Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000740897
Ethics application status
Approved
Date submitted
15/06/2012
Date registered
11/07/2012
Date last updated
1/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to assess low dose ovarian stimulation using local anaesthetic to collect oocytes for women having IVF treatment
Scientific title
A pilot study to assess the clinical pregnancy rate following low dose minimal ovarian stimulation with the oocyte retrieval under local anaesthetic for women undergoing IVF/ICSI treatment compared to case matched controls.
Secondary ID [1] 280682 0
nil
Universal Trial Number (UTN)
Trial acronym
The MINIVA Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertility 286710 0
Condition category
Condition code
Reproductive Health and Childbirth 287006 287006 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
participants will be on oral contraceptive pill prior to IVF cycle commencement.
Clomiphene citrate 100mgs will be administered orally day 2 to 5 of the menstrual cycle. On day 6 of the cycle a single sub cutaneous injection of Corifollitropin alfa150mg will be given and from day 7 of cycle daily sub cutaneous injections of Ganirelix 250 mg, until > 2 follicle measure 17mm when a sub cutaneous injection of Choriogonadotropin alfa 250mgm will be administered prior to oocyte collection 36 hours later. To collect oocytes under local anaesthetic, preoperative paracetamol 1g given rectally, preovarian block, 10ml lidocaine 1% injected under ultrasound guidance into vaginal wall either side of cervix. fentanyl 50 - 100mcg administered intravenously immediately prior to ovarian aspiration.
Intervention code [1] 285091 0
Treatment: Drugs
Comparator / control treatment
case matched controls will be women undergoing IVF using standard ovarian stimulation protocols at the same time as the study participants. Standard ovarian stimulation protocols will be based on women's age, BMI and previous response to ovarian stimullation,
Control group
Active

Outcomes
Primary outcome [1] 287340 0
Clinical pregnancy rate as determined by viable fetal heart beat
Timepoint [1] 287340 0
8 weeks gestation
Secondary outcome [1] 297938 0
Fertilisation rates as assessed by embryologists confirming the presence of 2 pronuclei under microscopic review
Timepoint [1] 297938 0
day+ 1 post oocyte collection
Secondary outcome [2] 297939 0
Embryo quality on Day 3. Will be assessed by embryologists reviewing the embryo for number of cells, shape of cells, presence of multinucleation, presence of fragmentation under microscopic review.
Timepoint [2] 297939 0
day +3 post oocyte collection
Secondary outcome [3] 297940 0
Embryo quality on Day 4.Will be assessed by embryologists reviewing the embryo for number of cells, shape of cells, presence of multinucleation, presence of fragmentation under microscopic review.
Timepoint [3] 297940 0
day +4 post oocyte collection
Secondary outcome [4] 297941 0
Embryo utilisation rates (% of embryos that are frozen or transferred)
Timepoint [4] 297941 0
day of embryo transfer
Secondary outcome [5] 297942 0
Cumulative pregnancy rates (fresh & frozen) as dertermined by presence of gestational sac or fetal heartbeat seen on ultrasound 3 to 4 weeks after ovulation.
Timepoint [5] 297942 0
after all embryos from fresh cycle have been utilised
Secondary outcome [6] 297943 0
quantatative hCG level using serum hCG assay
Timepoint [6] 297943 0
day + 16 - 19 post oocyte collection
Secondary outcome [7] 297944 0
Number of cancelled cycles
Timepoint [7] 297944 0
day +16 - 19 post occyte collection
Secondary outcome [8] 297945 0
Number of frozen embryos
Timepoint [8] 297945 0
day of embryo transfer
Secondary outcome [9] 297946 0
Pain tolerance for local anesthetic using a visual analogue scale for pain recording
Timepoint [9] 297946 0
day of Oocyte collection and 24 hours post oocyte collection

Eligibility
Key inclusion criteria
Female Partner
*Normal ovarian reserve
*BMI <35 kg/m2
*Normal ovulatory cycles

Male Partner
Normal semen analysis as per WHO parameters
Minimum age
18 Years
Maximum age
38 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Couples using donor gametes
Low ovarian reserve (AMH <14 pmol/l or AFC <5)
High ovarian reserve (AMH >30 pmol/l or AFC >20)
Women with a diagnosis of polycystic ovarian syndrome (PCOS)
Patients who need general anaesthetic for oocyte collection
Patients with history of drug sensitivity or allergic reaction to lignocaine
Abnormal position of ovaries
Preimplantation genetic diagnosis
Male partner who requires surgical sperm collection

