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

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. Read our disclaimer for details. Identifier: NCT01667406
Recruitment Status : Unknown
Verified August 2016 by Imperial College London.
Recruitment status was:  Recruiting
First Posted : August 17, 2012
Last Update Posted : August 31, 2016
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Drug: kisspeptin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: N/A
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
Study Start Date : June 2012
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Infertility

Arm Intervention/treatment
Experimental: kisspeptin
Drug: kisspeptin
kisspeptin doses between 1.6 and 12.8 nmol/kg subcutaneously
Other Name: kisspeptin-54

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

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

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

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

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

  8. Clinical pregnancy rate [ Time Frame: three years ]
  9. Fertilisation rate [ Time Frame: three years ]
  10. Live births [ Time Frame: three years ]

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

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

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 identifier (NCT number): NCT01667406

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Contact: Waljit S Dhillo, PhD + 44 (0) 20 8383 2820
Contact: Steve R Bloom, PhD + 44 (0) 208 383 3242

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United Kingdom
Hammersmith Hospital Recruiting
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
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Principal Investigator: Waljit S Dhillo, PhD Imperial College London
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Imperial College London Identifier: NCT01667406    
Other Study ID Numbers: CRO1473
2012-000154-61 ( EudraCT Number )
First Posted: August 17, 2012    Key Record Dates
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:
in vitro fertilisation
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female