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

This study is currently recruiting participants.
Verified August 2016 by Imperial College London
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667406
First Posted: August 17, 2012
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Imperial College London
  Purpose
Infertility affects one in six couples in the United Kingdom (UK) and has devastating physical, social and emotional consequences for affected couples. In vitro fertilisation (IVF) treatment is now widely and successfully used to enable infertile couples to conceive. However, IVF treatment can result in the potentially life threatening condition, ovarian hyperstimulation syndrome (OHSS). Mild forms of OHSS occur in approximately 1 in 3 of all IVF cycles, whilst approximately 1 in 10 IVF cycles result in moderate or severe OHSS. OHSS is caused by the use of human chorionic gonadotrophin (hCG) used in IVF treatment to stimulate oocyte (egg) maturation. Kisspeptin is a hormone which stimulates reproductive hormone secretion and is responsible for the release of reproductive hormones which result in oocyte maturation and ovulation (the release of an egg from the ovary). The significant advantage of kisspeptin over current treatments to stimulate ovulation, is that it would stimulate a more physiological increase in reproductive hormones and oocyte maturation during IVF treatment. The aims of this project are to investigate whether administration of kisspeptin to women can result in oocyte maturation.

Condition Intervention Phase
Infertility Drug: kisspeptin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Oocyte maturation [ Time Frame: three years ]
    Oocyte maturation following kisspeptin administration


Secondary Outcome Measures:
  • Luteinising hormone (LH) [ Time Frame: three years ]
    levels of serum LH

  • Follicle Stimulation Hormone (FSH) [ Time Frame: three years ]
    levels of serum FSH

  • Estradiol [ Time Frame: three years ]
    levels of serum estradiol

  • Ovarian follicular number [ Time Frame: three years ]
  • Oocyte quality [ Time Frame: three years ]
  • Embryo quality [ Time Frame: three years ]
  • beta human chorionic gonadotropin (BhCG) [ Time Frame: three years ]
    beta human chorionic gonadotropin (BhCG) concentration after embryo transfer

  • Clinical pregnancy rate [ Time Frame: three years ]
  • Fertilisation rate [ Time Frame: three years ]
  • Live births [ Time Frame: three years ]

Estimated Enrollment: 102
Study Start Date: June 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: kisspeptin
kisspeptin
Drug: kisspeptin
kisspeptin doses between 1.6 and 12.8 nmol/kg subcutaneously
Other Name: kisspeptin-54

Detailed Description:
Participants in the study will have a standard Gonadotrophin Releasing Hormone (GnRH) antagonist cycle except using kisspeptin to trigger oocyte maturation rather than hCG.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667406


Contacts
Contact: Waljit S Dhillo, PhD + 44 (0) 20 8383 2820 w.dhillo@imperial.ac.uk
Contact: Steve R Bloom, PhD + 44 (0) 208 383 3242 s.bloom@imperial.ac.uk

Locations
United Kingdom
Hammersmith Hospital Recruiting
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Waljit S Dhillo, PhD Imperial College London
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01667406     History of Changes
Other Study ID Numbers: CRO1473
2012-000154-61 ( EudraCT Number )
First Submitted: August 8, 2012
First Posted: August 17, 2012
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be presented in anonymised groups

Keywords provided by Imperial College London:
kisspeptin
infertility
in vitro fertilisation

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs