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IVF clinical trials in the Midwest

Reproductive Medicine Associates of New Jersey

ClinicalTrials.gov Identifier:

NCT01866618

Natural IVF study patients will undergo an IVF cycle with trigger shots of Lupron & hCG. Patients will not be given any other stimulating medications during the cycle. They will have 2 uterine aspirations and an endometrial biopsy at designated times. The first uterine aspiration will be randomized to one of four days (day before retrieval, day of retrieval, day after retrieval or 2 days after retrieval). The second uterine aspiration and endometrial biopsy will be performed 6 days after retrieval. Any embryo(s) obtained will be biopsied for Comprehensive Chromosome Screening (CCS) and frozen for use in a subsequent thaw cycle.


Procedure: Uterine Aspiration and Endometrial Biopsy/Embryo Biopsy
Drug: Leuprolide Acetate
Drug: Human Chorionic Gonadotropin (hCG)


Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:

Primary Outcome Measures:
  • Endometrial Changes [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Aneuploidy Rates [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

    To examine aneuploidy rates in embryos from natural IVF cycles.


Other Outcome Measures:
  • Temporal Embryonic Development [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 850
Study Start Date:
Estimated Study Completion Date:
Estimated Primary Completion Date:
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 ovulation

Drug: Human Chorionic Gonadotropin (hCG)

Other Name: hCG 10, 000U given subcutaneously once to induce ovulation


Ages Eligible for Study: 18 Years to 50 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Ovulatory cycles every 39 days or less (natural cycle IVF cannot be performed in someone who does not have cycles)
  • Must be RMANJ patient and have completed all diagnostic screening at one of our RMANJ locations. All diagnostic screening is NOT covered under the study and must be completed prior to being allowed to start the study cycle.
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