Natural Cycle In Vitro Fertilization
|ClinicalTrials.gov Identifier: NCT01866618|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment|
|Natural Cycle in Vitro Fertilization (IVF)||Procedure: Uterine Aspiration and Endometrial Biopsy/Embryo Biopsy Drug: Leuprolide Acetate Drug: Human Chorionic Gonadotropin (hCG)|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||524 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Natural Cycle In Vitro Fertilization|
|Study Start Date :||April 2013|
|Primary Completion Date :||August 2016|
|Study Completion Date :||December 2016|
Experimental: Natural IVF Cycle
All patients will undergo a natural IVF cycle using trigger shots of Leuprolide Acetate(Lupron) and human chorionic gonadotropin (hCG) to ensure the patient surges.
Procedure: Uterine Aspiration and Endometrial Biopsy/Embryo Biopsy
Patients will undergo two uterine aspirations and one endometrial biopsy. Any embryos obtained will undergo embryo biopsy for Comprehensive Chromosome Screening (CCS). All embryos will be cryopreserved for subsequent use in a thaw cycle.Drug: Leuprolide Acetate
Other Name: Lupron 40U (2 mgs)given subcutaneously twice at 12 hour intervals to induce ovulationDrug: Human Chorionic Gonadotropin (hCG)
Other Name: hCG 10,000U given subcutaneously once to induce ovulation
- Endometrial Changes [ Time Frame: 1 Year ]To examine the endometrium within the natural cycle in order to accurately characterize the differences in multiple aspects of endocrine and paracrine hormonal activity, the transcriptome of cells influencing oocyte maturation and changes in the endometrium.
- Aneuploidy Rates [ Time Frame: 1 Year ]To examine aneuploidy rates in embryos from natural IVF cycles.
- Temporal Embryonic Development [ Time Frame: 1 Year ]To examine the parameters of temporal embryonic development and the transcriptome of granulosa cells and follicular fluid. The embryos will be graded at standard time points to determine whether there are differences in in vitro development. Granulosa cells and follicular fluid will undergo gene expression analysis and compared to the gene expression profiles found in those specimens in stimulated cycles.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866618
|United States, New Jersey|
|Reproductive Medicine Associates of New Jersey|
|Basking Ridge, New Jersey, United States, 07920|
|Principal Investigator:||Richard T Scott, M.D., HCLD||Reproductive Medicine Associates of New Jersey|