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Natural Cycle In Vitro Fertilization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01866618
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : April 9, 2018
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

Brief Summary:
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.

Condition or disease
Natural Cycle in Vitro Fertilization (IVF)

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Study Type : Observational
Actual Enrollment : 524 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural Cycle In Vitro Fertilization
Study Start Date : April 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : December 2016

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Aneuploidy Rates [ Time Frame: 1 Year ]
    To examine aneuploidy rates in embryos from natural IVF cycles.

Other Outcome Measures:
  1. 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.

Biospecimen Retention:   Samples With DNA
serum samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infertile patients

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.

Exclusion Criteria:

  • Prior enrollment/attempt in this study
  • Requirement for surgical sperm extraction
  • Inability to assess ovaries via transvaginal ultrasound
  • Inability to tolerate vaginal examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01866618

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United States, New Jersey
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
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Principal Investigator: Richard T Scott, M.D., HCLD Reproductive Medicine Associates of New Jersey
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Reproductive Medicine Associates of New Jersey Identifier: NCT01866618    
Other Study ID Numbers: RMA-2013-01
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Keywords provided by Reproductive Medicine Associates of New Jersey:
IVF Cycle