Trial · NCT03738618
Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)
NCT03738618, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2024-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2). Trials, record NCT03738618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03738618
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)
- NCT number
- NCT03738618
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 588 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Infertility, Female
- Interventions
- Follitropin delta, Placebo
- First posted
- 2018-11-13
- Last updated
- 2024-01-18
- Results first posted
- 2024-01-18
Source ClinicalTrials.gov
Registered outcomes69
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of Controlled Ovarian Stimulation (COS) | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | Defined as at least one intrauterine viable fetus 8-9 weeks after transfer. Data in this endpoint are presented for the fresh cycle and the cryopreserved cycles. |
| Secondary | Ongoing Pregnancy Rate in the Fresh Cycle and in the Cryopreserved Cycles | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | Defined as at least one intrauterine viable fetus 8-9 weeks after transfer. Data in this endpoint are presented for the fresh cycle and the cryopreserved cycles. |
| Secondary | Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Including Duration | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | Time from start of COS to ongoing pregnancy, including both the fresh and cryopreserved cycles. In the placebo group, no participants achieved an ongoing pregnancy either after 12 calendar months or after 12 study months. |
| Secondary | Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Measured in Number of Cycles Before Achieving Ongoing Pregnancy | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | Time from start of COS to ongoing pregnancy, including both the fresh and cryopreserved cycles, measured in number of cycles before achieving ongoing pregnancy. In the placebo group, no participants achieved an ongoing pregnancy either after 12 calendar months or after 12 study months. |
| Secondary | Ongoing Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | Defined as the number of intrauterine viable fetuses 8-9 weeks after transfer divided by number of blastocysts transferred. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. One participant can contribute with a range from zero to multiple blastocysts. Data is not shown for placebo arm because no subjects underwent blastocyst transfer in the fresh cycle or cryopreserved cycles. '%' in the unit of measure refers to 'percentage'. |
| Secondary | Clinical Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | Defined at least one gestational sac 5-6 weeks after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. |
| Secondary | Vital Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | Defined at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. |
| Secondary | Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | Defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred. The endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. One participant can contribute with a range from zero to multiple blastocysts. Data is not shown for placebo arm because no subjects underwent blastocyst transfer in the fresh cycle or cryopreserved cycles. '%' in the unit of measure refers to 'percentage'. |
| Secondary | Positive Beta Human Chorionic Gonadotropin (βhCG) Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 10-14 days after transfer (up to approximately 14 months after start of stimulation) | Defined as positive serum βhCG test 10-14 days after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. |
| Secondary | Proportion of Subjects in the Fresh Cycle With Triggering of Final Follicular Maturation (With hCG, With GnRH Agonist, and in Total), Cycle Cancellation and Transfer Cancellation | Up to 5 days after oocyte retrieval (up to 27 days after start of stimulation) | Data in this endpoint are presented for the fresh cycle. |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 registered outcomesOutcomes69
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of Controlled Ovarian Stimulation (COS) | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | percentage of participants | NUMBER |
| SECONDARY | Ongoing Pregnancy Rate in the Fresh Cycle and in the Cryopreserved Cycles | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | percentage of participants | NUMBER |
| SECONDARY | Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Including Duration | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | days | MEAN |
| SECONDARY | Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Measured in Number of Cycles Before Achieving Ongoing Pregnancy | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Cycles | MEAN |
| SECONDARY | Ongoing Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | % of viable fetus/blastocyst transfer | NUMBER |
| SECONDARY | Clinical Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | percentage of participants | NUMBER |
| SECONDARY | Vital Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | percentage of participants | NUMBER |
