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To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 healthy females undergoing in vitro fertilization (IVF). Each study center will follow its study center standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned prior to the start of stimulation to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified time periods during the cycle for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) tests, and first serum pregnancy test. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menopur/Endometrin | Experimental | Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
|
| Menopur/Progesterone in Oil | Experimental | Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
|
| Follistim/Endometrin | Active Comparator | Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
|
| Follistim/Progesterone in Oil | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menotropin | Drug | 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Ongoing Pregnancy at Week 8 | The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound. | Week 8 (Week 6 of gestation) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Follicles Observed at Day 15 | The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase. | Day 15 |
| Number of Oocytes Retrieved at Day 18 |
Not provided
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 |
|---|---|---|---|---|---|---|
| Huntington Reproductive Center | Pasadena | California | 91105 | United States | ||
| San Diego Fertility Center |
Not provided
One hundred ninety one (191) participants were screened from 6 study centers in the US; 173 of these participants were eligible for randomization. Six subjects did not receive their respected treatment and two subjects withdrew consent, 165 subjects were included in the statistical analyses
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Menopur/Endometrin | Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| FG001 | Menopur/Progesterone in Oil | Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| FG002 | Follistim/Endometrin | Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| FG003 | Follistim/Progesterone in Oil | Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Menopur/Endometrin | Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Follicles Observed at Day 15 | The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase. | Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication | Posted | Mean | Standard Deviation | follicles | Day 15 |
|
Treatment-emergent adverse events were collected from Day 1 to Week 12.
Multiple events in the same system organ class for a subject are only counted once for that system organ class.
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 | Menopur/Endometrin | Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian hyperstimulation syndrome with ascites | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
This was an exploratory study that could be used as the basis for larger, adequately-powered studies. This limitation is the reason no statistical analyses are offered for study outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008596 | Menotropins |
| D011374 | Progesterone |
| C571802 | follitropin beta |
| D009821 | Oils |
| C061018 | ganirelix |
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
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Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
|
|
| Progestrone vaginal insert | Drug | 100 mg progesterone vaginal insert 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test. |
|
|
| follitropin beta | Drug | 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met. |
|
|
| Progesterone in oil | Drug | 50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test. |
|
| Ganirelix | Drug | Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met. |
|
|
The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.
| Approximately Day 18 |
| Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved | The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved. | Approximately Day 19 |
| Number of Embryos Transferred at Three Stages of Development | The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization. | Approximately Day 24 |
| Number of Embryos Frozen at Day 24 | The number of embryos that were not transferred but instead were frozen for future use. | Approximately Day 24 |
| Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle | A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS). | Day 1 to Day 24 |
| Participants With Biochemical Pregnancy at Day 38 | Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer. | approximately day 38 (Day 14 post embryo transfer) |
| Participants With Clinical Pregnancy at Week 7 | Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination. | approximately week 7 |
| Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS) | Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale: mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable. Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly. | Day 1 - week 12 |
| Number of Live Births | Approximately 10 months |
| San Diego |
| California |
| 92130 |
| United States |
| Conceptions Reproductive Associates of Colorado | Littleton | Colorado | 80129 | United States |
| Women's Medical Research Group, LLC | Clearwater | Florida | 33759 | United States |
| The Advanced IVF Institute; Charles E. Miller, MD & Associates | Naperville | Illinois | 60540 | United States |
| A Woman's Center for Reproductive Medicine | Baton Rouge | Louisiana | 70815 | United States |
| Center for Assisted Reproduction | Bedford | Texas | 76022 | United States |
| Inadequate number of oocytes retrieved |
|
| Cycle cancelled |
|
| Risk of ovarian hyperstimulation syndrom |
|
| No positive serum pregnancy |
|
| Pregnancy not confirmed by ultrasound |
|
| Pregnancy loss/miscarriage |
|
| Other |
|
| BG001 | Menopur/Progesterone in Oil | Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| BG002 | Follistim/Endometrin | Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| BG003 | Follistim/Progesterone in Oil | Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Follicle-stimulating hormone level | Mean | Standard Deviation | mIU/mL |
|
| Follistim |
Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil. |
|
|
| Secondary | Number of Oocytes Retrieved at Day 18 | The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration. | Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes retrieved. | Posted | Mean | Standard Deviation | oocytes | Approximately Day 18 |
|
|
|
| Secondary | Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved | The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved. | Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes retrieved. | Posted | Mean | Standard Deviation | proportion of oocytes retrieved | Approximately Day 19 |
|
|
|
| Secondary | Number of Embryos Transferred at Three Stages of Development | The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization. | Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had embryos transferred. | Posted | Mean | Standard Deviation | embryos | Approximately Day 24 |
|
|
|
| Secondary | Number of Embryos Frozen at Day 24 | The number of embryos that were not transferred but instead were frozen for future use. | Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes fertilized | Posted | Mean | Standard Deviation | embryos | Approximately Day 24 |
|
|
|
| Secondary | Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle | A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS). | Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication | Posted | Number | participants | Day 1 to Day 24 |
|
|
|
| Primary | Percentage of Participants With Ongoing Pregnancy at Week 8 | The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound. | Intent to treat population | Posted | Number | percentage of participants | Week 8 (Week 6 of gestation) |
|
|
|
| Secondary | Participants With Biochemical Pregnancy at Day 38 | Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer. | Intent-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had an embryo transfer | Posted | Number | participants | approximately day 38 (Day 14 post embryo transfer) |
|
|
|
| Secondary | Participants With Clinical Pregnancy at Week 7 | Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination. | Intent-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had an embryo transfer | Posted | Number | participants | approximately week 7 |
|
|
|
| Secondary | Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS) | Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale: mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable. Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly. | Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study | Posted | Number | participants | Day 1 - week 12 |
|
|
|
| Secondary | Number of Live Births | Database was locked prior to all participants giving birth. | Posted | Number | live births | Approximately 10 months |
|
|
| 0 |
| 42 |
| 20 |
| 42 |
| EG001 | Menopur/Progesterone in Oil | Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. | 1 | 42 | 18 | 42 |
| EG002 | Follistim/Endometrin | Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. | 1 | 42 | 18 | 42 |
| EG003 | Follistim/Progesterone in Oil | Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. | 0 | 39 | 21 | 39 |
| Hyperemesis gravidarum | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Adnexa uteri pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site discomfort | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Irritability | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Incision site complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site anaesthesia | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bladder pain | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Breast tenderness | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pelvic discomfort | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Uterine spasm | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (Unspecified) | 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.
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D008055 | Lipids |
| Number of Blastocytes transferred |
|
| Mild or moderate adverse event |
|
| Severe adverse event |
|
| Serious adverse event |
|
| Unrelated or unlikely adverse event |
|
| Possibly or probably related adverse event |
|