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

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

Detailed Description
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Embryo cryopreservation
* Procedure: Fresh blastocyst transfer


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blastocyst transfer in PTEC cycle<br>Transfer of two blastocysts derived from thawed bipronuclear oocytes that were subject to post-thaw extended culture (PTEC). | Procedure: Embryo cryopreservation<br>* Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.<br>|
| Active Comparator: Fresh blastocyst transfer.<br>Transfer of two fresh autologous blastocysts following controlled ovarian stimulation. | Procedure: Fresh blastocyst transfer<br>* Fresh blastocyst transfer following cycle of controlled ovarian stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) |  | 7 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blastocyst transfer, endometrial receptivity, IVF, in vitro fertilization, embryo cryopreservation