| SECONDARY | Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | % gestational sacs/blastocyst transfer | NUMBER |
| SECONDARY | Positive Beta Human Chorionic Gonadotropin (βhCG) Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | 10-14 days after transfer (up to approximately 14 months after start of stimulation) | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Subjects in the Fresh Cycle With Triggering of Final Follicular Maturation (With hCG, With GnRH Agonist, and in Total), Cycle Cancellation and Transfer Cancellation | Up to 5 days after oocyte retrieval (up to 27 days after start of stimulation) | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | percentage of participants | NUMBER |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 outcomesResults by group393
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of Controlled Ovarian Stimulation (COS) | FE 999049 (Follitropin Delta) | 43.3 | percentage of participants | ||
| Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of Controlled Ovarian Stimulation (COS) | Placebo | 0.0 | percentage of participants | ||
| Ongoing Pregnancy Rate in the Fresh Cycle and in the Cryopreserved Cycles | FE 999049 (Follitropin Delta) | Fresh cycle | 22.0 | percentage of participants | |
| Ongoing Pregnancy Rate in the Fresh Cycle and in the Cryopreserved Cycles | Placebo | Fresh cycle | 0.0 | percentage of participants | |
| Ongoing Pregnancy Rate in the Fresh Cycle and in the Cryopreserved Cycles | FE 999049 (Follitropin Delta) | Cryopreserved cycles | 47.8 | percentage of participants | |
| Ongoing Pregnancy Rate in the Fresh Cycle and in the Cryopreserved Cycles | Placebo | Cryopreserved cycles | 0 | percentage of participants | |
| Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Including Duration | FE 999049 (Follitropin Delta) | Total number of days until ongoing pregnancy 12 study months | 134.7 | Standard Deviation 87.2 | days |
| Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Including Duration | FE 999049 (Follitropin Delta) | Total number of days until ongoing pregnancy 12 calendar months | 130.1 | Standard Deviation 77.8 | days |
| Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Measured in Number of Cycles Before Achieving Ongoing Pregnancy | FE 999049 (Follitropin Delta) | Number of cycles until ongoing pregnancy 12 study months | 1.8 | Standard Deviation 1.0 | Cycles |
| Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Measured in Number of Cycles Before Achieving Ongoing Pregnancy | FE 999049 (Follitropin Delta) | Number of cycles until ongoing pregnancy 12 calendar months | 1.7 | Standard Deviation 1.0 | Cycles |
1 to 10 of 393Source ClinicalTrials.gov
See all 393 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FE 999049 (Follitropin Delta) | 534 | |
| Overall Study | STARTED | Placebo | 54 | |
| Overall Study | Modified Intention-to-treat (mITT) | FE 999049 (Follitropin Delta) | 533 | |
| Overall Study | Modified Intention-to-treat (mITT) | Placebo | 54 | |
| Overall Study | COMPLETED | FE 999049 (Follitropin Delta) | 502 | |
| Overall Study | COMPLETED | Placebo | 54 | |
| Overall Study | NOT COMPLETED | FE 999049 (Follitropin Delta) | 32 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Procedural pain | Injury, poisoning and procedural complications | FE 999049 (Follitropin Delta) | 111 | 533 | 115 |
| other | Procedural pain | Injury, poisoning and procedural complications | Placebo | 0 | 54 | 0 |
| other | Headache | Nervous system disorders | FE 999049 (Follitropin Delta) | 29 | 533 | 34 |
| other | Headache | Nervous system disorders | Placebo | 2 | 54 | 2 |
| other | Biochemical pregnancy (Fresh cycle) | Pregnancy, puerperium and perinatal conditions | FE 999049 (Follitropin Delta) | 27 | 533 | 27 |
| other | Biochemical pregnancy (Fresh cycle) | Pregnancy, puerperium and perinatal conditions | Placebo | 0 | 54 | 0 |
| other | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | FE 999049 (Follitropin Delta) | 32 | 245 | 35 |
| other | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Placebo | 0 | 54 | 0 |
| other | Biochemical pregnancy (Cryopreserved cycle) | Pregnancy, puerperium and perinatal conditions | FE 999049 (Follitropin Delta) | 29 | 245 | 31 |
| other | Biochemical pregnancy (Cryopreserved cycle) | Pregnancy, puerperium and perinatal conditions | Placebo | 0 | 54 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FE 999049 (Follitropin Delta) | 0 | 533 |
| Total, all-cause mortality | Placebo | 0 | 54 |
| Total, other adverse events | FE 999049 (Follitropin Delta) | 151 | 533 |
| Total, other adverse events | Placebo | 2 | 54 |
| Total, serious adverse events | FE 999049 (Follitropin Delta) | 2 | 533 |
| Total, serious adverse events | Placebo | 0 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40714031 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FE 999049 (Follitropin Delta) vs Placebo: deaths from any cause | Trial comparisons |
| FE 999049 (Follitropin Delta) vs Placebo: serious adverse events | Trial comparisons |
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/NCT03738618
GET https://conductscience.org/api/trials/v1/NCT03738618/registered?page=2