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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

Page last updated: August 23, 2015

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