Natural Cycle In Vitro Fertilization

NCT ID: NCT01866618

Last Updated: 2018-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

524 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Natural Cycle in Vitro Fertilization (IVF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard T Scott, M.D., HCLD

Role: PRINCIPAL_INVESTIGATOR

Reproductive Medicine Associates of New Jersey

Locations

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Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States

Site Status

Countries

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United States

References

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Hong KH, Franasiak JM, Werner MM, Patounakis G, Juneau CR, Forman EJ, Scott RT Jr. Embryonic aneuploidy rates are equivalent in natural cycles and gonadotropin-stimulated cycles. Fertil Steril. 2019 Oct;112(4):670-676. doi: 10.1016/j.fertnstert.2019.05.039.

Reference Type DERIVED
PMID: 31561871 (View on PubMed)

Other Identifiers

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RMA-2013-01

Identifier Type: -

Identifier Source: org_study_id

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