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OpenTrials
Completed

NCT Number: NCT01667406

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–34 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hammersmith Hospital

London, W12 0NN, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kisspeptin 1.6nmol/kg

Drug

single kisspeptin dose 1.6 nmol/kg subcutaneously

Other names: kisspeptin-54

Kisspeptin 3.2nmol/kg

Drug

single kisspeptin dose 3.2 nmol/kg subcutaneously

Other names: kisspeptin-54

Kisspeptin 6.4nmol/kg

Drug

single kisspeptin dose 6.4 nmol/kg subcutaneously

Other names: kisspeptin-54

Kisspeptin 9.6nmol/kg

Drug

single kisspeptin dose 9.6 nmol/kg subcutaneously

Other names: kisspeptin-54

Kisspeptin 12.8nmol/kg

Drug

single kisspeptin dose 12.8 nmol/kg subcutaneously

Other names: kisspeptin-54

Kisspeptin 9.6 nmol/kg double

Drug

kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously

Other names: kisspeptin-54

Kisspeptin 9.6 nmol/kg + saline

Drug

kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart

Other names: kisspeptin-54

Primary outcomes

  1. Percentage of Oocyte Maturation

    Time frame: 36 hours post Kisspeptin-54 trigger injection

    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

Secondary outcomes

  1. Biochemical Pregnancy

    Time frame: 11 days after embryo transfer

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

  2. Occurrence of OHSS

    Time frame: 11 days following embryo transfer

    Women were routinely screened for the development of early OHSS and late OHSS. Women were screened by symptoms, blood analysis, and ultrasound parameters

  3. Fertilization Rate

    Time frame: 3 days after oocyte retrieval

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

  4. Embryo Formation

    Time frame: 3 days after oocyte retrieval

    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

  5. Number of Participants With Clinical Pregnancy

    Time frame: 6 weeks after embryo transfer

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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 17, 2012
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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