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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00963625
Enrollment
100
Registered
2009-08-21
Start date
2007-10-31
Completion date
2010-10-31
Last updated
2010-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Blastocyst transfer, endometrial receptivity, IVF, in vitro fertilization, embryo cryopreservation

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.

Interventions

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

Fresh blastocyst transfer following cycle of controlled ovarian stimulation.

Sponsors

Ferring Pharmaceuticals
CollaboratorINDUSTRY
Fertility Center of Las Vegas
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation)7 weeks gestation

Secondary

MeasureTime frame
Ongoing pregnancy at 10 weeks gestation10 weeks gestation
Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts)7 weeks gestation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026