Phase 2
N=175
The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01667406 ↗Enrolled (actual)
175
Serious AEs
5.1%
Results posted
Jun 2021
Primary outcome: Primary: Percentage of Oocyte Maturation — 49; 36; 76; 103 percentage of expected oocyte yield — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Kisspeptin 1.6nmol/kg (Drug); Kisspeptin 3.2nmol/kg (Drug); Kisspeptin 6.4nmol/kg (Drug); Kisspeptin 9.6nmol/kg (Drug); Kisspeptin 12.8nmol/kg (Drug); Kisspeptin 9.6 nmol/kg double (Drug); Kisspeptin 9.6 nmol/kg + saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Imperial College London
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Oocyte Maturation |
49; 36; 76; 103; 53; 86 | <0.05 sig |
| SECONDARY Biochemical Pregnancy |
1; 1; 11; 8; 1; 10 | — |
| SECONDARY Occurrence of OHSS |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Fertilization Rate |
14.28; 58.33; 66.94; 76.01; 68; 76 | — |
| SECONDARY Embryo Formation |
0; 2.33; 3.8; 4.5; 5.8; 9.4 | — |
| SECONDARY Number of Participants With Clinical Pregnancy |
1; 0; 7; 4; 1; 10 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01667406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.