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Natural Cycle In Vitro Fertilization

This study has been completed.
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey Identifier:
First received: May 20, 2013
Last updated: March 16, 2017
Last verified: March 2017
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 Intervention
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
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natural Cycle In Vitro Fertilization

Resource links provided by NLM:

Further study details as provided by Reproductive Medicine Associates of New Jersey:

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

Other Outcome Measures:
  • 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.

Enrollment: 524
Study Start Date: April 2013
Study Completion Date: December 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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   (Adult)
Sexes 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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01866618

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
Principal Investigator: Richard T Scott, M.D., HCLD Reproductive Medicine Associates of New Jersey
  More Information

Additional Information:
Responsible Party: Reproductive Medicine Associates of New Jersey Identifier: NCT01866618     History of Changes
Other Study ID Numbers: RMA-2013-01
Study First Received: May 20, 2013
Last Updated: March 16, 2017

Keywords provided by Reproductive Medicine Associates of New Jersey:
IVF Cycle

Additional relevant MeSH terms:
Chorionic Gonadotropin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on August 22, 2017