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

May 13, 2021 updated by: Imperial College London
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.

Study Overview

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

Interventional

Enrollment (Actual)

175

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • kisspeptin-54
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:
  • kisspeptin-54
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:
  • kisspeptin-54
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:
  • kisspeptin-54
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:
  • kisspeptin-54
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:
  • kisspeptin-54
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:
  • kisspeptin-54
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:
  • kisspeptin-54
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:
  • kisspeptin-54
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:
  • kisspeptin-54

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Waljit S Dhillo, PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

October 11, 2016

Study Completion (Actual)

October 11, 2016

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

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)?

No

IPD Plan Description

Data will be presented in anonymised groups

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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