Clinical trial NCT02396095: Oocyte Cryopreservation Study (Egg Banking)
Official title: Live Birthrate Following Oocyte Cryopreservation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Keywords: female
cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Penn Fertility Care

Brief summary: Women of reproductive age who seek to freeze eggs for future pregnancy attempts may be eligible to participate in a study investigating pregnancies that result from frozen eggs.

Detailed description: Participants follow standard fertility protocols to stimulate the growth of multiple egg follicles. When the egg follicles are mature, the eggs will be removed under sedation, examined by an embryologist under a microscope and the mature eggs will be immediately frozen and kept frozen in tanks at Penn Fertility Care using the same methods of labeling and quality assurance currently in place for frozen embryos.

Eggs will be thawed in the future when the participant wishes to attempt pregnancy and fertilized by standard methods used during In Vitro Fertilization (IVF). Resulting embryos will be placed into the uterus by a procedure that will require approximately 15-30 minutes. The number of embryos to be transferred will be dictated by standard clinical practice. After embryo transfer, subjects will return for serum pregnancy tests at 14 days after the embryo transfer. For those who are not pregnant, there will be no further participation in the study. For those who do achieve pregnancy, trans-vaginal ultrasound will be performed at approximately 6 weeks gestation and weekly thereafter until 8 weeks gestation at which time, they will be referred to their general obstetrician for prenatal care. Participants will be asked to provide the study team with information about birthweight, height, length, gestational age at delivery, complications at delivery, and infant number. This information is routinely collected from patients undergoing conventional IVF in order to maintain quality assurance as recommended by the American Society of Reproductive Medicine. Information will also be collected from the participant's medical records including physical characteristics, medical and fertility history, semen analysis of the partner if appropriate, egg stimulation characteristics including medications, days of stimulation, number of egg follicles, number of mature and immature eggs retrieved, number of eggs frozen, number of eggs thawed, number of embryos, disposition of embryos, pregnancy test results, number of pregnancies that survived the first 12 weeks and prenatal screening tests.

Eligibility criteria: Inclusion Criteria:

* age between 15 and 45
* desire oocyte cryopreservation or use of cryopreserved oocytes for the purposes of achieving pregnancy
* willingness to participate in study and provide informed consent

Exclusion Criteria:

* day 3 FSH over 20 mIU/ml, or Day 3 E2 over 100pg/ml
* ovarian cyst greater than 14mm at baseline ultrasound
* uncontrolled medical illness such as diabetes, hypertension, or cardiovascular disease
* current pregnancy

Primary outcomes:
measure: Live birthrate following transfer of embryos created from frozen eggs
timeFrame: 10 years
Secondary outcomes:
measure: Oocyte survival rates
timeFrame: 10 years
Other outcomes:
measure: Fertilization rates
timeFrame: 10 years
measure: Perinatal outcomes
timeFrame: 10 years
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, Reproductive Research Unit
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Clarisa R Gracia, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: