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OpenTrials
Completed

NCT Number: NCT01866618

Natural Cycle In Vitro Fertilization

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.

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Key information

Conditions

Natural Cycle in Vitro Fertilization (IVF)

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Aneuploidy Rates

    Time frame: 1 Year

    To examine aneuploidy rates in embryos from natural IVF cycles.

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 31, 2013
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.