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

NCT01667406 | Completed Phase 2 Results DMC

• 2 other identifiers: 13HH01992012-000154-61
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Keywords

kisspeptin; infertility; in vitro fertilisation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Biochemical Pregnancy

  11 days after embryo transfer

• Occurrence of OHSS

  11 days following embryo transfer

• Fertilization Rate

  3 days after oocyte retrieval

• Embryo Formation

  3 days after oocyte retrieval

• Number of Participants With Clinical Pregnancy

  6 weeks after embryo transfer

Study Arms (10)

Kisspeptin-54, 1.6 single

EXPERIMENTAL

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

Drug: Kisspeptin 1.6nmol/kg

Kisspeptin-54, 3.2 single

EXPERIMENTAL

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

Drug: Kisspeptin 3.2nmol/kg

Kisspeptin-54, 6.4 single

EXPERIMENTAL

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

Drug: Kisspeptin 6.4nmol/kg

Kisspeptin-54, 12.8 single

EXPERIMENTAL

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

Drug: Kisspeptin 12.8nmol/kg

Kisspeptin-54 OHSS, 3.2 single

EXPERIMENTAL

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

Drug: Kisspeptin 3.2nmol/kg

Kisspeptin-54 OHSS, 6.4 single

EXPERIMENTAL

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

Drug: Kisspeptin 6.4nmol/kg

Kisspeptin-54 OHSS, 9.6 single

EXPERIMENTAL

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

Drug: Kisspeptin 9.6nmol/kg

Kisspeptin-54 OHSS, 12.8 single

EXPERIMENTAL

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

Drug: Kisspeptin 12.8nmol/kg

Kisspeptin-54 OHSS, 9.6 + 9.6

EXPERIMENTAL

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

Drug: Kisspeptin 9.6 nmol/kg double

Kisspeptin-54 OHSS, 9.6 + saline

EXPERIMENTAL

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

Drug: Kisspeptin 9.6 nmol/kg + saline

Interventions

Kisspeptin 1.6nmol/kg DRUG

single kisspeptin dose 1.6 nmol/kg subcutaneously

Also known as: kisspeptin-54

Kisspeptin-54, 1.6 single

Kisspeptin 3.2nmol/kg DRUG

single kisspeptin dose 3.2 nmol/kg subcutaneously

Also known as: kisspeptin-54

Kisspeptin-54 OHSS, 3.2 single; Kisspeptin-54, 3.2 single

Kisspeptin 6.4nmol/kg DRUG

single kisspeptin dose 6.4 nmol/kg subcutaneously

Also known as: kisspeptin-54

Kisspeptin-54 OHSS, 6.4 single; Kisspeptin-54, 6.4 single

Kisspeptin 9.6nmol/kg DRUG

single kisspeptin dose 9.6 nmol/kg subcutaneously

Also known as: kisspeptin-54

Kisspeptin-54 OHSS, 9.6 single

Kisspeptin 12.8nmol/kg DRUG

single kisspeptin dose 12.8 nmol/kg subcutaneously

Also known as: kisspeptin-54

Kisspeptin-54 OHSS, 12.8 single; Kisspeptin-54, 12.8 single

Kisspeptin 9.6 nmol/kg double DRUG

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

Also known as: kisspeptin-54

Kisspeptin-54 OHSS, 9.6 + 9.6

Kisspeptin 9.6 nmol/kg + saline DRUG

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

Also known as: kisspeptin-54

Kisspeptin-54 OHSS, 9.6 + saline

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: woman undergoing IVF treatment
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital

London, W12 0NN, United Kingdom

Location

Related Publications (5)

• 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 vitro fertilization. J Clin Invest. 2014 Aug;124(8):3667-77. doi: 10.1172/JCI75730. Epub 2014 Jul 18.

  PMID: 25036713 RESULT

• 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 improves oocyte maturation in women at high risk of ovarian hyperstimulation syndrome: a Phase 2 randomized controlled trial. Hum Reprod. 2017 Sep 1;32(9):1915-1924. doi: 10.1093/humrep/dex253.

  PMID: 28854728 RESULT

• 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 Oocyte Maturation in Women at High Risk of Ovarian Hyperstimulation Syndrome (OHSS) During In Vitro Fertilization (IVF) Therapy. J Clin Endocrinol Metab. 2015 Sep;100(9):3322-31. doi: 10.1210/jc.2015-2332. Epub 2015 Jul 20.

  PMID: 26192876 RESULT

• Abbara A, Islam R, Clarke SA, Jeffers L, Christopoulos G, Comninos AN, Salim R, Lavery SA, Vuong TNL, Humaidan P, Kelsey TW, Trew GH, Dhillo WS. Clinical parameters of ovarian hyperstimulation syndrome following different hormonal triggers of oocyte maturation in IVF treatment. Clin Endocrinol (Oxf). 2018 Jun;88(6):920-927. doi: 10.1111/cen.13569. Epub 2018 Mar 6.

  PMID: 29446481 DERIVED

• Owens LA, Abbara A, Lerner A, O'floinn S, Christopoulos G, Khanjani S, Islam R, Hardy K, Hanyaloglu AC, Lavery SA, Dhillo WS, Franks S. The direct and indirect effects of kisspeptin-54 on granulosa lutein cell function. Hum Reprod. 2018 Feb 1;33(2):292-302. doi: 10.1093/humrep/dex357.

  PMID: 29206944 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Kisspeptins; Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Neuropeptides; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Professor Waljit Dhillo
• Organization: Imperial College London

w.dhillo@imperial.ac.uk

442083833242

Study Officials

• Waljit S Dhillo, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: participants and IVF physicians were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Different dose for each volunteer

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 17, 2012
• Study Start: June 1, 2012
• Primary Completion: October 11, 2016
• Study Completion: October 11, 2016
• Last Updated: June 8, 2021
• Results First Posted: June 8, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)