Overview

This trial is active, not recruiting.

Condition natural cycle in vitro fertilization (ivf)
Treatments uterine aspiration and endometrial biopsy/embryo biopsy, leuprolide acetate, human chorionic gonadotropin (hcg)
Sponsor Reproductive Medicine Associates of New Jersey
Start date April 2013
End date September 2016
Trial size 850 participants
Trial identifier NCT01866618, RMA-2013-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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.
leuprolide acetate Lupron 40U (2 mgs)given subcutaneously twice at 12 hour intervals to induce ovulation
human chorionic gonadotropin (hcg) hCG 10,000U given subcutaneously once to induce ovulation

Primary Outcomes

Measure
Endometrial Changes
time frame: 1 Year

Secondary Outcomes

Measure
Aneuploidy Rates
time frame: 1 Year

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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

Additional Information

Official title Natural Cycle In Vitro Fertilization
Principal investigator Richard T Scott, M.D., HCLD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Reproductive Medicine Associates of New Jersey.