The Use of the Hormone Kisspeptin in IVF Treatment
Information source: Imperial College London
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: kisspeptin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Imperial College London Official(s) and/or principal investigator(s): Waljit S Dhillo, PhD, Principal Investigator, Affiliation: Imperial College London
Overall contact: Waljit S Dhillo, PhD, Phone: + 44 (0) 20 8383 2820, Email: w.dhillo@imperial.ac.uk
Summary
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.
Clinical Details
Official title: The Use of the Hormone Kisspeptin in IVF Treatment
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Oocyte maturation
Secondary outcome: Luteinising hormone (LH)Follicle Stimulation Hormone (FSH) Estradiol Ovarian follicular number Oocyte quality Embryo quality beta human chorionic gonadotropin (BhCG) Clinical pregnancy rate Fertilisation rate Live births
Detailed description:
Participants in the study will have a standard GnRH antagonist cycle except using kisspeptin
to trigger oocyte maturation rather than hCG.
Eligibility
Minimum age: 18 Years.
Maximum age: 34 Years.
Gender(s): Female.
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
Locations and Contacts
Waljit S Dhillo, PhD, Phone: + 44 (0) 20 8383 2820, Email: w.dhillo@imperial.ac.uk
Hammersmith Hospital, London W12 0NN, United Kingdom; Recruiting
Additional Information
Starting date: June 2012
Last updated: March 31, 2015
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