Trial · NCT04163458
Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)
NCT04163458, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2023-11-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART). Trials, record NCT04163458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04163458
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)
- NCT number
- NCT04163458
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 405 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Infertility
- Interventions
MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL, MENOPUR powder and solvent for solution for injection, 75 IU, Placebo (for MENOPUR solution for injection in pre-filled pen), Placebo (for MENOPUR powder and solvent for solution for injection)
- First posted
- 2019-11-14
- Last updated
- 2023-11-07
- Results first posted
- 2023-11-07
Source ClinicalTrials.gov
Registered outcomes54
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Fertilized (2 Pronuclei [2PN]) Oocytes | On Day 1 after oocyte retrieval (up to 23 days after start of stimulation) | Fertilized oocytes with 2PN were regarded as correctly fertilized. |
| Secondary | Positive Beta Human Chorionic Gonadotropin (βhCG) Rate | 10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation) | A blood serum βhCG test was obtained 10-14 days after blastocyst transfer. If the test was positive according to the local laboratory's reference ranges, this confirmed a positive βhCG. |
| Secondary | Clinical Pregnancy Rate | 5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation) | Clinical pregnancy was based on detection of at least 1 intrauterine gestational sac with fetal heart beat on transvaginal ultrasound. |
| Secondary | Ongoing Pregnancy Rate | 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation) | Ongoing pregnancy was based on detection of at least 1 intrauterine viable fetus by transvaginal or abdominal ultrasound |
| Secondary | Early Pregnancy Loss | 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation) | Number of participants with early pregnancy loss defined as a positive βhCG tests but no ongoing pregnancy. |
| Secondary | Follicular Development on Stimulation Day 6 | At stimulation Day 6 | The total number of follicles and the number of follicles per size category were reported. |
| Secondary | Follicular Development on Last Day of Stimulation | At last day of stimulation (up to 20 stimulation days) | The total number of follicles and the number of follicles per size category were reported. |
| Secondary | Serum Follicle-stimulating Hormone (FSH) Concentration | At Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation) | The concentration of serum FSH was measured. The median and IQR of FSH levels on stimulation day 6, End of stimulation and Oocyte Retrieval visit are presented. |
| Secondary | Serum Anti-Müllerian Hormone (AMH) Concentration | At the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening) | The concentration of serum AMH was measured. The median and IQR of AMH levels on End of stimulation and End of Trial are presented. |
| Secondary | Human Chorionic Gonadotropin (hCG) Concentration | At Day 6 and last day of stimulation (up to 20 stimulation days) | The concentration of hCG was measured. The median and IQR of hCG levels on stimulation day 6 and End of stimulation are presented. |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 registered outcomesOutcomes54
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Fertilized (2 Pronuclei [2PN]) Oocytes | On Day 1 after oocyte retrieval (up to 23 days after start of stimulation) | Fertilized oocytes | MEAN | |
| SECONDARY | Positive Beta Human Chorionic Gonadotropin (βhCG) Rate | 10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Pregnancy Rate | 5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Ongoing Pregnancy Rate | 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Early Pregnancy Loss | 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation) | Only participants who had a positive βhCG test were eligible. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Follicular Development on Stimulation Day 6 | At stimulation Day 6 | Follicles | MEAN | |
