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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667406
• Other study ID #: 13HH0199
• Secondary ID: 2012-000154-61
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2012
• Est. completion date: October 11, 2016

Study information

• Verified date: May 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: October 11, 2016
• Est. primary completion date: October 11, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Kisspeptin 1.6nmol/kg
single kisspeptin dose 1.6 nmol/kg subcutaneously
• Kisspeptin 3.2nmol/kg
single kisspeptin dose 3.2 nmol/kg subcutaneously
• Kisspeptin 6.4nmol/kg
single kisspeptin dose 6.4 nmol/kg subcutaneously
• Kisspeptin 9.6nmol/kg
single kisspeptin dose 9.6 nmol/kg subcutaneously
• Kisspeptin 12.8nmol/kg
single kisspeptin dose 12.8 nmol/kg subcutaneously
• Kisspeptin 9.6 nmol/kg double
kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously
• Kisspeptin 9.6 nmol/kg + saline
kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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 improv — View 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 — View 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 vit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Oocyte Maturation	This was assessed by oocyte yield (percentage of mature [metaphase 2; M2] oocytes collected from the number of follicles = 14 mm on final ultrasound scan prior to kisspeptin-54 trigger administration	36 hours post Kisspeptin-54 trigger injection
Secondary	Biochemical Pregnancy	Number of participants achieving biochemical pregnancy by serum ßhCG > 10 mIU/mL	11 days after embryo transfer
Secondary	Occurrence of OHSS	Women were routinely screened for the development of early OHSS and late OHSS. Women were screened by symptoms, blood analysis, and ultrasound parameters	11 days following embryo transfer
Secondary	Fertilization Rate	Percentage of M2 oocytes that fertilize to form two pronuclear [2PN] zygotes following intracytoplasmic injection with sperm [ICSI]	3 days after oocyte retrieval
Secondary	Embryo Formation	All embryos were graded at day 3 by an independent embryologist, blinded to doses of kisspeptin administered, using the British Fertility Society and Association of Clinical Embryologist embryo grading scheme for cleavage stage embryos, which describes embryos based on cell number, blastomere size, and fragmentation	3 days after oocyte retrieval
Secondary	Number of Participants With Clinical Pregnancy	Intrauterine gestational sac with heartbeat on ultrasound at 6 weeks' gestation	6 weeks after embryo transfer