IVFMD - MyDuc Hospital
Ho Chi Minh City, Vietnam
NCT Number: NCT06744881
In vitro maturation (IVM) is an assisted reproductive technology (ART) using minimal or no ovarian stimulation. In IVM, immature oocytes at the germinal vesical (GV) or metaphase I (MI) stage retrieved from small antral follicles are cultured to reach metaphase II (MII) (ASRM, 2021).
Since the first successful IVM baby was reported, subsequent studies have been mostly focused on patients with polycystic ovary syndrome (PCOS) to reduce the risks associated with ovarian stimulation such as ovarian hyperstimulation syndrome (OHSS), thromboembolic complications and ovarian torsion (Cha et al., 1991; Chian et al., 2000). Numerous IVM protocols have been applied with or without FSH or hCG priming and using one step or two steps culture system to gain the optimum oocyte maturation rate, blastulation rate and live birth rate (Sanchez et al., 2019; De Vos et al., 2021).
A randomized controlled trial (RCT) conducted on women with high antral follicle count, including women with PCOS, indicated that CAPA-IVM was non-inferior to conventional IVF (Vuong et al., 2020). Studies also showed that the mental and motor development of children born after IVM was similar to that of those born after IVF and naturally conceived (Nguyen et al., 2022; Vuong et al., 2022). Additionally, IVM is considered an effective treatment for women with gonadotropin resistant ovary syndrome to have children with their own oocytes (Le et al., 2021). IVM is also a viable option for fertility preservation for women with cancer in need of urgent treatment and contraindicated to hormonal stimulation (Grynberg et al., 2022).
There is little evidence on the effectiveness of IVM on women without PCOS. Junk et al have compared the effectiveness of IVM between women with polycystic ovaries (PCO) and polycystic ovary syndrome (Junk and Yeap, 2012). Women with PCO had significantly lower oocytes collected than those with PCOS (p<0,001), maturation rate, blastocyst development rate, and clinical pregnancy rate were comparable between two groups (Junk and Yeap, 2012). Another study indicated the maturation rate after standard IVM of ovarian tissue-derived oocytes collected from cancer patients was 8-67% (Segers et al., 2020). A study conducted by Kirillova on ovarian cancer patients with normal to high ovarian reserve showed that CAPA-IVM resulted in a higher maturation rate in ovarian tissue oocytes compared to standard IVM (56% vs 36%, p=0.0045) (Kirillova et al., 2021).
Recently, IVF/ICSI has been indicated in almost all infertility patients without PCOS. A randomized controlled trial on non-PCOS women with high antral follicle counts revealed no significant differences between IVM and conventional IVF regarding the ongoing pregnancy rate, live birth rate and the incidence of pregnancy and perinatal complications (Vuong et al., 2020). IVM offers numerous advantages due to the concept of using mild or no stimulation. The risk of ovarian hyperstimulation syndrome is largely eliminated, the cost of treatment is notably reduced. IVM is also more convenient as it requires fewer patient visits, ultrasounds and blood tests (Ho and Vuong, 2023).
Therefore, this pilot study is to evaluate the effectiveness and safety of CAPA-IVM in ovulatory infertile women and evaluate its success rate in relation to their ovarian reserve.
Trial opening soon.
Get Notified18 year–37 year
Female
Interventional
Not applicable
Ho Chi Minh City, Vietnam
On days 2-4 of the menstrual cycle, after patients have consented to CAPA-IVM, they will undergo oocyte aspiration anytime thereafter but no later than day 6 of the cycle.
Cycle programming with oral contraceptives or progestogens, nor ovarian stimulation with rFSH or hMG preparations nor the use GnRH analogues are allowed. The use of oral contraceptives will be considered from the second cohort of patients onwards in case the timing/scheduling of the oocyte retrieval needs to be optimized. No hCG or GnRH agonist preparations will be administered for triggering ovarian maturation prior to oocyte retrieval.
ICSI will be used to fertilize mature oocytes. Embryos will be cryopreserved at the cleavage-stage embryo (day 3) if the patient has less than 4 embryos. Patients with 4 or more embryos will be counseled on blastocyst culture (day 5) according to the IVFMD protocol. All viable embryos will be cryopreserved.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
On days 2-4 of the menstrual cycle, after patients have consented to CAPA-IVM, they will undergo oocyte aspiration anytime thereafter but no later than day 6 of the cycle. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Freeze-only on day 3 or day 5 and frozen embryo transfer will be performed on the subsequent cycle using HRT protocol with a maximum of 2 embryos transfer
Time frame: 24-48 hours after eggs retrieved
This will be analyzed according to the patient's ovarian reserve
Time frame: OR day
Count the number of patients aspirated without oocytes
Time frame: OR day
Count the number of patients without mature oocytes
Time frame: OR day
Count the number of patients without embryos
Time frame: 24-48 hours after eggs retrieval.
The oocyte maturation rate is calculated by dividing the number of MII oocytes after CAPA-IVM by the number of cumulus-oocyte complex (COC) retrieved
Time frame: ICSI day
Number of fertilized oocytes divided by the number of ICSI oocytes
Time frame: 16-18 hours after ICSI
Count the number of 2PN oocytes at 16-18 hours after ICSI
Time frame: 64±2 hours after ICSI
Count the number of day-3 embryos at 64±2 hours after ICSI
Time frame: 64±2 hours after ICSI
Number of day-3 embryos divided by the number of fertilized oocytes
Time frame: 64±2 hours after ICSI
Count the number of day-3 embryos graded as grade 1 and grade 2.
Time frame: 64±2 hours after ICSI
Count the number of day-3 embryos frozen
Time frame: 114±2/140±2 after ICSI
Count the number of day-5 embryos at 114±2/140±2 after ICSI
Time frame: 114±2/140±2 after ICSI
Number of day-5/6 embryos divided by the number of fertilized oocytes
Time frame: 114±2/140±2 after ICSI
Count the number of day-5/6 embryos graded as grade 1 and grade 2
Time frame: 114±2/140±2 after ICSI
Count the number of day-5/6 embryos frozen
Contact information is provided by the study sponsor or research team.
Mỹ Đức Hospital
Other
The Effectiveness and Safety of CAPA - IVM in Ovulatory Infertile Women: a Pilot Study
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