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 A, Jayasena CN, Christopoulos G, Narayanaswamy S, Izzi-Engbeaya C, Nijher GM, Comninos AN, Peters D, Buckley A, Ratnasabapathy R, Prague JK, Salim R and 6 more

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Lavery SA, Bloom SR, Szigeti M, Ashby DA, Trew GH, Dhillo WS

The Journal of clinical endocrinology and metabolism20 Jul 2015Cited by 101 (Europe PMC)

PMID26192876PMCIDPMC4570165DOI10.1210/jc.2015-2332PepBankPUB-26192876

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Summary

ContextIn vitro fertilization (IVF) treatment is an effective therapy for infertility, but can result in the potentially life-threatening complication, ovarian hyperstimulation syndrome (OHSS).ObjectiveThis study aimed to investigate whether kisspeptin-54 can be used to effectively and safely trigger oocyte maturation in women undergoing IVF treatment at high risk of developing OHSS.Setting and designThis was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013-2014 at Hammersmith Hospital IVF unit, London, United Kingdom.InterventionFollowing a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20). Oocytes were retrieved 36 h after kisspeptin-54 administration, assessed for maturation, and fertilized by intracytoplasmic sperm injection with subsequent transfer of one or two embryos. Women were routinely screened for the development of OHSS.Main outcome measureOocyte maturation was measured by oocyte yield (percentage of mature oocytes retrieved from follicles ≥ 14 mm on ultrasound). Secondary outcomes include rates of OHSS and pregnancy.ResultsOocyte maturation occurred in 95% of women. Highest oocyte yield (121%) was observed following 12.8 nmol/kg kisspeptin-54, which was +69% (confidence interval, -16-153%) greater than following 3.2 nmol/kg. At all doses of kisspeptin-54, biochemical pregnancy, clinical pregnancy, and live birth rates per transfer (n = 51) were 63, 53, and 45%, respectively. Highest pregnancy rates were observed following 9.6 nmol/kg kisspeptin-54 (85, 77, and 62%, respectively). No woman developed moderate, severe, or critical OHSS.ConclusionKisspeptin-54 is a promising approach to effectively and safely trigger oocyte maturation in women undergoing IVF treatment at high risk of developing OHSS.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In women at high risk of OHSS having IVF, oocyte maturation occurred in 95% of women after a single kisspeptin‑54 injection.
In plain wordsIn women at high risk of ovarian overstimulation having IVF, eggs matured in 95% of women after one kisspeptin‑54 injection.
Peptide
Kisspeptin-54 (metastin)
Outcome
Not applicableOocyte maturation rate
Study
n = 60
Analysis
Primary
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
3.2, 6.4, 9.6 or 12.8 nmol/kgAs given in this study (human).
Measurements
Oocyte maturation
95%
all doses
Source sentences
Summary
Oocyte maturation occurred in 95% of women.
3 context sentences(design, population, supporting numbers)
Summary · context
Oocyte maturation was measured by oocyte yield (percentage of mature oocytes retrieved from follicles ≥ 14 mm on ultrasound).
Summary · context
This was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013-2014 at Hammersmith Hospital IVF unit, London, United Kingdom.
Summary · context
Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20).
Show in the study text Report a problemFND-2619287601
02HumanRandomized controlled trialSafety outcome
In women at high risk of OHSS having IVF, no woman developed moderate, severe or critical OHSS after kisspeptin‑54.
In plain wordsIn women at high risk of ovarian overstimulation having IVF, no woman developed moderate, severe or critical overstimulation after kisspeptin‑54.
Peptide
Kisspeptin-54 (metastin)
Outcome
No significant changeModerate, severe or critical OHSS
Study
n = 60
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
3.2, 6.4, 9.6 or 12.8 nmol/kgAs given in this study (human).
Source sentences
Summary
No woman developed moderate, severe, or critical OHSS.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013-2014 at Hammersmith Hospital IVF unit, London, United Kingdom.
Summary · context
Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20).
Show in the study text Report a problemFND-2619287610
03HumanRandomized controlled trialEfficacy outcome
In women at high risk of OHSS having IVF, the biochemical pregnancy rate per transfer across all kisspeptin‑54 doses was 63%.
In plain wordsIn women at high risk of ovarian overstimulation having IVF, 63% of embryo transfers led to a biochemical pregnancy across all doses.
Peptide
Kisspeptin-54 (metastin)
Outcome
Not applicableBiochemical pregnancy rate per transfer, all doses
Study
n = 51
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
3.2, 6.4, 9.6 or 12.8 nmol/kgAs given in this study (human).
Measurements
Biochemical pregnancy rate per transfer
63%
all doses
Source sentences
Summary
At all doses of kisspeptin-54, biochemical pregnancy, clinical pregnancy, and live birth rates per transfer (n = 51) were 63, 53, and 45%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013-2014 at Hammersmith Hospital IVF unit, London, United Kingdom.
Summary · context
Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20).
Show in the study text Report a problemFND-2619287604
04HumanRandomized controlled trialEfficacy outcome
In women at high risk of OHSS having IVF, the clinical pregnancy rate per transfer across all kisspeptin‑54 doses was 53%.
In plain wordsIn women at high risk of ovarian overstimulation having IVF, 53% of embryo transfers led to a clinical pregnancy across all doses.
Peptide
Kisspeptin-54 (metastin)
Outcome
Not applicableClinical pregnancy rate per transfer, all doses
Study
n = 51
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
3.2, 6.4, 9.6 or 12.8 nmol/kgAs given in this study (human).
Measurements
Clinical pregnancy rate per transfer
53%
all doses
Source sentences
Summary
At all doses of kisspeptin-54, biochemical pregnancy, clinical pregnancy, and live birth rates per transfer (n = 51) were 63, 53, and 45%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013-2014 at Hammersmith Hospital IVF unit, London, United Kingdom.
Summary · context
Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20).
Show in the study text Report a problemFND-2619287605
05HumanRandomized controlled trialEfficacy outcome
In women at high risk of OHSS having IVF, the live birth rate per transfer across all kisspeptin‑54 doses was 45%.
In plain wordsIn women at high risk of ovarian overstimulation having IVF, 45% of embryo transfers led to a live birth across all doses.
Peptide
Kisspeptin-54 (metastin)
Outcome
Not applicableLive birth rate per transfer, all doses
Study
n = 51
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
3.2, 6.4, 9.6 or 12.8 nmol/kgAs given in this study (human).
Measurements
Live birth rate per transfer
45%
all doses
Source sentences
Summary
At all doses of kisspeptin-54, biochemical pregnancy, clinical pregnancy, and live birth rates per transfer (n = 51) were 63, 53, and 45%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013-2014 at Hammersmith Hospital IVF unit, London, United Kingdom.
Summary · context
Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20).
Show in the study text Report a problemFND-2619287606
06HumanRandomized controlled trialEfficacy outcome
In women at high risk of OHSS having IVF, oocyte yield after 12.8 nmol/kg was 69% greater than after 3.2 nmol/kg, with a confidence interval of -16-153%.
In plain wordsIn women at high risk of overstimulation having IVF, egg yield was higher at 12.8 than at 3.2 nmol/kg, but the range included zero.
Peptide
Kisspeptin-54 (metastin)
Outcome
No significant changeOocyte yield at 12.8 versus 3.2 nmol/kg
Study
n = 25
Comparator
3.2 nmol/kg
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
12.8 nmol/kgAs given in this study (human).
Measurements
Difference in oocyte yield
69%
12.8 versus 3.2 nmol/kg
Source sentences
Summary
Highest oocyte yield (121%) was observed following 12.8 nmol/kg kisspeptin-54, which was +69% (confidence interval, -16-153%) greater than following 3.2 nmol/kg.
3 context sentences(design, population, supporting numbers)
Summary · context
Oocyte maturation was measured by oocyte yield (percentage of mature oocytes retrieved from follicles ≥ 14 mm on ultrasound).
Summary · context
This was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013-2014 at Hammersmith Hospital IVF unit, London, United Kingdom.
Summary · context
Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20).
Show in the study text Report a problemFND-2619287603
