update
March 26 2015
Active Locations (2)
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1
Reproductive Medicine Associated of New Jersey
Morristown, New Jersey, United States, 07960
2
Reproductive Medicine Associated of Pennsylvania at lehigh Valley
Allentown, Pennsylvania, United States, 18104