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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000154-61 | EudraCT Number |
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We want to find out if kisspeptin is successful in stimulating oocyte maturation when it is used as a 'trigger' injection during IVF therapy for infertility.
Participants in the study will have a standard Gonadotrophin Releasing Hormone (GnRH) antagonist IVF cycle, but instead of having a trigger injection of hCG (human chorionic gonadotrophin) they will be randomised to receive one of 4 doses of kisspeptin injection.
Oocytes will be retrieved and graded by an embryologist to see whether or not they have matured.
The reproductive hormones Luteinising hormone, follicle stimulating hormone, oestradiol and progesterone will also be measured
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kisspeptin-54, 1.6 single | Experimental | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 1.6 nmol/kg |
|
| Kisspeptin-54, 3.2 single | Experimental | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg |
|
| Kisspeptin-54, 6.4 single | Experimental | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg |
|
| Kisspeptin-54, 12.8 single | Experimental | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg |
|
| Kisspeptin-54 OHSS, 3.2 single | Experimental | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kisspeptin 1.6nmol/kg | Drug | single kisspeptin dose 1.6 nmol/kg subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Oocyte Maturation | This was assessed by oocyte yield (percentage of mature [metaphase 2; M2] oocytes collected from the number of follicles ≥ 14 mm on final ultrasound scan prior to kisspeptin-54 trigger administration | 36 hours post Kisspeptin-54 trigger injection |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Pregnancy | Number of participants achieving biochemical pregnancy by serum βhCG > 10 mIU/mL | 11 days after embryo transfer |
| Occurrence of OHSS | Women were routinely screened for the development of early OHSS and late OHSS. Women were screened by symptoms, blood analysis, and ultrasound parameters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer
woman undergoing IVF treatment
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| Name | Affiliation | Role |
|---|---|---|
| Waljit S Dhillo, PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Hospital | London | W12 0NN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25036713 | Result | Jayasena CN, Abbara A, Comninos AN, Nijher GM, Christopoulos G, Narayanaswamy S, Izzi-Engbeaya C, Sridharan M, Mason AJ, Warwick J, Ashby D, Ghatei MA, Bloom SR, Carby A, Trew GH, Dhillo WS. Kisspeptin-54 triggers egg maturation in women undergoing in vitro fertilization. J Clin Invest. 2014 Aug;124(8):3667-77. doi: 10.1172/JCI75730. Epub 2014 Jul 18. | |
| 28854728 |
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Data will be presented in anonymised groups
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Parallel study, volunteers received only one type of dose
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| ID | Title | Description |
|---|---|---|
| FG000 | Kisspeptin-54 1.6 Single | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 1.6 nmol/kg |
| FG001 | Kispeptin-54 3.2 Single |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2015 | Aug 5, 2019 |
Not provided
Different dose for each volunteer
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Not provided
participants and IVF physicians were blinded.
|
| Kisspeptin-54 OHSS, 6.4 single | Experimental | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg |
|
| Kisspeptin-54 OHSS, 9.6 single | Experimental | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg |
|
| Kisspeptin-54 OHSS, 12.8 single | Experimental | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg |
|
| Kisspeptin-54 OHSS, 9.6 + 9.6 | Experimental | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later |
|
| Kisspeptin-54 OHSS, 9.6 + saline | Experimental | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later |
|
| Kisspeptin 3.2nmol/kg | Drug | single kisspeptin dose 3.2 nmol/kg subcutaneously |
|
|
| Kisspeptin 6.4nmol/kg | Drug | single kisspeptin dose 6.4 nmol/kg subcutaneously |
|
|
| Kisspeptin 9.6nmol/kg | Drug | single kisspeptin dose 9.6 nmol/kg subcutaneously |
|
|
| Kisspeptin 12.8nmol/kg | Drug | single kisspeptin dose 12.8 nmol/kg subcutaneously |
|
|
