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

Imperial College London

Status and phase: Completed; Phase 2

Conditions: Infertility

Treatments: Drug: Kisspeptin 1.6nmol/kg; Drug: Kisspeptin 12.8nmol/kg; Drug: Kisspeptin 9.6 nmol/kg + saline; Drug: Kisspeptin 3.2nmol/kg; Drug: Kisspeptin 6.4nmol/kg; Drug: Kisspeptin 9.6 nmol/kg double; Drug: Kisspeptin 9.6nmol/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT01667406

2012-000154-61 (EudraCT Number)

13HH0199

Details and patient eligibility

About

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.

Full 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

Enrollment: 175 patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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175 participants in 10 patient groups

Kisspeptin-54, 1.6 single

Experimental group

Description:

Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 1.6 nmol/kg

Treatment:

Drug: Kisspeptin 1.6nmol/kg

Kisspeptin-54, 3.2 single

Experimental group

Description:

Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg

Treatment:

Drug: Kisspeptin 3.2nmol/kg

Kisspeptin-54, 6.4 single

Experimental group

Description:

Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg

Treatment:

Drug: Kisspeptin 6.4nmol/kg

Kisspeptin-54, 12.8 single

Experimental group

Description:

Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg

Treatment:

Drug: Kisspeptin 12.8nmol/kg

Kisspeptin-54 OHSS, 3.2 single

Experimental group

Description:

Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg

Treatment:

Drug: Kisspeptin 3.2nmol/kg

Kisspeptin-54 OHSS, 6.4 single

Experimental group

Description:

Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg

Treatment:

Drug: Kisspeptin 6.4nmol/kg

Kisspeptin-54 OHSS, 9.6 single

Experimental group

Description:

Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg

Treatment:

Drug: Kisspeptin 9.6nmol/kg

Kisspeptin-54 OHSS, 12.8 single

Experimental group

Description:

Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg

Treatment:

Drug: Kisspeptin 12.8nmol/kg

Kisspeptin-54 OHSS, 9.6 + 9.6

Experimental group

Description:

Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later

Treatment:

Drug: Kisspeptin 9.6 nmol/kg double

Kisspeptin-54 OHSS, 9.6 + saline

Experimental group

Description:

Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later

Treatment:

Drug: Kisspeptin 9.6 nmol/kg + saline