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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]

nil

Universal Trial Number (UTN)

Trial acronym

The MINIVA Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

infertility

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

Clinical pregnancy rate as determined by viable fetal heart beat

Timepoint [1]

8 weeks gestation

Secondary outcome [1]

Fertilisation rates as assessed by embryologists confirming the presence of 2 pronuclei under microscopic review

Timepoint [1]

day+ 1 post oocyte collection

Secondary outcome [2]

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]

day +3 post oocyte collection

Secondary outcome [3]

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]

day +4 post oocyte collection

Secondary outcome [4]

Embryo utilisation rates (% of embryos that are frozen or transferred)

Timepoint [4]

day of embryo transfer

Secondary outcome [5]

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]

after all embryos from fresh cycle have been utilised

Secondary outcome [6]

quantatative hCG level using serum hCG assay

Timepoint [6]

day + 16 - 19 post oocyte collection

Secondary outcome [7]

Number of cancelled cycles

Timepoint [7]

day +16 - 19 post occyte collection

Secondary outcome [8]

Number of frozen embryos

Timepoint [8]

day of embryo transfer

Secondary outcome [9]

Pain tolerance for local anesthetic using a visual analogue scale for pain recording

Timepoint [9]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Australia

Primary sponsor type

Other

Name

Adelaide Fertility Centre Pty Ltd

Address

180 Fullarton Road
Dulwich SA 5065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network HREC

Ethics committee address [1]

Women's and Children's Hospital
72 Kermode St
North Adelaide SA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/05/2012

Ethics approval number [1]

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

Dr Dr Michelle LAne

Address

Repromed
180 Fullarton Road
Dulwich South Australia 5065

Country

Australia

Phone

+61 8 83338111

Fax

[email protected]

Contact person for public queries

Name

Helen Alvino

Address

180 Fullarton Road
Dulwich SA 5065

Country

Australia

Phone

+61 (0) 8 83338111

Fax

+61 (0) 8 83338811

[email protected]

Contact person for scientific queries

Name

Dr Deirdre Zander Fox

Address

180 Fullarton Road
Dulwich SA 5065

Country

Australia

Phone

+61 (0) 8 83338111

Fax

+61 (0) 8 83338811

[email protected]

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

Source	Title	Year of Publication	DOI
Embase	Sequential clomiphene/corifollitrophin alpha as a technique for mild controlled ovarian hyperstimulation in IVF: a proof of concept study.	2018	https://dx.doi.org/10.1007/s10815-018-1172-y

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically