- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01667406
The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
Study Overview
Status
Conditions
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, W12 0NN
- Hammersmith Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18 - 34 years
- Body mass index between 18 and 29 kg/m2
- Stable body weight for at least 3 months
- Normal early menstrual cycle follicular phase serum FSH concentration
- Serum anti-Mullerian hormone (AMH) > 40pmol/L
- No more than one previous IVF treatment cycle
- Both ovaries intact
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
- Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study
- Treatment with an investigational drug within the preceding 2 months
- Donated blood during the preceding 3 months or intention to do so before the end of the study
- Previous poor response to IVF treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
single kisspeptin dose 1.6 nmol/kg subcutaneously
Other Names:
|
Experimental: Kisspeptin-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
|
single kisspeptin dose 3.2 nmol/kg subcutaneously
Other Names:
|
Experimental: 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
|
single kisspeptin dose 6.4 nmol/kg subcutaneously
Other Names:
|
Experimental: 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
|
single kisspeptin dose 12.8 nmol/kg subcutaneously
Other Names:
|
Experimental: 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
|
single kisspeptin dose 3.2 nmol/kg subcutaneously
Other Names:
|
Experimental: 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
|
single kisspeptin dose 6.4 nmol/kg subcutaneously
Other Names:
|
Experimental: 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
|
single kisspeptin dose 9.6 nmol/kg subcutaneously
Other Names:
|
Experimental: 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
|
single kisspeptin dose 12.8 nmol/kg subcutaneously
Other Names:
|
Experimental: 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 dose 9.6 nmol/kg given twice 10hrs apart subcutaneously
Other Names:
|
Experimental: 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 dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Oocyte Maturation
Time Frame: 36 hours post Kisspeptin-54 trigger injection
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical Pregnancy
Time Frame: 11 days after embryo transfer
|
Number of participants achieving biochemical pregnancy by serum βhCG > 10 mIU/mL
|
11 days after embryo transfer
|
Occurrence of OHSS
Time Frame: 11 days following embryo transfer
|
Women were routinely screened for the development of early OHSS and late OHSS.
Women were screened by symptoms, blood analysis, and ultrasound parameters
|
11 days following embryo transfer
|
Fertilization Rate
Time Frame: 3 days after oocyte retrieval
|
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
Time Frame: 3 days after oocyte retrieval
|
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
Time Frame: 6 weeks after embryo transfer
|
Intrauterine gestational sac with heartbeat on ultrasound at 6 weeks' gestation
|
6 weeks after embryo transfer
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Waljit S Dhillo, PhD, Imperial College London
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13HH0199
- 2012-000154-61 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
Gazi UniversityCompletedMale Infertility | Unexplained Infertility
-
King's College LondonNot yet recruitingInfertility | Infertility, Female | Infertility Unexplained | Infertility of Tubal Origin
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMale Infertility, AzoospermiaUnited States
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Istanbul University - Cerrahpasa (IUC)RecruitingInfertility | Sexual Dysfunction | Infertility, Male | Nurse's Role | Sexuality | Infertility; FemaleTurkey
Clinical Trials on Kisspeptin 1.6nmol/kg
-
Imperial College LondonRecruitingFertility Disorders | Hypothalamic DysfunctionUnited Kingdom
-
Stephanie B. Seminara, MDRecruitingPregnancy | Healthy Volunteers | Insulin | Glucose | WomenUnited States
-
Massachusetts General HospitalCompletedKallmann Syndrome | Hypogonadotropic Hypogonadism | Delayed Puberty | GnRH DeficiencyUnited States
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedInfertility, Female | Anovulation | Unexplained InfertilityTurkey
-
Quaid-e-Azam UniversityCompletedSterility, ReproductivePakistan
-
Quaid-e-Azam UniversityCompletedKisspeptin Action on Insulin in Healthy Normal Men | Kisspeptin Action on Insulin in Obese Diabetic Men
-
Ghulam NabiCompletedReproductive Physiological PhenomenaPakistan
-
Massachusetts General HospitalRecruitingMetabolic DiseaseUnited States
-
Massachusetts General HospitalRecruitingMetabolic DiseasesUnited States
-
Atridia Pty Ltd.Linear Clinical ResearchCompleted