Natural Cycle in Vitro Fertilization (IVF)NCT01866618
Natural Cycle In Vitro Fertilization
An observational study of Natural Cycle in Vitro Fertilization (IVF), run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Natural Cycle in Vitro Fertilization (IVF)
- How many people
- 524 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile patients
Who may be able to join
- 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.
Who cannot join
- Prior enrollment/attempt in this study
- Requirement for surgical sperm extraction
- Inability to assess ovaries via transvaginal ultrasound
- Inability to tolerate vaginal examination
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
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.
- Keywords
- Natural, IVF Cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Changes
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.
Measured: 1 Year
Secondary outcomes (1)
Aneuploidy Rates
To examine aneuploidy rates in embryos from natural IVF cycles.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Natural Cycle in Vitro Fertilization (IVF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T Scott, M.D., HCLD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866618
- Sponsor's protocol ID
- RMA-2013-01
- Status last verified
- Apr 2018
- First submitted
- 20 May 2013
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31561871
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Cycle In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01866618
- Acronym / sponsor ID
- RMA-2013-01
- Keywords
- Natural, IVF Cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Prior enrollment/attempt in this study
- Requirement for surgical sperm extraction
- Inability to assess ovaries via transvaginal ultrasound
- Inability to tolerate vaginal examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Aneuploidy Rates
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Derived from this study: PubMed 31561871Hong 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T Scott, M.D., HCLD principal investigator
Reproductive Medicine Associates of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Natural Cycle in Vitro Fertilization (IVF), run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Changes (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01866618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018; AzTrials last refreshed its copy on 30 Oct 2026.