07HumanRandomized controlled trialEfficacy outcome
In women at high risk of OHSS having IVF, the highest oocyte yield (121%) was seen after 12.8 nmol/kg kisspeptin‑54.
In plain wordsIn women at high risk of ovarian overstimulation having IVF, the highest egg yield was seen at the 12.8 nmol/kg dose.
Peptide
Kisspeptin-54 (metastin)
Outcome
Not applicableOocyte yield at 12.8 nmol/kg
Study
n = 20
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
12.8 nmol/kgAs given in this study (human).
Measurements
Oocyte yield
121%
12.8 nmol/kg
Source sentences
Summary
Highest oocyte yield (121%) was observed following 12.8 nmol/kg kisspeptin-54
3 context sentences(design, population, supporting numbers)
Summary · context
Oocyte maturation was measured by oocyte yield (percentage of mature oocytes retrieved from follicles ≥ 14 mm on ultrasound).
Summary · context
This was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013-2014 at Hammersmith Hospital IVF unit, London, United Kingdom.
Summary · context
Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20).
Show in the study text Report a problemFND-2619287602
08HumanRandomized controlled trialEfficacy outcome
In women at high risk of OHSS having IVF, the highest biochemical pregnancy rate (85%) was seen after 9.6 nmol/kg kisspeptin‑54.
In plain wordsIn women at high risk of ovarian overstimulation having IVF, the 9.6 nmol/kg dose had the highest biochemical pregnancy rate, 85%.
Peptide
Kisspeptin-54 (metastin)
Outcome
Not applicableBiochemical pregnancy rate at 9.6 nmol/kg
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
9.6 nmol/kgAs given in this study (human).
Measurements
Biochemical pregnancy rate
85%
9.6 nmol/kg
Source sentences
Summary
Highest pregnancy rates were observed following 9.6 nmol/kg kisspeptin-54 (85, 77, and 62%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013-2014 at Hammersmith Hospital IVF unit, London, United Kingdom.
Summary · context
Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20).
Show in the study text Report a problemFND-2619287607
09HumanRandomized controlled trialEfficacy outcome
In women at high risk of OHSS having IVF, the highest clinical pregnancy rate (77%) was seen after 9.6 nmol/kg kisspeptin‑54.
In plain wordsIn women at high risk of ovarian overstimulation having IVF, the 9.6 nmol/kg dose had the highest clinical pregnancy rate, 77%.
Peptide
Kisspeptin-54 (metastin)
Outcome
Not applicableClinical pregnancy rate at 9.6 nmol/kg
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
9.6 nmol/kgAs given in this study (human).
Measurements
Clinical pregnancy rate
77%
9.6 nmol/kg
Source sentences
Summary
Highest pregnancy rates were observed following 9.6 nmol/kg kisspeptin-54 (85, 77, and 62%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013-2014 at Hammersmith Hospital IVF unit, London, United Kingdom.
Summary · context
Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20).
Show in the study text Report a problemFND-2619287608
10HumanRandomized controlled trialEfficacy outcome
In women at high risk of OHSS having IVF, the highest live birth rate (62%) was seen after 9.6 nmol/kg kisspeptin‑54.
In plain wordsIn women at high risk of ovarian overstimulation having IVF, the 9.6 nmol/kg dose had the highest live birth rate, 62%.
Peptide
Kisspeptin-54 (metastin)
Outcome
Not applicableLive birth rate at 9.6 nmol/kg
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
9.6 nmol/kgAs given in this study (human).
Measurements
Live birth rate
62%
9.6 nmol/kg
Source sentences
Summary
Highest pregnancy rates were observed following 9.6 nmol/kg kisspeptin-54 (85, 77, and 62%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013-2014 at Hammersmith Hospital IVF unit, London, United Kingdom.
Summary · context
Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20).
Show in the study text Report a problemFND-2619287609

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT01667406

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

Imperial College Londonn = 1751 Jun 2012 to 11 Oct 2016

Infertility

Trial page ClinicalTrials.govUpdated 8 Jun 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
13 Oct 2026, 21:44 UTC
Study results updated
Version 1
13 Oct 2026, 16:31 UTC
First added · source update from Europe PMC

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