Clinical trial NCT01219504: Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)
Official title: Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing IVF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Each Patient is Both Case and Control
1 Embryo Will be Biopsied and 1 Embryo is Not
Keywords: PGD
IVF
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 infertile couples undergoing IVF will be enrolled in the study.

Brief summary: To assess the impact of embryo biopsy on the reproductive potential of human embryos.

Detailed description: This study will recruit patients from the NY/NJ/CT/eastern PA area only.

All patients will undergo an in vitro fertilization (IVF) cycle with hormonal stimulation and an egg retrieval procedure as deemed appropriate for their diagnosis. Following biopsy, the embryos will be transferred. There will be no delay in the time of transfer as no cells will be analyzed prior to transfer.

On day 3 or day 5 of embryo development, all patients will undergo a two (2) embryo transfer. The embryos selected for transfer will be the 2 morphologically best of the embryo cohort. Once selected for transfer, the embryos will be randomized so that one will be biopsied and the other will be transferred without undergoing biopsy. The embryo randomized to biopsy will have a single cell biopsied.

Following delivery, buccal swabs will be collected from infants.

Eligibility criteria: This study will recruit patients from the NY/NJ/CT/eastern PA area only.

Inclusion Criteria:

1. Maximum of one prior failed IVF treatment cycle
2. Female partner less than 35 years of age
3. Normal day 3 FSH level (\<10 miu/mL)
4. Total basal antral follicle count greater than or equal to 12
5. Male partner with greater than 100,000 total motile spermatozoa and at least 1% normal forms
6. Body mass index (BMI) \< or = 32
7. Normal uterine cavity

Exclusion Criteria:

1. Diagnosis of chronic anovulation secondary to polycystic ovarian disease
2. Diagnosis of endometrial insufficiency
3. Clinical indication for pre-implantation genetic diagnosis (PGD) (undergoing IVF with PGD to rule out a known genetic defect)
4. Use of testicular aspiration or biopsy procedures to obtain sperm

Primary outcomes:
measure: Impact of biopsy on pregnancy
timeFrame: 1 year
measure: Impact of biopsy on delivery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Reproductive Medicine Associates of Connecticut
state: Connecticut
city: Morristown
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
city: New York
country: United States
facility: Reproductive Medicine Associates of New York
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Richard T Scott, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scott RT Jr, Upham KM, Forman EJ, Zhao T, Treff NR. Cleavage-stage biopsy significantly impairs human embryonic implantation potential while blastocyst biopsy does not: a randomized and paired clinical trial. Fertil Steril. 2013 Sep;100(3):624-30. doi: 10.1016/j.fertnstert.2013.04.039. Epub 2013 Jun 15.