| Kisspeptin 9.6 nmol/kg double | Drug | kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously |
|
|
| Kisspeptin 9.6 nmol/kg + saline | Drug | kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart |
|
|
| 11 days following embryo transfer |
| Fertilization Rate | Percentage of M2 oocytes that fertilize to form two pronuclear [2PN] zygotes following intracytoplasmic injection with sperm [ICSI] | 3 days after oocyte retrieval |
| Embryo Formation | All embryos were graded at day 3 by an independent embryologist, blinded to doses of kisspeptin administered, using the British Fertility Society and Association of Clinical Embryologist embryo grading scheme for cleavage stage embryos, which describes embryos based on cell number, blastomere size, and fragmentation | 3 days after oocyte retrieval |
| Number of Participants With Clinical Pregnancy | Intrauterine gestational sac with heartbeat on ultrasound at 6 weeks' gestation | 6 weeks after embryo transfer |
| Abbara A, Clarke S, Islam R, Prague JK, Comninos AN, Narayanaswamy S, Papadopoulou D, Roberts R, Izzi-Engbeaya C, Ratnasabapathy R, Nesbitt A, Vimalesvaran S, Salim R, Lavery SA, Bloom SR, Huson L, Trew GH, Dhillo WS. A second dose of kisspeptin-54 improves oocyte maturation in women at high risk of ovarian hyperstimulation syndrome: a Phase 2 randomized controlled trial. Hum Reprod. 2017 Sep 1;32(9):1915-1924. doi: 10.1093/humrep/dex253. |
| 26192876 | Result | Abbara A, Jayasena CN, Christopoulos G, Narayanaswamy S, Izzi-Engbeaya C, Nijher GM, Comninos AN, Peters D, Buckley A, Ratnasabapathy R, Prague JK, Salim R, Lavery SA, Bloom SR, Szigeti M, Ashby DA, Trew GH, Dhillo WS. Efficacy of Kisspeptin-54 to Trigger Oocyte Maturation in Women at High Risk of Ovarian Hyperstimulation Syndrome (OHSS) During In Vitro Fertilization (IVF) Therapy. J Clin Endocrinol Metab. 2015 Sep;100(9):3322-31. doi: 10.1210/jc.2015-2332. Epub 2015 Jul 20. |
| 29446481 | Derived | Abbara A, Islam R, Clarke SA, Jeffers L, Christopoulos G, Comninos AN, Salim R, Lavery SA, Vuong TNL, Humaidan P, Kelsey TW, Trew GH, Dhillo WS. Clinical parameters of ovarian hyperstimulation syndrome following different hormonal triggers of oocyte maturation in IVF treatment. Clin Endocrinol (Oxf). 2018 Jun;88(6):920-927. doi: 10.1111/cen.13569. Epub 2018 Mar 6. |
| 29206944 | Derived | Owens LA, Abbara A, Lerner A, O'floinn S, Christopoulos G, Khanjani S, Islam R, Hardy K, Hanyaloglu AC, Lavery SA, Dhillo WS, Franks S. The direct and indirect effects of kisspeptin-54 on granulosa lutein cell function. Hum Reprod. 2018 Feb 1;33(2):292-302. doi: 10.1093/humrep/dex357. |
Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg
| FG002 | Kisspeptin-54 6.4 Single | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg |
| FG003 | Kisspeptin-54 12.8 Single | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg |
| FG004 | OHSS - Kisspeptin-54 3.2 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg |
| FG005 | OHSS - Kisspeptin-54 6.4 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg |
| FG006 | OHSS - Kisspeptin-54 9.6 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg |
| FG007 | OHSS - Kisspeptin-54 12.8 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg |
| FG008 | Kisspeptin-54 9.6 + 9.6 | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later |
| FG009 | Kisspeptin-54 9.6 + Saline | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Kisspeptin-54 1.6 Single | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 1.6 nmol/kg |
| BG001 | Kispeptin-54 3.2 Single | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg |
| BG002 | Kisspeptin-54 6.4 Single | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg |
| BG003 | Kisspeptin-54 12.8 Single | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg |
| BG004 | OHSS - Kisspeptin-54 3.2 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg |
| BG005 | OHSS - Kisspeptin-54 6.4 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg |
| BG006 | OHSS - Kisspeptin-54 9.6 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg |
| BG007 | OHSS - Kisspeptin-54 12.8 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg |
| BG008 | Kisspeptin-54 9.6 + 9.6 | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later |
| BG009 | Kisspeptin-54 9.6 + Saline | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Inter-Quartile Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| BMI 18-29 | Mean | Standard Deviation | kg/m^2 |
| ||||||||||
| Anti-mullerian hormone (AMH) | Median | Standard Deviation | pmol/L |
