InfertilityPhase 2NCT01667406

The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment

A Phase 2 study testing Kisspeptin 1.6nmol/kg, Kisspeptin 3.2nmol/kg and Kisspeptin 6.4nmol/kg in people with Infertility, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 34 years, women only
Conditions the study is for: Infertility
What is being tested?: Kisspeptin 1.6nmol/kg, Kisspeptin 3.2nmol/kg and Kisspeptin 6.4nmol/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 175 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Jun 2012to 11 Oct 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 34 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Hammersmith Hospital
London, W12 0NN

Other trials in United Kingdom

About this study

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.

Read the 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

Conditions: Infertility
Being tested: Kisspeptin 1.6nmol/kg, Kisspeptin 3.2nmol/kg, Kisspeptin 6.4nmol/kg, Kisspeptin 9.6nmol/kg, Kisspeptin 12.8nmol/kg
Keywords: kisspeptin, infertility, in vitro fertilisation
Medical subject headings: Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Kisspeptin 1.6nmol/kgDrug
Also called kisspeptin-54
single kisspeptin dose 1.6 nmol/kg subcutaneously
Kisspeptin 3.2nmol/kgDrug
Also called kisspeptin-54
single kisspeptin dose 3.2 nmol/kg subcutaneously
Kisspeptin 6.4nmol/kgDrug
Also called kisspeptin-54
single kisspeptin dose 6.4 nmol/kg subcutaneously
Kisspeptin 9.6nmol/kgDrug
Also called kisspeptin-54
single kisspeptin dose 9.6 nmol/kg subcutaneously
Kisspeptin 12.8nmol/kgDrug
Also called kisspeptin-54
single kisspeptin dose 12.8 nmol/kg subcutaneously
Kisspeptin 9.6 nmol/kg doubleDrug
Also called kisspeptin-54
kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously
Kisspeptin 9.6 nmol/kg + salineDrug
Also called kisspeptin-54
kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart

Study groups in NCT01667406
Study group	Role	What they receive
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 Receives: Drug: Kisspeptin 1.6nmol/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 Receives: Drug: Kisspeptin 3.2nmol/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 Receives: Drug: Kisspeptin 6.4nmol/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 Receives: Drug: Kisspeptin 12.8nmol/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 Receives: Drug: Kisspeptin 3.2nmol/kg
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 Receives: Drug: Kisspeptin 6.4nmol/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 Receives: Drug: Kisspeptin 9.6nmol/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 Receives: Drug: Kisspeptin 12.8nmol/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 Receives: Drug: Kisspeptin 9.6 nmol/kg double
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 Receives: Drug: Kisspeptin 9.6 nmol/kg + saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 36 hours post Kisspeptin-54 trigger injection

Secondary outcomes (5)

Biochemical Pregnancy
Number of participants achieving biochemical pregnancy by serum βhCG > 10 mIU/mL
Measured: 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
Measured: 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]
Measured: 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
Measured: 3 days after oocyte retrieval
Number of Participants With Clinical Pregnancy
Intrauterine gestational sac with heartbeat on ultrasound at 6 weeks' gestation
Measured: 6 weeks after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201211 Oct 2016

First posted17 Aug 2012 (estimated)
Study start1 Jun 2012
Primary completion11 Oct 2016
Study completion11 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for InfertilityStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Different dose for each volunteer
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01667406
Sponsor's protocol ID: 13HH0199
Other IDs: 2012-000154-61
Status last verified: May 2021
First submitted: 8 Aug 2012
Last updated: 8 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will be presented in anonymised groups

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.
PubMed 25036713
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.
PubMed 28854728
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.
PubMed 26192876
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.
PubMed 29446481
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.
PubMed 29206944

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Infertility trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
ClinicalTrials.gov ID: NCT01667406
Acronym / sponsor ID: 13HH0199
Conditions: Infertility
Keywords: kisspeptin, infertility, in vitro fertilisation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Study start: 1 Jun 2012 (actual)
Primary completion: 11 Oct 2016 (actual)
Study completion: 11 Oct 2016 (actual)
First posted: 17 Aug 2012 (estimated)
Results: Posted 8 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 10
Model description: Different dose for each volunteer

Arm	Type	Receives
Kisspeptin-54, 1.6 single	Experimental	Drug: Kisspeptin 1.6nmol/kgParticipant 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	Drug: Kisspeptin 3.2nmol/kgParticipant 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	Drug: Kisspeptin 6.4nmol/kgParticipant 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	Drug: Kisspeptin 12.8nmol/kgParticipant 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	Drug: Kisspeptin 3.2nmol/kgParticipant 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-54 OHSS, 6.4 single	Experimental	Drug: Kisspeptin 6.4nmol/kgParticipant 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	Drug: Kisspeptin 9.6nmol/kgParticipant 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	Drug: Kisspeptin 12.8nmol/kgParticipant 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	Drug: Kisspeptin 9.6 nmol/kg doubleParticipant 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	Drug: Kisspeptin 9.6 nmol/kg + salineParticipant 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

