Clinical trial NCT01667406: The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
Official title: The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: kisspeptin
infertility
in vitro fertilisation
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Different dose for each volunteer
Primary purpose: TREATMENT

Brief summary: We want to find out if kisspeptin is successful in stimulating oocyte maturation when it is used as a 'trigger' injection during IVF therapy for infertility.

Detailed description: Participants in the study will have a standard Gonadotrophin Releasing Hormone (GnRH) antagonist IVF cycle, but instead of having a trigger injection of hCG (human chorionic gonadotrophin) they will be randomised to receive one of 4 doses of kisspeptin injection.

Oocytes will be retrieved and graded by an embryologist to see whether or not they have matured.

The reproductive hormones Luteinising hormone, follicle stimulating hormone, oestradiol and progesterone will also be measured

Eligibility 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

Primary outcomes:
measure: Percentage of Oocyte Maturation
timeFrame: 36 hours post Kisspeptin-54 trigger injection
Secondary outcomes:
measure: Biochemical Pregnancy
timeFrame: 11 days after embryo transfer
measure: Occurrence of OHSS
timeFrame: 11 days following embryo transfer
measure: Fertilization Rate
timeFrame: 3 days after oocyte retrieval
measure: Embryo Formation
timeFrame: 3 days after oocyte retrieval
measure: Number of Participants With Clinical Pregnancy
timeFrame: 6 weeks after embryo transfer
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Imperial College London
name: Waljit S Dhillo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jayasena CN, Abbara A, Comninos AN, Nijher GM, Christopoulos G, Narayanaswamy S, Izzi-Engbeaya C, Sridharan M, Mason AJ, Warwick J, Ashby D, Ghatei MA, Bloom SR, Carby A, Trew GH, Dhillo WS. Kisspeptin-54 triggers egg maturation in women undergoing in vitro fertilization. J Clin Invest. 2014 Aug;124(8):3667-77. doi: 10.1172/JCI75730. Epub 2014 Jul 18.
citation: Abbara A, Clarke S, Islam R, Prague JK, Comninos AN, Narayanaswamy S, Papadopoulou D, Roberts R, Izzi-Engbeaya C, Ratnasabapathy R, Nesbitt A, Vimalesvaran S, Salim R, Lavery SA, Bloom SR, Huson L, Trew GH, Dhillo WS. A second dose of kisspeptin-54 improves oocyte maturation in women at high risk of ovarian hyperstimulation syndrome: a Phase 2 randomized controlled trial. Hum Reprod. 2017 Sep 1;32(9):1915-1924. doi: 10.1093/humrep/dex253.
citation: Abbara A, Jayasena CN, Christopoulos G, Narayanaswamy S, Izzi-Engbeaya C, Nijher GM, Comninos AN, Peters D, Buckley A, Ratnasabapathy R, Prague JK, Salim R, Lavery SA, Bloom SR, Szigeti M, Ashby DA, Trew GH, Dhillo WS. Efficacy of Kisspeptin-54 to Trigger Oocyte Maturation in Women at High Risk of Ovarian Hyperstimulation Syndrome (OHSS) During In Vitro Fertilization (IVF) Therapy. J Clin Endocrinol Metab. 2015 Sep;100(9):3322-31. doi: 10.1210/jc.2015-2332. Epub 2015 Jul 20.
citation: Abbara A, Islam R, Clarke SA, Jeffers L, Christopoulos G, Comninos AN, Salim R, Lavery SA, Vuong TNL, Humaidan P, Kelsey TW, Trew GH, Dhillo WS. Clinical parameters of ovarian hyperstimulation syndrome following different hormonal triggers of oocyte maturation in IVF treatment. Clin Endocrinol (Oxf). 2018 Jun;88(6):920-927. doi: 10.1111/cen.13569. Epub 2018 Mar 6.
citation: Owens LA, Abbara A, Lerner A, O'floinn S, Christopoulos G, Khanjani S, Islam R, Hardy K, Hanyaloglu AC, Lavery SA, Dhillo WS, Franks S. The direct and indirect effects of kisspeptin-54 on granulosa lutein cell function. Hum Reprod. 2018 Feb 1;33(2):292-302. doi: 10.1093/humrep/dex357.