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

Fertility Center of Las Vegas (FCLV)

Status: Completed

Conditions: Infertility

Treatments: Procedure: Embryo cryopreservation; Procedure: Fresh blastocyst transfer

Study type: Interventional

Funder types: Industry

Identifiers

NCT00963079

SAIRB 07-0008

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Blastocyst transfer in PTEC cycle

Experimental group

Description:

Transfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC).

Treatment:

Procedure: Embryo cryopreservation

Fresh blastocyst transfer

Active Comparator group

Description:

Transfer of two fresh autologous blastocysts following controlled ovarian stimulation.

Treatment:

Procedure: Fresh blastocyst transfer