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A pilot study to assess low dose ovarian stimulation using local anaesthetic to collect oocytes for women having IVF treatment

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.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000740897
Acronym
The MINIVA Study
Enrollment
20
Registered
2012-07-11
Start date
2012-07-13
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Adelaide Fertility Centre Pty Ltd
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 38 Years
Healthy volunteers
No

Inclusion criteria

Female Partner *Normal ovarian reserve *BMI <35 kg/m2 *Normal ovulatory cycles Male Partner Normal semen analysis as per WHO parameters

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 7, 2026