Who may qualify

Ages: 18 to 34 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Kisspeptin 1.6nmol/kgAlso: kisspeptin-54single kisspeptin dose 1.6 nmol/kg subcutaneously	Drug	Kisspeptin-54, 1.6 single
Kisspeptin 3.2nmol/kgAlso: kisspeptin-54single kisspeptin dose 3.2 nmol/kg subcutaneously	Drug	Kisspeptin-54 OHSS, 3.2 single, Kisspeptin-54, 3.2 single
Kisspeptin 6.4nmol/kgAlso: kisspeptin-54single kisspeptin dose 6.4 nmol/kg subcutaneously	Drug	Kisspeptin-54 OHSS, 6.4 single, Kisspeptin-54, 6.4 single
Kisspeptin 9.6nmol/kgAlso: kisspeptin-54single kisspeptin dose 9.6 nmol/kg subcutaneously	Drug	Kisspeptin-54 OHSS, 9.6 single
Kisspeptin 12.8nmol/kgAlso: kisspeptin-54single kisspeptin dose 12.8 nmol/kg subcutaneously	Drug	Kisspeptin-54 OHSS, 12.8 single, Kisspeptin-54, 12.8 single
Kisspeptin 9.6 nmol/kg doubleAlso: kisspeptin-54kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously	Drug	Kisspeptin-54 OHSS, 9.6 + 9.6
Kisspeptin 9.6 nmol/kg + salineAlso: kisspeptin-54kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart	Drug	Kisspeptin-54 OHSS, 9.6 + saline

Primary outcome

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

5 secondary outcomes

Biochemical Pregnancy
Time frame: 11 days after embryo transfer
Occurrence of OHSS
Time frame: 11 days following embryo transfer
Fertilization Rate
Time frame: 3 days after oocyte retrieval
Embryo Formation
Time frame: 3 days after oocyte retrieval
Number of Participants With Clinical Pregnancy
Time frame: 6 weeks after embryo transfer

Results and safety

Results posted to the registry on 8 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Kisspeptin-54 1.6 Single	2	2
Kispeptin-54 3.2 Single	3	3
Kisspeptin-54 6.4 Single	24	24
Kisspeptin-54 12.8 Single	24	24
OHSS - Kisspeptin-54 3.2 Single	5	5
OHSS - Kisspeptin-54 6.4 Single	20	20
OHSS - Kisspeptin-54 9.6 Single	15	15
OHSS - Kisspeptin-54 12.8 Single	20	20
Kisspeptin-54 9.6 + 9.6	31	31
Kisspeptin-54 9.6 + Saline	31	31

Primary outcome: Percentage of Oocyte Maturation

Time frame: 36 hours post Kisspeptin-54 trigger injection. Mean (Standard Deviation). Unit: percentage of expected oocyte yield

Measure	Kisspeptin-54 1.6 Nmol/kg Single n = 2	Kisspeptin-54 3.2nmol/kg Single n = 3	Kisspeptin-54 6.4 Nmol/kg Single n = 24	Kisspeptin-54 12.8nmol/kg Single n = 24	Kisspeptin-54, OHSS 3.2nmol/Kg Single n = 5	Kisspeptin-54, OHSS 6.4nmol/Kg Single n = 20	Kisspeptin-54, OHSS 9.6nmol/Kg Single n = 15	Kisspeptin-54, OHSS 12.8nmol/Kg Single n = 20	Kisspeptin-54 OHSS, 9.6 + 9.6 n = 31	Kisspeptin-54 OHSS, 9.6 + Saline n = 31
Value	49 (29)	36 (18)	76 (49)	103 (53)	53 (41)	86 (49)	86 (74)	121 (119)	55 (18)	46 (22)

Kisspeptin-54 1.6 Nmol/kg Single vs Kisspeptin-54 3.2nmol/kg Single vs Kisspeptin-54 6.4 Nmol/kg Single vs Kisspeptin-54 12.8nmol/kg Single: Mean Difference (Final Values): 6
Kisspeptin-54, OHSS 3.2nmol/Kg Single vs Kisspeptin-54, OHSS 6.4nmol/Kg Single vs Kisspeptin-54, OHSS 9.6nmol/Kg Single: p <0.05, Fisher Exact
Kisspeptin-54 OHSS, 9.6 + 9.6 vs Kisspeptin-54 OHSS, 9.6 + Saline: Odds Ratio (OR): 0.05, p <0.05, Regression, Logistic

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
KP-54 1.6nmol/kg Single	0 of 2 (0%)	0 of 2 (0%)	0 of 2
KP-54 3.2nmol/kg Single	0 of 3 (0%)	0 of 3 (0%)	0 of 3
KP-54 6.4nmol/kg Single	1 of 24 (4.2%)	0 of 24 (0%)	0 of 24
KP-54 12.8nmol/kg Single	2 of 24 (8.3%)	0 of 24 (0%)	0 of 24
KP-54 OHSS 3.2nmol/kg Single	0 of 5 (0%)	0 of 5 (0%)	0 of 5
KP-54 OHSS 6.4nmol/kg Single	1 of 20 (5%)	0 of 20 (0%)	0 of 20
KP-54 OHSS 9.6nmol/kg Single	2 of 15 (13.3%)	0 of 15 (0%)	0 of 15
KP-54 OHSS 12.8nmol/kg Single	2 of 20 (10%)	0 of 20 (0%)	0 of 20
KP-54 OHSS 9.6 + 9.6 Nmol/kg	0 of 31 (0%)	0 of 31 (0%)	0 of 31
KP-54 OHSS 9.6nmol/kg + Saline	1 of 31 (3.2%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25036713Jayasena 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.
Results publication: PubMed 28854728Abbara 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.
Results publication: PubMed 26192876Abbara 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.
Derived from this study: PubMed 29446481Abbara 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.
Derived from this study: PubMed 29206944Owens 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.
Individual participant dataSharing planned: No. Data will be presented in anonymised groups

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Waljit S Dhillo, PhD principal investigator

Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Kisspeptin 1.6nmol/kg, Kisspeptin 3.2nmol/kg and Kisspeptin 6.4nmol/kg in people with Infertility, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Oocyte Maturation (time frame: 36 hours post Kisspeptin-54 trigger injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01667406, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.