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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001616-30 | EudraCT Number | ||
| U1111-1147-6922 | Other Identifier | WHO |
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This trial investigates the immunogenicity of FE 999049 in repeated cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Follitropin Delta (FE 999049) (COS cycle 2) |
|
| B | Active Comparator | Follitropin Alfa (GONAL-F) (COS cycle 2) |
|
| C | Experimental | Follitropin Delta (FE 999049) (COS cycle 3) |
|
| D | Active Comparator | Follitropin Alfa (GONAL-F) (COS cycle 3) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follitropin Delta (FE 999049) | Drug |
| ||
| Follitropin Alfa (GONAL-F) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles | The proportion (percentage) of participants with at least one treatment-induced anti-FSH antibody response at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by participants in COS cycle 2 are presented. Participants with observations in both cycles are only counted once. | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles | The proportion (percentage) of participants with treatment-induced anti-FSH antibodies with neutralising capacity at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by participants in COS cycle 2 are presented. Participants with observations in both cycles are only counted once. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel (there may be other sites in this country) | Brussels | Belgium | ||||
| Fertilitat and PUC-RS (there may be other sites in this country) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34254211 | Result | Havelock J, Aaris Henningsen AK, Mannaerts B, Arce JC; ESTHER-1 and ESTHER-2 Trial Groups. Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta. J Assist Reprod Genet. 2021 Oct;38(10):2651-2661. doi: 10.1007/s10815-021-02271-5. Epub 2021 Jul 13. | |
| 37156263 |
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Participants who participated in Trial 000004 (NCT01956110) (controlled ovarian stimulation [COS] cycle 1) & failed to achieve ongoing pregnancy were eligible for the trial. For COS cycle 2, 520 participants were screened and 513 enrolled. For COS cycle 3, 190 participants were screened and 189 enrolled. Participants were exposed to the same IMP as in COS cycle 1.
A total of 32 investigational sites included participants to the trial : 3 in Belgium, 3 in Brazil, 3 in Canada, 3 in the Czech Republic, 2 in Denmark, 2 in Italy, 2 in Poland, 2 in Russia, 10 in Spain and 2 in United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | FE 999049 (COS Cycle 2) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| FG001 | GONAL-F (COS Cycle 2) | Follitropin Alfa (GONAL-F) was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 international units (IU) based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| FG002 | FE 999049 (COS Cycle 3) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| FG003 | GONAL-F (COS Cycle 3) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| COS Cycle 2 |
|
| ||||||||||||||||||
| COS Cycle 3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FE 999049 (COS Cycle 2) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Only participants who participated in COS cycle 2 but failed to achieve an ongoing pregnancy could undergo COS cycle 3. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles | The proportion (percentage) of participants with at least one treatment-induced anti-FSH antibody response at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by participants in COS cycle 2 are presented. Participants with observations in both cycles are only counted once. | Safety analysis set (all exposed participants). | Posted | Number | 95% Confidence Interval | Percentage of participants | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose |
|
Adverse events (AEs) were recorded from signed informed consent to the end-of-cycle visit for COS cycle 2 (up to approximately 4.5 months) and again from screening to the end-of-cycle visit for COS cycle 3 (up to approximately 4.5 months).
