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OpenTrials
Completed

NCT Number: NCT00963079

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fertility Center of Las Vegas

Las Vegas, Nevada, 89117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • More than 15 antral follicles observed on ultrasound.

Exclusion criteria

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

Treatment and study plan

Embryo cryopreservation

Procedure

Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.

Fresh blastocyst transfer

Procedure

Fresh blastocyst transfer following cycle of controlled ovarian stimulation.

Primary outcomes

  1. Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)

    Time frame: 7 weeks gestation

Secondary outcomes

  1. Ongoing pregnancy at 10 weeks gestation

    Time frame: 10 weeks

  2. Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)

    Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

Fertility Center of Las Vegas

Industry

Collaborators

  • Schering-Plough

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 21, 2009
Registry last updated
Jul 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.