Infertility (IVF Patients)NIRONCT07134920
Norethindrone Impact on Receptiva Outcomes
An observational study of Infertility (IVF Patients) and Infertility Female, run by Inception Fertility Research Institute, LLC at 1 site in United States.
Trial summary
This retrospective study aims to evaluate pregnancy outcomes in patients with a positive BCL6 test (ReceptivaDx, who were treated with either norethindrone acetate or Depo Lupron prior to embryo transfer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility (IVF Patients), Infertility Female
- Type of treatment
- Injection or infusion
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 19 Dec 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with a ReceptivaDx BCL6-positive test who completed hormonal suppression therapy prior to embryo transfer cycle
Who may be able to join
- Diagnosis of recurrent pregnancy loss, recurrent implantation failure, unexplained infertility or severe dysmenorrhea and a positive BCL6 test Receptivadx
- Underwent assisted reproductive technology (ART or IVF)
- Treated with norethinedrone acetate 5 mg daily for 6 and 8 weeks or two monthly injections of Depo Leuprolide Acetate 7.5mg rior to embryo transfer cycle
- Euploid embryo transfer cycle was initiated within 1 week of completion of suppression protocol
- Adequate clinical documentation available, including treatment protocol, BCL6 results, and pregnancy outcomes
- If Endometrial Receptivity Analysis (ERA) was performed, result must be "receptive"
- A minimum uterine lining of 7.5mm was documented by ultrasound prior to the initiation of progesterone
Who cannot join
- Use of both norethinedrone acetate and Depo Leuprolide Acetate in the same treatment cycle
- Incomplete ART or outcome data
- Gestational carrier or egg donor
- No prescribed adjuvant therapy (e.g., Lovenox, Neupogen, IVIG)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BCL6 Positivity and ART Outcomes: Comparing Norethindrone Acetate and Depo Lupron for Endometriosis Suppression Prior to Embryo Transfer
This retrospective study aims to evaluate pregnancy outcomes in patients with a positive BCL6 test (ReceptivaDx, who were treated with either norethindrone acetate or Depo Lupron prior to embryo transfer. The current standard of care involves treatment with Depo Lupron, a GnRH agonist associated with significant hypoestrogenic side effects that mimic menopausal symptoms. Additionally, Depo Lupron is costly, with a retail price exceeding $2,000 per dose. In contrast, norethindrone acetate is a well-tolerated oral progestin, available at a fraction of the cost (under $100 for a one-month course). While prior studies have demonstrated comparable efficacy between Depo Lupron and norethindrone for managing endometriosis-associated pain, their relative effectiveness in improving reproductive outcomes-particularly in BCL6-positive patients undergoing embryo transfer-remains underexplored. This study seeks to address that gap by comparing ongoing pregnancy, live birth, and miscarriage rates between the two treatment groups.
Hypothesis: IVF Patients testing positive for BCL6 and treated with norethindrone will not do worse than the current recommended treatment of 60 days Depo leuprolide as defined by two endpoint metrics, pregnancy rate and live birth rate.
- Conditions
- Infertility (IVF Patients), Infertility Female
- Keywords
- Receptiva, Depo Lupron Acetate, Norethindrone Acetate
- Medical subject headings
- Infertility, Infertility, Female
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 |
|---|---|---|
| Norethindrone acetate Group | Patients who received 6 and 8 weeks of suppression with norethindrone acetate prior to embryo transfer cycle | |
| Depo Leuprolide Group | Patients who received two monthly injections of Depo Leuprolide Acetate prior to embryo transfer cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
To compare ongoing pregnancy rates in BCL6-positive patients treated with norethindrone acetate versus Depo Lupron acetate
Measured: From beginning of treatment to 12 weeks post embryo transfer
Secondary outcomes (4)
Live birth rate
To compare live birth rates in BCL6-positive patients treated with norethindrone acetate versus Depo Lupron acetate
Measured: From start of treatment to 10 months post embryo transfer
Miscarriage Rate
Defined as the loss of a clinically confirmed pregnancy before 20 weeks of gestation
Measured: From start of treatment to 20 weeks post embryo transfer
Biochemical pregnancy rate
Defined as a low positive serum HCG with an inappropriate rise, spontaneous resolution
Measured: From start of treatment to 4 weeks post embryo transfer
Ectopic pregnancy rate
Measured: From start of treatment to 8 weeks post embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start12 Aug 2025
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)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
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inception Fertility Research Institute, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cicero Diagnostic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134920
- Sponsor's protocol ID
- IRI-MLF-2025-002
- Acronym
- NIRO
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BCL6 Positivity and ART Outcomes: Comparing Norethindrone Acetate and Depo Lupron for Endometriosis Suppression Prior to Embryo Transfer
- ClinicalTrials.gov ID
- NCT07134920
- Acronym / sponsor ID
- NIRO / IRI-MLF-2025-002
- Conditions
- Infertility (IVF Patients), Infertility Female
- Keywords
- Receptiva, Depo Lupron Acetate, Norethindrone Acetate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Inception Fertility Research Institute, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Cicero Diagnostic
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 21 Aug 2025 (actual)
- 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.
