Infertility Clinical Trial
Official title:
The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
Verified date | May 2021 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hammersmith Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
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
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 |
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