AEs with onset after start of first administration of IMP and before the end-of-cycle were considered treatment-emergent and are presented for the safety analysis set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FE 999049 (COS Cycle 2) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (17.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
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| ID | Term |
|---|---|
| C000620228 | follitropin delta |
| C000608977 | FE 999049 |
| C571801 | follitropin alfa |
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| Drug |
|
| Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose |
| Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles | The proportion (percentage) of participants with treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity, after one and after two repeated COS cycles is presented. | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose |
| Proportion (Percentage) of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS for Each Controlled Ovarian Stimulation Cycle | The proportion (percentage) of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented. | ≤9 days after triggering of final follicular maturation. |
| Proportion (Percentage) of Subject With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response for Each Controlled Ovarian Stimulation Cycle | Proportion (percentage) of participants with cycle cancellation due to poor ovarian response, excessive ovarian response, and triggering with gonadotropin-releasing hormone (GnRH) agonist are presented. | End-of-stimulation (up to 20 stimulation days) |
| Vital Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle | Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after blastocyst transfer. | 5-6 weeks after blastocyst transfer |
| Implantation Rate for Each Controlled Ovarian Stimulation Cycle | Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred. | 5-6 weeks after blastocyst transfer |
| Ongoing Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle | Ongoing pregnancy rate was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer. | 10-11 weeks after blastocyst transfer |
| Ongoing Implantation Rate for Each Controlled Ovarian Stimulation Cycle | Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred. | 10-11 weeks after blastocyst transfer |
| Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period for Each Controlled Ovarian Stimulation Cycle | Participants self-assessed injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after each injection. The injection site reactions were assessed as none, mild, moderate and severe. The frequency of injection site reactions (mild, moderate or severe) based on all assessment performed is presented. | End-of-stimulation (up to 20 stimulation days) |
| Proportion (Percentage) of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) for Each Controlled Ovarian Stimulation Cycle | Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation. | >9 days after triggering of final follicular maturation |
| Technical Malfunctions of the Administration Pen for Each Controlled Ovarian Stimulation Cycle | Incidences of confirmed technical malfunction of administration pen are presented. | End-of-stimulation (up to 20 stimulation days) |
| Porto Alegre |
| Brazil |
| Pacific Centre for Reproductive Medicine | Burnaby | British Columbia | Canada |
| Olive Fertility Centre | Vancouver | British Columbia | Canada |
| Ottawa Fertility Centre | Ottawa | Ontario | Canada |
| IVF CUBE SE (there may be other sites in this country) | Prague | Czechia |
| Rigshospitalet Fertilitetsklinikken (there may be other sites in this country) | Copenhagen | Denmark |
| Department of Endocrine Gynaecology and Reproductive Medicine, Hôpital Jeanne de Flandre (there may be other sites in this country) | Lille | France |
| Centro Natalità San Raffaele (there may be other sites in this country) | Milan | Italy |
| The nOvum Clinic (there may be other sites in this country) | Warsaw | Poland |
| IVF & Reproductive Genetics Center (there may be other sites in this country) | Moscow | Russia |
| IVI Sevilla (there may be other sites in this country) | Seville | Spain |
| Glasgow Centre for Reproductive Medicine Ltd. (there may be other sites in this country) | Glasgow | United Kingdom |
| Fernandez-Sanchez M, Fatemi H, Garcia-Velasco JA, Heiser PW, Daftary GS, Mannaerts B. Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach. Gynecol Endocrinol. 2023 Dec;39(1):2205952. doi: 10.1080/09513590.2023.2205952. |
| 30801744 | Derived | Nelson SM, Larsson P, Mannaerts BMJL, Nyboe Andersen A, Fauser BCJM. Anti-Mullerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta. Clin Endocrinol (Oxf). 2019 May;90(5):719-726. doi: 10.1111/cen.13956. Epub 2019 Mar 18. |
| Adverse Event |
|
| Personal Reasons |
|
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | GONAL-F (COS Cycle 2) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Only participants who participated in COS cycle 2 but failed to achieve an ongoing pregnancy could undergo COS cycle 3. | Count of Participants | Participants |
|
| OG001 | GONAL-F (COS Cycle 2) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
|
| Secondary | Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles | The proportion (percentage) of participants with treatment-induced anti-FSH antibodies with neutralising capacity at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by participants in COS cycle 2 are presented. Participants with observations in both cycles are only counted once. | Safety analysis set (all exposed participants). | Posted | Number | 95% Confidence Interval | Percentage of participants | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose |
