The Use of the Hormone Kisspeptin in IVF Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01667406
First received: August 8, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

Infertility affects one in six couples in the 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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of the Hormone Kisspeptin in 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 ] [ Designated as safety issue: No ]
    Oocyte maturation following kissppetin administration


Secondary Outcome Measures:
  • Luteinising hormone (LH) [ Time Frame: three years ] [ Designated as safety issue: No ]
    levels of serum LH

  • Follicle Stimulation Hormone (FSH) [ Time Frame: three years ] [ Designated as safety issue: No ]
    levels of serum FSH

  • Estradiol [ Time Frame: three years ] [ Designated as safety issue: No ]
    levels of serum estradiol

  • Ovarian follicular number [ Time Frame: three years ] [ Designated as safety issue: No ]
  • Oocyte quality [ Time Frame: three years ] [ Designated as safety issue: No ]
  • Embryo quality [ Time Frame: three years ] [ Designated as safety issue: No ]
  • beta human chorionic gonadotropin (BhCG) [ Time Frame: three years ] [ Designated as safety issue: No ]
    beta human chorionic gonadotropin (BhCG) concentration after embryo transfer

  • Clinical pregnancy rate [ Time Frame: three years ] [ Designated as safety issue: No ]
  • Fertilisation rate [ Time Frame: three years ] [ Designated as safety issue: No ]
  • Live births [ Time Frame: three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: kisspeptin
kisspeptin
Drug: kisspeptin

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders 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) > 10pmol/L
  • No more than one previous IVF treatment cycle
  • Both ovaries intact
  • Normal menstrual cycles ranging from 24-35 days in length

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Imperial College London

Additional 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
Study First Received: August 8, 2012
Last Updated: May 20, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Research Ethics Service Committee West London

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 23, 2014