This retrospective study aims to evaluate pregnancy outcomes in patients with a positive BCL6 test (ReceptivaDx, who were treated with either norethindrone acetate or Depo Lupron prior to embryo transfer. The current standard of care involves treatment with Depo Lupron, a GnRH agonist associated with significant hypoestrogenic side effects that mimic menopausal symptoms. Additionally, Depo Lupron is costly, with a retail price exceeding $2,000 per dose. In contrast, norethindrone acetate is a well-tolerated oral progestin, available at a fraction of the cost (under $100 for a one-month course). While prior studies have demonstrated comparable efficacy between Depo Lupron and norethindrone for managing endometriosis-associated pain, their relative effectiveness in improving reproductive outcomes-particularly in BCL6-positive patients undergoing embryo transfer-remains underexplored. This study seeks to address that gap by comparing ongoing pregnancy, live birth, and miscarriage rates between the two treatment groups.
Hypothesis: IVF Patients testing positive for BCL6 and treated with norethindrone will not do worse than the current recommended treatment of 60 days Depo leuprolide as defined by two endpoint metrics, pregnancy rate and live birth rate.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norethindrone acetate Group | – | –Patients who received 6 and 8 weeks of suppression with norethindrone acetate prior to embryo transfer cycle |
| Depo Leuprolide Group | – | –Patients who received two monthly injections of Depo Leuprolide Acetate prior to embryo transfer cycle |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with a ReceptivaDx BCL6-positive test who completed hormonal suppression therapy prior to embryo transfer cycle
Key inclusion criteria (7 listed)
- Diagnosis of recurrent pregnancy loss, recurrent implantation failure, unexplained infertility or severe dysmenorrhea and a positive BCL6 test Receptivadx
- Underwent assisted reproductive technology (ART or IVF)
- Treated with norethinedrone acetate 5 mg daily for 6 and 8 weeks or two monthly injections of Depo Leuprolide Acetate 7.5mg rior to embryo transfer cycle
- Euploid embryo transfer cycle was initiated within 1 week of completion of suppression protocol
- Adequate clinical documentation available, including treatment protocol, BCL6 results, and pregnancy outcomes
Key exclusion criteria (4 listed)
- Use of both norethinedrone acetate and Depo Leuprolide Acetate in the same treatment cycle
- Incomplete ART or outcome data
- Gestational carrier or egg donor
- No prescribed adjuvant therapy (e.g., Lovenox, Neupogen, IVIG)
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
Ongoing pregnancy rate
Time frame: From beginning of treatment to 12 weeks post embryo transfer
To compare ongoing pregnancy rates in BCL6-positive patients treated with norethindrone acetate versus Depo Lupron acetate
4 secondary outcomes
Live birth rate
Time frame: From start of treatment to 10 months post embryo transfer
Miscarriage Rate
Time frame: From start of treatment to 20 weeks post embryo transfer
Biochemical pregnancy rate
Time frame: From start of treatment to 4 weeks post embryo transfer
Ectopic pregnancy rate
Time frame: From start of treatment to 8 weeks post embryo transfer
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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infertility (IVF Patients) and Infertility Female, run by Inception Fertility Research Institute, LLC 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 7 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 15 Apr 2026. 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?
Ongoing pregnancy rate (time frame: From beginning of treatment to 12 weeks post embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.