|
|
|
| Secondary | Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles | The proportion (percentage) of participants with treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity, after one and after two repeated COS cycles is presented. | Safety analysis set (all exposed participants). | Posted | Number | 95% Confidence Interval | Percentage of participants | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose |
|
|
|
| Secondary | Proportion (Percentage) of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS for Each Controlled Ovarian Stimulation Cycle | The proportion (percentage) of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented. | Modified intention-to-treat (mITT) analysis set (all exposed participants). This is equivalent to the full analysis set (FAS). | Posted | Number | Percentage of participants | ≤9 days after triggering of final follicular maturation. |
|
|
|
| Secondary | Proportion (Percentage) of Subject With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response for Each Controlled Ovarian Stimulation Cycle | Proportion (percentage) of participants with cycle cancellation due to poor ovarian response, excessive ovarian response, and triggering with gonadotropin-releasing hormone (GnRH) agonist are presented. | mITT analysis set (all exposed participants). This is equivalent to the FAS. | Posted | Number | Percentage of participants | End-of-stimulation (up to 20 stimulation days) |
|
|
|
| Secondary | Vital Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle | Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after blastocyst transfer. | mITT analysis set (all exposed participants). This is equivalent to the FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | 5-6 weeks after blastocyst transfer |
|
|
|
| Secondary | Implantation Rate for Each Controlled Ovarian Stimulation Cycle | Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred. | Participants with blastocyst transfer. In COS cycle 2, a total of 254 and 271 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. In COS cycle 3, a total of 132 and 121 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. | Posted | Number | 95% Confidence Interval | Percentage | 5-6 weeks after blastocyst transfer |
|
|
|
| Secondary | Ongoing Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle | Ongoing pregnancy rate was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer. | mITT analysis set (all exposed participants). This is equivalent to FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | 10-11 weeks after blastocyst transfer |
|
|
|
| Secondary | Ongoing Implantation Rate for Each Controlled Ovarian Stimulation Cycle | Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred. | Participants with blastocyst transfer. In COS cycle 2, a total of 254 and 271 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. In COS cycle 3, a total of 132 and 121 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. | Posted | Number | 95% Confidence Interval | Percentage | 10-11 weeks after blastocyst transfer |
|
|
|
| Secondary | Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period for Each Controlled Ovarian Stimulation Cycle | Participants self-assessed injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after each injection. The injection site reactions were assessed as none, mild, moderate and severe. The frequency of injection site reactions (mild, moderate or severe) based on all assessment performed is presented. | Safety analysis set (all exposed participants). | Posted | Number | Percentage of events | End-of-stimulation (up to 20 stimulation days) |
|
|
|
| Secondary | Proportion (Percentage) of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) for Each Controlled Ovarian Stimulation Cycle | Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation. | Safety analysis set (all exposed participants). | Posted | Number | Percentage of participants | >9 days after triggering of final follicular maturation |
|
|
|
| Secondary | Technical Malfunctions of the Administration Pen for Each Controlled Ovarian Stimulation Cycle | Incidences of confirmed technical malfunction of administration pen are presented. | Safety analysis set (all exposed participants). | Posted | Number | Percentage of participants | End-of-stimulation (up to 20 stimulation days) |
|
|
|
| 0 |
| 252 |
| 4 |
| 252 |
| 70 |
| 252 |
| EG001 | GONAL-F (COS Cycle 2) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | 0 | 261 | 4 | 261 | 77 | 261 |
| EG002 | FE 999049 (COS Cycle 3) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | 0 | 95 | 0 | 95 | 26 | 95 |
| EG003 | GONAL-F (COS Cycle 3) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | 0 | 93 | 1 | 93 | 34 | 93 |
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (17.1) | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (17.1) | Systematic Assessment |
|
| Vomiting in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (17.1) | Systematic Assessment |
|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Biochemical pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (17.1) | Systematic Assessment |
|
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (17.1) | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (17.1) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pelvic discomfort | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Antibodies with neutralising capacity |
|
| Early OHSS (moderate/severe) |
|
| Any preventive intervention |
|
| Early OHSS (any grade) / preventive |
|
| Early OHSS (moderate/severe) / preventive |
|
| Cycle cancelled due to excessive ovarian response |
|
| Triggering with GnRH agonist |
|
| Late OHSS (moderate/severe) |
|