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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: Embryo cryopreservation; Procedure: Fresh blastocyst transfer

• Registration Number: NCT00963625
• Lead Sponsor: Fertility Center of Las Vegas

Brief Summary

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

Detailed 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 normal 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-08
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Female patient 18 to 40 years of age seeking their first IVF treatment.
• Cycle day 3 FSH less than 10.0 IU/l.
• 8 to 15 antral follicles observed on ultrasound.

Exclusion Criteria

• Failure to follow the protocol.
• Embryo biopsy.
• Any prior IVF cycle(s).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blastocyst transfer in PTEC cycle	Embryo cryopreservation	Transfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC).
Fresh blastocyst transfer.	Fresh blastocyst transfer	Transfer of two fresh autologous blastocysts following controlled ovarian stimulation.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)	7 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy at 10 weeks gestation	10 weeks gestation
Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)	7 weeks gestation

Trial Locations

Locations (1)

Fertility Center of Las Vegas; 🇺🇸 Las Vegas, Nevada, United States