| SECONDARY | Follicular Development on Last Day of Stimulation | At last day of stimulation (up to 20 stimulation days) | Follicles | MEAN | |
| SECONDARY | Serum Follicle-stimulating Hormone (FSH) Concentration | At Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | IU/L | MEDIAN |
| SECONDARY | Serum Anti-Müllerian Hormone (AMH) Concentration | At the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | pmol/L | MEDIAN |
| SECONDARY | Human Chorionic Gonadotropin (hCG) Concentration | At Day 6 and last day of stimulation (up to 20 stimulation days) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | IU/L | MEDIAN |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 outcomesResults by group168
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Fertilized (2 Pronuclei [2PN]) Oocytes | MENOPUR Liquid | 8.3 | Standard Deviation 5.5 | Fertilized oocytes | |
| Number of Fertilized (2 Pronuclei [2PN]) Oocytes | MENOPUR Powder | 6.7 | Standard Deviation 4.2 | Fertilized oocytes | |
| Positive Beta Human Chorionic Gonadotropin (βhCG) Rate | MENOPUR Liquid | 113 | Participants | ||
| Positive Beta Human Chorionic Gonadotropin (βhCG) Rate | MENOPUR Powder | 110 | Participants | ||
| Clinical Pregnancy Rate | MENOPUR Liquid | 94 | Participants | ||
| Clinical Pregnancy Rate | MENOPUR Powder | 88 | Participants | ||
| Ongoing Pregnancy Rate | MENOPUR Liquid | 91 | Participants | ||
| Ongoing Pregnancy Rate | MENOPUR Powder | 85 | Participants | ||
| Early Pregnancy Loss | MENOPUR Liquid | 22 | Participants | ||
| Early Pregnancy Loss | MENOPUR Powder | 25 | Participants |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MENOPUR Liquid | 204 | |
| Overall Study | STARTED | MENOPUR Powder | 201 | |
| Overall Study | mITT | MENOPUR Liquid | 202 | |
| Overall Study | mITT | MENOPUR Powder | 199 | |
| Overall Study | COMPLETED | MENOPUR Liquid | 180 | |
| Overall Study | COMPLETED | MENOPUR Powder | 171 | |
| Overall Study | NOT COMPLETED | MENOPUR Liquid | 24 | |
| Overall Study | NOT COMPLETED | MENOPUR Powder | 30 |
Source ClinicalTrials.gov
Adverse events52
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 | Constipation | Gastrointestinal disorders | MENOPUR Liquid | 6 | 202 | 6 |
| other | Constipation | Gastrointestinal disorders | MENOPUR Powder | 3 | 199 | 3 |
| other | Nausea | Gastrointestinal disorders | MENOPUR Liquid | 3 | 202 | 3 |
| other | Nausea | Gastrointestinal disorders | MENOPUR Powder | 4 | 199 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | MENOPUR Liquid | 3 | 202 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | MENOPUR Powder | 2 | 199 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | MENOPUR Liquid | 3 | 202 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | MENOPUR Powder | 1 | 199 | 1 |
| other | Corona virus infection | Infections and infestations | MENOPUR Liquid | 0 | 202 | 0 |
| other | Corona virus infection | Infections and infestations | MENOPUR Powder | 7 | 199 | 7 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MENOPUR Liquid | 0 | 202 |
| Total, all-cause mortality | MENOPUR Powder | 0 | 199 |
| Total, other adverse events | MENOPUR Liquid | 101 | 202 |
| Total, other adverse events | MENOPUR Powder | 104 | 199 |
| Total, serious adverse events | MENOPUR Liquid | 4 | 202 |
| Total, serious adverse events | MENOPUR Powder | 2 | 199 |
Source ClinicalTrials.gov
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MENOPUR Liquid vs MENOPUR Powder: Ongoing Pregnancy Rate | Trial comparisons |
| MENOPUR Liquid vs MENOPUR Powder: Early Pregnancy Loss | Trial comparisons |
| MENOPUR Liquid vs MENOPUR Powder: Positive Beta Human Chorionic Gonadotropin (βhCG) Rate | Trial comparisons |
| MENOPUR Liquid vs MENOPUR Powder: Number of Participants With Potential Technical Malfunctions of the Administration Pen | Trial comparisons |
| MENOPUR Liquid vs MENOPUR Powder: deaths from any cause | Trial comparisons |
| MENOPUR Liquid vs MENOPUR Powder: Clinical Pregnancy Rate | Trial comparisons |
| MENOPUR Liquid vs MENOPUR Powder: 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/NCT04163458
GET https://conductscience.org/api/trials/v1/NCT04163458/registered?page=2