Oocyte Cryopreservation Study (Egg Banking)

Cancer Clinical Trial

Official title:

Live Birthrate Following Oocyte Cryopreservation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02396095
• Other study ID #: 808392
• Status: Terminated
• Phase: N/A
• First received: March 17, 2015
• Last updated: March 17, 2015
• Start date: August 2008
• Est. completion date: July 2013

Study information

• Verified date: March 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	University of Pennsylvania, Reproductive Research Unit	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fertilization rates	Fertilization rates in each cohort will be compared.	10 years	No
Other	Perinatal outcomes	Perinatal outcomes in each cohort will be evaluated including birth weight and gestational age at delivery.	10 years	No
Primary	Live birthrate following transfer of embryos created from frozen eggs	Live birthrate following transfer of embryos created from frozen eggs in the setting of: Autologous oocyte cryopreservation in women without cancer vs.autologous oocyte cryopreservation in women with cancer.	10 years	No
Secondary	Oocyte survival rates	The number of oocytes surviving cryopreservation, storage, and thaw will be evaluated.	10 years	No

External Links

•   Oncofertility