Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients

Infertility Clinical Trial

Official title:

Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963079
• Other study ID #: SAIRB 07-0008
• Status: Completed
• Phase: N/A
• First received: August 19, 2009
• Last updated: July 12, 2010
• Start date: July 2007
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Fertility Center of Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in high responders.

Description:

The purpose of this study is to determine if blastocyst transfers in cycles of post-thaw extended culture (PTEC) have different efficacy than transfers of fresh blastocysts in patients with expected high response to ovarian stimulation.

Multiple studies have found altered endometrial histology and gene expression following controlled ovarian stimulation.

PTEC cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. Once thawed, the embryos are cultured to the blastocyst stage before transfer.

In typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do not actually resume and continue development. PTEC ensures the transfer of embryos that resumed development and continued developing at least to the blastocyst stage (4-5 days post-thaw).

The viability of a blastocyst in a PTEC cycle has been shown to be on par with that of a fresh blastocyst. Therefore, comparing outcomes of blastocyst transfers in PTEC cycles with that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian stimulation to be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Female patient 18 to 40 years of age seeking their first IVF treatment.

2. Cycle day 3 FSH less than 10.0 IU/l.

3. More than 15 antral follicles observed on ultrasound.

Exclusion Criteria:

1. Failure to follow the protocol.

2. Embryo biopsy.

3. Any prior IVF cycle(s).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Embryo cryopreservation
Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.
• Fresh blastocyst transfer
Fresh blastocyst transfer following cycle of controlled ovarian stimulation.

Locations

Country	Name	City	State
United States	Fertility Center of Las Vegas	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Fertility Center of Las Vegas	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)		7 weeks gestation	No
Secondary	Ongoing pregnancy at 10 weeks gestation		10 weeks	No
Secondary	Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)		7 weeks	No