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285443 0
Self funded/Unfunded
Name [1] 285443 0
Country [1] 285443 0
Australia
Primary sponsor type
Other
Name
Adelaide Fertility Centre Pty Ltd
Address
180 Fullarton Road
Dulwich SA 5065
Country
Australia
Secondary sponsor category [1] 284294 0
None
Name [1] 284294 0
Address [1] 284294 0
Country [1] 284294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287457 0
Women's and Children's Health Network HREC
Ethics committee address [1] 287457 0
Women's and Children's Hospital
72 Kermode St
North Adelaide SA 5006
Ethics committee country [1] 287457 0
Australia
Date submitted for ethics approval [1] 287457 0
Approval date [1] 287457 0
01/05/2012
Ethics approval number [1] 287457 0
14/12/2428

Summary
Brief summary
In the last 5-10 years there have been major advances in the technology and knowledge of assisited reproductive technology treatments. These include improved media and control of the environment for culturing human embryos. As a result there have been significant improvements in pregnancy rates and a significant increase in the transfer of a single embryo, to prevent the complications associated with multiple pregnancy. Historically, pregnancy rates have increased with greater numbers of eggs collected. Therefore superovulation procedures designed to enable the collection of 10-15 eggs per IVF cycle were a required part of the treatment strategy. However, with the recent advances of improved embryology techniques and pregnancy rates the requirement for a large number of eggs to be collected from young women has reduced. Modelling from our own laboratory has shown that pregnancy rates in young women plateau at 3-4 eggs. Therefore in this group of women production of more than four eggs in a stimulated cycle does not increase pregnancy rates but are associated with the risk of complications such as ovarian hyperstimulation syndrome (OHSS) (Reviewed in Verberg et al., 2009). Futhermore, there is increasing evidence in both animal models and also in the human that there are increased benefits of low dose stimulation. High doses of stimulation are associated with increased rates of poor quality oocytes and embryos (Valbuena et al., 2001) and have been reported to affect endometrial competence as well as reportedly increasing the incidence of aneuploidy (Baart et al. 2007). As a result of this new information, there has been the development of a more physiological style of ovarian stimulation in IVF for good prognosis patients, involving very low dose stimulation coupled with high quality embryology. These protocols are designed to produce a small number of eggs (aim 3-4 eggs) which can be fertilised, cultured and the best embryo transferred. As the literature presents such diverse findings we are initiating a pilot case-matched study to establish the efficacy of and patient feedback of tolerance to minimal stimulation regimes in an IVF cycle. Therefore, this pilot study is designed to assess the outcome of a low dose minimal stimulation treatment regime in a selected group of women undergoing IVF treatment.An interim analysis will be conducted after 10 cycles and if significant problems are identified, or average oocyte retrieval rates are below 2 eggs, the study will be abandoned at that point.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34319 0
Dr Dr Michelle LAne
Address 34319 0
Repromed
180 Fullarton Road
Dulwich South Australia 5065
Country 34319 0
Australia
Phone 34319 0
+61 8 83338111
Fax 34319 0
Email 34319 0
mlane@repromed.com.au
Contact person for public queries
Name 17566 0
Ms Helen Alvino
Address 17566 0
180 Fullarton Road
Dulwich SA 5065
Country 17566 0
Australia
Phone 17566 0
+61 (0) 8 83338111
Fax 17566 0
+61 (0) 8 83338811
Email 17566 0
halvino@repromed.com.au
Contact person for scientific queries
Name 8494 0
Dr Dr Deirdre Zander Fox
Address 8494 0
180 Fullarton Road
Dulwich SA 5065
Country 8494 0
Australia
Phone 8494 0
+61 (0) 8 83338111
Fax 8494 0
+61 (0) 8 83338811
Email 8494 0
dzander@repromed.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSequential clomiphene/corifollitrophin alpha as a technique for mild controlled ovarian hyperstimulation in IVF: a proof of concept study.2018https://dx.doi.org/10.1007/s10815-018-1172-y
N.B. These documents automatically identified may not have been verified by the study sponsor.