| ||||||||||
| Antral Follicle Count (AFC) | Median | Standard Deviation | Follicles |
|
| 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 | Percentage of Oocyte Maturation | This was assessed by oocyte yield (percentage of mature [metaphase 2; M2] oocytes collected from the number of follicles ≥ 14 mm on final ultrasound scan prior to kisspeptin-54 trigger administration | Posted | Mean | Standard Deviation | percentage of expected oocyte yield | 36 hours post Kisspeptin-54 trigger injection |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Biochemical Pregnancy | Number of participants achieving biochemical pregnancy by serum βhCG > 10 mIU/mL | All participants | Posted | Count of Participants | Participants | 11 days after embryo transfer |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of OHSS | Women were routinely screened for the development of early OHSS and late OHSS. Women were screened by symptoms, blood analysis, and ultrasound parameters | Occurence of OHSS was not analysed in the groups where number of participants analysed is zero as this first phase was to test only the hypothesis that kisspeptin-54 could be used to trigger egg maturation in women undergoing in vitro fertilization therapy. | Posted | Count of Participants | Participants | 11 days following embryo transfer |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fertilization Rate | Percentage of M2 oocytes that fertilize to form two pronuclear [2PN] zygotes following intracytoplasmic injection with sperm [ICSI] | All participants | Posted | Mean | Standard Deviation | percentage of 2PN zygotes | 3 days after oocyte retrieval |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Embryo Formation | All embryos were graded at day 3 by an independent embryologist, blinded to doses of kisspeptin administered, using the British Fertility Society and Association of Clinical Embryologist embryo grading scheme for cleavage stage embryos, which describes embryos based on cell number, blastomere size, and fragmentation | All participants | Posted | Mean | Standard Deviation | formed embryos | 3 days after oocyte retrieval |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Pregnancy | Intrauterine gestational sac with heartbeat on ultrasound at 6 weeks' gestation | All participants | Posted | Count of Participants | Participants | 6 weeks after embryo transfer |
|
4 years
Not provided
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 | KP-54 1.6nmol/kg Single | Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 1.6nmol/kg as a trigger injection. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | KP-54 3.2nmol/kg Single | Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | KP-54 6.4nmol/kg Single | Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection. | 0 | 24 | 1 | 24 | 0 | 24 |
| EG003 | KP-54 12.8nmol/kg Single | Participants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection. | 0 | 24 | 2 | 24 | 0 | 24 |
| EG004 | KP-54 OHSS 3.2nmol/kg Single | Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG005 | KP-54 OHSS 6.4nmol/kg Single | Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection. | 0 | 20 | 1 | 20 | 0 | 20 |
| EG006 | KP-54 OHSS 9.6nmol/kg Single | Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 9.6nmol/kg as a trigger injection. | 0 | 15 | 2 | 15 | 0 | 15 |
| EG007 | KP-54 OHSS 12.8nmol/kg Single | Participants with a high risk of ovarian hyper-stimulation syndrome (OHSS), undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection. | 0 | 20 | 2 | 20 | 0 | 20 |
| EG008 | KP-54 OHSS 9.6 + 9.6 Nmol/kg | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later | 0 | 31 | 0 | 31 | 0 | 31 |
| EG009 | KP-54 OHSS 9.6nmol/kg + Saline | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later | 0 | 31 | 1 | 31 | 0 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Heterotopic pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Still birth | Reproductive system and breast disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Waljit Dhillo | Imperial College London | 442083833242 | w.dhillo@imperial.ac.uk |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2015 | Aug 5, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059648 | Kisspeptins |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009479 | Neuropeptides |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
|
|
|
|
|
|
|
Phase 2 |
| Fisher Exact |
| <0.05 |
| Other |
