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

Imperial College London175 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

175

Conditions

Infertility

Interventions

Kisspeptin 1.6nmol/kgDRUG

single kisspeptin dose 1.6 nmol/kg subcutaneously

Kisspeptin 3.2nmol/kgDRUG

single kisspeptin dose 3.2 nmol/kg subcutaneously

Kisspeptin 6.4nmol/kgDRUG

single kisspeptin dose 6.4 nmol/kg subcutaneously

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 34 Years

Medical Language ↔ Plain English

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

Locations (1)

Hammersmith Hospital

London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 36 hours post Kisspeptin-54 trigger injection

Secondary Outcomes

Biochemical Pregnancy

Number of participants achieving biochemical pregnancy by serum βhCG \> 10 mIU/mL

Time frame: 11 days after embryo transfer

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

Time frame: 11 days following embryo transfer

Fertilization Rate

Percentage of M2 oocytes that fertilize to form two pronuclear \[2PN\] zygotes following intracytoplasmic injection with sperm \[ICSI\]

Time frame: 3 days after oocyte retrieval

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

Time frame: 3 days after oocyte retrieval

Number of Participants With Clinical Pregnancy

Intrauterine gestational sac with heartbeat on ultrasound at 6 weeks' gestation

Time frame: 6 weeks after embryo transfer

Data from ClinicalTrials.gov

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