Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
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Purpose
This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.
| Condition | Intervention |
|---|---|
|
Infertility |
Procedure: Embryo cryopreservation Procedure: Fresh blastocyst transfer |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients |
- Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) [ Time Frame: 7 weeks gestation ] [ Designated as safety issue: No ]
- Ongoing pregnancy at 10 weeks gestation [ Time Frame: 10 weeks gestation ] [ Designated as safety issue: No ]
- Implantation rate (ratio of the number of fetal heart tones to the number of transferred blastocysts) [ Time Frame: 7 weeks gestation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2007 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Blastocyst transfer in PTEC cycle
Transfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC).
|
Procedure: Embryo cryopreservation
Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.
|
|
Active Comparator: Fresh blastocyst transfer.
Transfer of two fresh autologous blastocysts following controlled ovarian stimulation.
|
Procedure: Fresh blastocyst transfer
Fresh blastocyst transfer following cycle of controlled ovarian stimulation.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts 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).
Contacts and Locations| United States, Nevada | |
| Fertility Center of Las Vegas | |
| Las Vegas, Nevada, United States, 89117 | |
| Principal Investigator: | Bruce Shapiro, M.D., Ph.D. | Fertility Center of Las Vegas |
More Information
No publications provided by Fertility Center of Las Vegas
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bruce Shapiro, M.D., Ph.D., Fertility Center of Las Vegas |
| ClinicalTrials.gov Identifier: | NCT00963625 History of Changes |
| Other Study ID Numbers: | SAIRB 07-0014 |
| Study First Received: | August 19, 2009 |
| Last Updated: | October 8, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fertility Center of Las Vegas:
|
Blastocyst transfer endometrial receptivity IVF in vitro fertilization embryo cryopreservation |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 18, 2013