Natural Cycle In Vitro Fertilization

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Reproductive Medicine Associates of New Jersey
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT01866618
First received: May 20, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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: 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 ] [ 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: April 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01866618

Contacts
Contact: Monica R Benson, BSN, RN 973-656-2841 clinicalresearchteam@rmanj.com
Contact: Janine M Casciello, BA 973-656-2841 clinicalresearchteam@rmanj.com

Locations
United States, New Jersey
Reproductive Medicine Associates of New Jersey Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Monica R Benson, BSN, RN    973-656-2841    clinicalresearchteam@rmanj.com   
Contact: Janine M Casciello, BA    973-656-2841    clinicalresearchteam@rmanj.com   
Principal Investigator: Richard T Scott, M.D., HCLD         
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Richard T Scott, M.D., HCLD Reproductive Medicine Associates of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01866618     History of Changes
Other Study ID Numbers: RMA-2013-01
Study First Received: May 20, 2013
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Leuprolide
Chorionic Gonadotropin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014