Trial · NCT07509840
Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency
NCT07509840, Phase 3, Recruiting, Angelica Lindén Hirschberg
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency. Trials, record NCT07509840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07509840
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency
- NCT number
- NCT07509840
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Angelica Lindén Hirschberg
- Conditions
- Autoimmune Prematur Ovarian Insuffience
- Interventions
- Rituximab (Arm A), Rituximab (Arm B)
- First posted
- 2026-04-03
- Last updated
- 2026-04-03
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Egg retrieval in response to controlled ovarian hyperstimulation | 4 to 6 months after rituximab/placebo treatment. | Egg retrieval (yes/no) in response to controlled ovarian hyperstimulation at 4 to 6 months after rituximab treatment compared to placebo. |
| Secondary | Occurrence of spontaneous menstrual bleeding | 19-month study period from baseline to end of study. | Occurrence of spontaneous menstrual bleeding (yes/no) at any point during the 19-month study period. |
| Secondary | Proportion of participants who achieve ovulation | During 19 months from baseline to end of study. | Proportion of participants who achieve ovulation (defined as serum progesterone \>10 nmol/L) at any time during the study period. |
| Secondary | Changes in serum follicle-stimulating hormone | From baseline to the end of the study period (19 months). | Changes in serum follicle-stimulating hormone (FSH) IE/L levels from baseline to the end of the study period. |
| Secondary | Change in serum anti-Mullerian hormone | From baseline to the end of the study period (19 months). | Changes in serum anti-Mullerian hormone (AMH) microgram/L levels from baseline to the end of the study period. |
| Secondary | Changes in B-cell count | From baseline to the end of the study period (19 month). | Changes in B-cell count x109/L from baseline to end of study. |
| Secondary | Changes in autoantibody indices | From baseline to the end of the study period (19 months) | Changes in autoantibody indices from baseline to the end of the study period. |
| Secondary | Changes in immunoglobulin (IgG) levels | From baseline to the end of the study period (19 months). | Changes in immunoglobulin (IgG) g/L levels from baseline to the end of the study period. |
| Secondary | Changes in quality of life scores, as measured by the Addison's Disease Quality of Life questionnaire | From baseline to the end of the study period (19 months). | Changes in quality of life scores, as measured by the validated instrument Addison's Disease Quality of Life (AddiQol) from baseline to the end of the study period. |
| Secondary | Changes in quality life scores, as measured by the Psychological General Well-being questionnaire | From baseline to the end of the study period (19 months). | Changes in quality life scores, as measured by the validated Psychological General Well-being (PGWB) from baseline to the end of the study period. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07509840
GET https://conductscience.org/api/trials/v1/NCT07509840/registered