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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT01667406 (opens ClinicalTrials.gov in a new tab)Other id13HH0199Other id2012-000154-61
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
175 participants (actual)
Sponsor
Imperial College London · Other
Design
Randomized · Double masking
Countries
1 country

United Kingdom

Start
1 Jun 2012
Primary completion
11 Oct 2016
Completion
11 Oct 2016
First posted
17 Aug 2012 (estimated)
Last update posted
8 Jun 2021
Conditions
Infertility

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014201520162017
  1. Ph 2

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

    NCT01667406

    1 Jun 2012 to 11 Oct 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Kisspeptin 1.6nmol/kgDrug
  • Kisspeptin 3.2nmol/kgDrug
  • Kisspeptin 6.4nmol/kgDrug
  • Kisspeptin 9.6nmol/kgDrug
  • Kisspeptin 12.8nmol/kgDrug
  • Kisspeptin 9.6 nmol/kg doubleDrug
  • Kisspeptin 9.6 nmol/kg + salineDrug

Arms10

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Oocyte Maturation

    Time frame · 36 hours post Kisspeptin-54 trigger injection

    Registry description

    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

Secondary outcomes(5)

  1. Biochemical Pregnancy

    Time frame · 11 days after embryo transfer

    Registry description

    Number of participants achieving biochemical pregnancy by serum βhCG \> 10 mIU/mL

  2. Occurrence of OHSS

    Time frame · 11 days following embryo transfer

    Registry description

    Women were routinely screened for the development of early OHSS and late OHSS. Women were screened by symptoms, blood analysis, and ultrasound parameters

  3. Fertilization Rate

    Time frame · 3 days after oocyte retrieval

    Registry description

    Percentage of M2 oocytes that fertilize to form two pronuclear \[2PN\] zygotes following intracytoplasmic injection with sperm \[ICSI\]

  4. Embryo Formation

    Time frame · 3 days after oocyte retrieval

    Registry description

    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

  5. Number of Participants With Clinical Pregnancy

    Time frame · 6 weeks after embryo transfer

    Registry description

    Intrauterine gestational sac with heartbeat on ultrasound at 6 weeks' gestation

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 36 hours post Kisspeptin-54 trigger injection

Percentage of Oocyte Maturation

GroupValue (percentage of expected oocyte yield)Spread
Kisspeptin-54 1.6 Nmol/kg Single4929
Kisspeptin-54 3.2nmol/kg Single3618
Kisspeptin-54 6.4 Nmol/kg Single7649
Kisspeptin-54 12.8nmol/kg Single10353
Kisspeptin-54, OHSS 3.2nmol/Kg Single5341
Kisspeptin-54, OHSS 6.4nmol/Kg Single8649
Kisspeptin-54, OHSS 9.6nmol/Kg Single8674
Kisspeptin-54, OHSS 12.8nmol/Kg Single121119
Kisspeptin-54 OHSS, 9.6 + 9.65518
Kisspeptin-54 OHSS, 9.6 + Saline4622
Secondary and other outcome results(5)
Secondary outcomeCount of participants· 11 days after embryo transfer

Biochemical Pregnancy

GroupValue (Participants)
KP-54 1.6nmol/kg Single1
KP-54 3.2nmol/kg Single1
KP-54 6.4nmol/kg Single11
KP-54 12.8nmol/kg Single8
KP-54 OHSS 3.2nmol/kg Single1
KP-54 OHSS 6.4nmol/kg Single10
KP-54 OHSS 9.6nmol/kg10
KP-54 OHSS 12.8nmol/kg Single6
KP-54 OHSS 9.6 +9.6 Nmol/kg16
KP-54 OHSS 9.6 + Saline10
Secondary outcomeCount of participants· 11 days following embryo transfer

Occurrence of OHSS

GroupValue (Participants)
Kisspeptin-54, 1.6 Single0
Kisspeptin-54, 3.2 Single0
Kisspeptin-54, 6.4 Single0
Kisspeptin-54, 12.8 Single0
Kisspeptin-54 OHSS, 3.2 Single0
Kisspeptin-54 OHSS, 6.4 Single0
Kisspeptin-54 OHSS, 9.6 Single0
Kisspeptin-54 OHSS, 12.8 Single4
Kisspeptin-54 OHSS, 9.6 + 9.61
Kisspeptin-54 OHSS, 9.6 + Saline1
Secondary outcomeMean· 3 days after oocyte retrieval

Fertilization Rate

GroupValue (percentage of 2PN zygotes)Spread
Kisspeptin-54 1.6 Single14.2820.20
Kispeptin-54 3.2 Single58.3330.04
Kisspeptin-54 6.4 Single66.9426.98
Kisspeptin-54 12.8 Single76.0126.28
OHSS - Kisspeptin-54 3.2 Single6839
OHSS - Kisspeptin-54 6.4 Single7629
OHSS - Kisspeptin-54 9.6 Single7433
OHSS - Kisspeptin-54 12.8 Single7321
Kisspeptin-54 9.6 + 9.678.626.2
Kisspeptin-54 9.6 + Saline78.937.7
Secondary outcomeMean· 3 days after oocyte retrieval

Embryo Formation

GroupValue (formed embryos)Spread
Kisspeptin-54 1.6 Single00
Kispeptin-54 3.2 Single2.332.31
Kisspeptin-54 6.4 Single3.82.7
Kisspeptin-54 12.8 Single4.52.7
OHSS - Kisspeptin-54 3.2 Single5.84.8
OHSS - Kisspeptin-54 6.4 Single9.47
OHSS - Kisspeptin-54 9.6 Single6.55.6
OHSS - Kisspeptin-54 12.8 Single11.18.4
Kisspeptin-54 9.6 + 9.664.44
Kisspeptin-54 9.6 + Saline53.70
Secondary outcomeCount of participants· 6 weeks after embryo transfer

Number of Participants With Clinical Pregnancy

GroupValue (Participants)
Kisspeptin-54 1.6 Single1
Kispeptin-54 3.2 Single0
Kisspeptin-54 6.4 Single7
Kisspeptin-54 12.8 Single4
OHSS - Kisspeptin-54 3.2 Single1
OHSS - Kisspeptin-54 6.4 Single10
OHSS - Kisspeptin-54 9.6 Single10
OHSS - Kisspeptin-54 12.8 Single6
Kisspeptin-54 9.6 + 9.67
Kisspeptin-54 9.6 + Saline12

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
KP-54 1.6nmol/kg SingleParticipants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 1.6nmol/kg as a trigger injection.0 / 20 / 20 / 2
KP-54 3.2nmol/kg SingleParticipants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 3.2nmol/kg as a trigger injection.0 / 30 / 30 / 3
KP-54 6.4nmol/kg SingleParticipants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 6.4nmol/kg as a trigger injection.0 / 241 / 240 / 24
KP-54 12.8nmol/kg SingleParticipants undergoing IVF treatment received a single injection of Kisspeptin-54, at a dose of 12.8nmol/kg as a trigger injection.0 / 242 / 240 / 24
KP-54 OHSS 3.2nmol/kg SingleParticipants 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 / 50 / 50 / 5
KP-54 OHSS 6.4nmol/kg SingleParticipants 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 / 201 / 200 / 20
KP-54 OHSS 9.6nmol/kg SingleParticipants 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 / 152 / 150 / 15
KP-54 OHSS 12.8nmol/kg SingleParticipants 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 / 202 / 200 / 20
KP-54 OHSS 9.6 + 9.6 Nmol/kgParticipant 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 later0 / 310 / 310 / 31
KP-54 OHSS 9.6nmol/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 later0 / 311 / 310 / 31

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Clinical trial · 2018

18 results

The direct and indirect effects of kisspeptin-54 on granulosa lutein cell function.

Owens et al. 2018Human reproduction (Oxford, England)cited by 37

PMID 29206944DOI 10.1093/humrep/dex357PUB-29206944

Full text at the publisher18 results
Publisher pageSee results (18)

Indexing hint: Randomized controlled trial · 2017

4 results

A second dose of kisspeptin-54 improves oocyte maturation in women at high risk of ovarian hyperstimulation syndrome: a Phase 2 randomized controlled trial.

Abbara et al. 2017Human reproduction (Oxford, England)cited by 49

PMID 28854728PMC5850304DOI 10.1093/humrep/dex253PUB-28854728

CC BY4 results
Download PDFSee results (4)

Indexing hint: Randomized controlled trial · 2015

10 results

Efficacy of Kisspeptin-54 to Trigger Oocyte Maturation in Women at High Risk of Ovarian Hyperstimulation Syndrome (OHSS) During In Vitro Fertilization (IVF) Therapy.

Abbara et al. 2015The Journal of clinical endocrinology and metabolismcited by 101

PMID 26192876PMC4570165DOI 10.1210/jc.2015-2332PUB-26192876

CC BY10 results
Download PDFSee results (10)

Indexing hint: Clinical trial · 2014

5 results

Kisspeptin-54 triggers egg maturation in women undergoing in vitro fertilization.

Jayasena et al. 2014The Journal of clinical investigationcited by 109

PMID 25036713PMC4109525DOI 10.1172/jci75730PUB-25036713

Rights unknown5 results
Source linkSee results (5)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedAbbara 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. PMID 29446481

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 34 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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