| Phase 3 | Regression, Logistic | <0.05 | Odds Ratio (OR) | 0.05 | 1-Sided | 95 | Estimate of difference in success rates and estimate of odds ratio for success were derived, with P value comparing 2 treatment groups, 95% confidence intervals. | Other |
| OG004 |
| KP-54 OHSS 3.2nmol/kg Single |
Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 3.2nmol/kg had blood level of luteinising hormone (LH) measured at T=0 |
| OG005 | KP-54 OHSS 6.4nmol/kg Single | Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 6.4nmol/kg had blood level of luteinising hormone (LH) measured at T=0 |
| OG006 | KP-54 OHSS 9.6nmol/kg | Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 9.6nmol/kg had blood level of luteinising hormone (LH) measured at T=0 |
| OG007 | KP-54 OHSS 12.8nmol/kg Single | Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 12.8nmol/kg had blood level of luteinising hormone (LH) measured at T=0 |
| OG008 | KP-54 OHSS 9.6 +9.6 Nmol/kg | Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 9.6nmol/kg followed by another injection of KP-54 9.6nmol/kg 10 hours later, had blood level of luteinising hormone (LH) measured at T=0 |
| OG009 | KP-54 OHSS 9.6 + Saline | Participants, at high risk of ovarian hyper-stimulation syndrome, undergoing IV treatment with trigger dose 9.6nmol/kg followed by another injection of saline10 hours later, had blood level of luteinising hormone (LH) measured at T=0 |
|
|
|
| OG003 | Kisspeptin-54, 12.8 Single | Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg Kisspeptin 12.8nmol/kg: single kisspeptin dose 12.8 nmol/kg subcutaneously |
| OG004 | Kisspeptin-54 OHSS, 3.2 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg Kisspeptin 3.2nmol/kg: single kisspeptin dose 3.2 nmol/kg subcutaneously |
| OG005 | Kisspeptin-54 OHSS, 6.4 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg Kisspeptin 6.4nmol/kg: single kisspeptin dose 6.4 nmol/kg subcutaneously |
| OG006 | Kisspeptin-54 OHSS, 9.6 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg Kisspeptin 9.6nmol/kg: single kisspeptin dose 9.6 nmol/kg subcutaneously |
| OG007 | Kisspeptin-54 OHSS, 12.8 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg Kisspeptin 12.8nmol/kg: single kisspeptin dose 12.8 nmol/kg subcutaneously |
| OG008 | Kisspeptin-54 OHSS, 9.6 + 9.6 | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later Kisspeptin 9.6 nmol/kg double: kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously |
| OG009 | Kisspeptin-54 OHSS, 9.6 + Saline | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later Kisspeptin 9.6 nmol/kg + saline: kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart |
|
|
| OG004 | OHSS - Kisspeptin-54 3.2 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg |
| OG005 | OHSS - Kisspeptin-54 6.4 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg |
| OG006 | OHSS - Kisspeptin-54 9.6 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg |
| OG007 | OHSS - Kisspeptin-54 12.8 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg |
| OG008 | Kisspeptin-54 9.6 + 9.6 | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later |
| OG009 | Kisspeptin-54 9.6 + Saline | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later |
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Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg |
| OG004 | OHSS - Kisspeptin-54 3.2 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg |
| OG005 | OHSS - Kisspeptin-54 6.4 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg |
| OG006 | OHSS - Kisspeptin-54 9.6 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg |
| OG007 | OHSS - Kisspeptin-54 12.8 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg |
| OG008 | Kisspeptin-54 9.6 + 9.6 | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later |
| OG009 | Kisspeptin-54 9.6 + Saline | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later |
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| OG004 | OHSS - Kisspeptin-54 3.2 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg |
| OG005 | OHSS - Kisspeptin-54 6.4 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg |
| OG006 | OHSS - Kisspeptin-54 9.6 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg |
| OG007 | OHSS - Kisspeptin-54 12.8 Single | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg |
| OG008 | Kisspeptin-54 9.6 + 9.6 | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later |
| OG009 | Kisspeptin-54 9.6 + Saline | Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later |
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