Clinical trial NCT01223118: Evaluation of the Impact of Vitrification on Oocytes
Official title: Evaluation of the Impact of Vitrification on the Reproductive Performance and Potential of Human Oocytes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertilization
Keywords: Oocyte
vitrification
IVF
PGD
embryo biopsy
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.

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

Cryopreservation of human oocytes has a great potential to preserve or extend fertility in the face of disease whose treatment would result in a loss of ovarian function. (malignancy, severe autoimmune disease, etc.). It would also provide a means of quarantining oocytes to be used in oocyte donation to provide the lowest possible risk of infection.

There are two methods for storage of oocytes: slow freezing or vitrification. Slow freezing is the conventional method and has been successfully used for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. However, the technique has not been rigorously validated to date. The aim of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.

Patients will undergo ovarian stimulation for in vitro fertilization (IVF) according to the protocol recommended by their primary doctor. After retrieval, mature oocytes will be divided in half. One half will undergo vitrification, immediate thaw and intracytoplasmic sperm injection (ICSI). The other half will undergo just ICSI. All embryos will then develop on identical culture until day 3 or day 5. Prior to transfer, the best embryo from each group will undergo biopsy for genetic fingerprinting. The patient will have a 2 embryo transfer (one from each group). All extra embryos will be biopsied for pre-implantation genetic diagnosis (PGD) prior to being cryopreserved. If the patient becomes pregnant, we will follow up with an additional blood draw at approximately 9 weeks gestation and buccal swabs after the delivery of the infant(s).

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

Inclusion Criteria:

1. No prior failed IVF treatment cycle
2. Female partner less than 35 years of age at time of onset of the IVF cycle
3. Normal maximum prior day 3 follicle stimulating hormone (FSH) level (\< or = 10 IU/L)
4. Total basal antral follicle count greater than or equal to 12
5. Male partner with greater than 100,000 total motile spermatozoa Donor sperm is acceptable but the couples will be required to provide one additional vial for DNA analysis
6. Body Mass Index (BMI) ≤ 32 kg/m2

Exclusion Criteria:

1. Diagnosis of chronic oligoovulation or anovulation (cycle typically occurring less often than every 38 days)
2. Diagnosis of endometrial insufficiency
3. Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)
4. Use of testicular aspiration or biopsy procedures to obtain sperm
5. Unevaluated ovarian mass
6. Presence of hydrosalpinges which communicate with the endometrial cavity
7. Any contraindication to undergoing in vitro fertilization or gonadotropin stimulation

Primary outcomes:
measure: Aneuploidy Rate (evaluation of whether embryo is chromosomally normal)
timeFrame: 1 year
Secondary outcomes:
measure: Delivery rates
timeFrame: 1 year
measure: Paired Sustained Implantation Rate (number of viable fetuses beyond the first trimester per embryo transferred)
timeFrame: 1 year
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
city: Allentown
country: United States
facility: Reproductive Medicine Assoicates of PA at Lehigh Valley
state: Pennsylvania
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Richard T Scott, MD
role: PRINCIPAL_INVESTIGATOR
References: