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

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: Kisspeptin 1.6nmol/kg; Drug: Kisspeptin 3.2nmol/kg; Drug: Kisspeptin 6.4nmol/kg; Drug: Kisspeptin 12.8nmol/kg; Drug: Kisspeptin 9.6nmol/kg; Drug: Kisspeptin 9.6 nmol/kg double; Drug: Kisspeptin 9.6 nmol/kg + saline

• Registration Number: NCT01667406
• Lead Sponsor: Imperial College London

Brief 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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06-01
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Primary Completion: 2016-10-11
• Study Completion: 2016-10-11
• Results First Submitted: 2019-03-01
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Results First Posted: 2021-06-08
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 175

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kisspeptin-54, 1.6 single	Kisspeptin 1.6nmol/kg	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	Kisspeptin 3.2nmol/kg	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	Kisspeptin 6.4nmol/kg	Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg
Kisspeptin-54 OHSS, 6.4 single	Kisspeptin 6.4nmol/kg	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, 12.8 single	Kisspeptin 12.8nmol/kg	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	Kisspeptin 3.2nmol/kg	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-54 OHSS, 9.6 single	Kisspeptin 9.6nmol/kg	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	Kisspeptin 12.8nmol/kg	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	Kisspeptin 9.6 nmol/kg double	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	Kisspeptin 9.6 nmol/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

Primary Outcome Measures

Name	Time	Method
Percentage of Oocyte Maturation	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

Secondary Outcome Measures

Name	Time	Method
Biochemical Pregnancy	11 days after embryo transfer	Number of participants achieving biochemical pregnancy by serum βhCG \> 10 mIU/mL
Occurrence of OHSS	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
Fertilization Rate	3 days after oocyte retrieval	Percentage of M2 oocytes that fertilize to form two pronuclear \[2PN\] zygotes following intracytoplasmic injection with sperm \[ICSI\]
Embryo Formation	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
Number of Participants With Clinical Pregnancy	6 weeks after embryo transfer	Intrauterine gestational sac with heartbeat on ultrasound at 6 weeks' gestation

Trial Locations

Locations (1)

Hammersmith Hospital; 🇬🇧 London, United Kingdom