Ovulatory Infertile WomenNCT06744881
CAPA - IVM in Ovulatory Infertile Women
A study testing CAPA-IVM in people with Ovulatory Infertile Women, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Ovulatory Infertile Women
- What is being tested?
- CAPA-IVM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Dec 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Ageing from 18 to 37.
- Women without PCOS:
- Having regular periods: >24 days and <35 days.
- And not having clinical hyperandrogenism or biochemical hyperandrogenism.
- And not presenting with peripheral distribution of polycystic ovaries on ultrasound.
- Antral follicle count 15 ≤AFC ≤ 24 and Anti-Mullerian Hormone 2,1 ≤ AMH ≤ 5 ng/mL)
Show all 12Show fewer
- Having indication for ART
- First ART cycle.
- No ovarian stimulation 3 months prior to study entry
- Agree to have all embryos frozen on day 3 or day 5.
- Agree to transfer no more than 02 cleavage-stage embryos or 01 blastocyst-stage embryo in a subsequent embryo transfer.
- Agree to participate in the study (Agree to undergo CAPA-IVM).
Who cannot join
- Donor oocyte cycles.
- Uterine abnormalities (adenomyosis, leiomyoma (≥5 cm), bicornuate uterus, intrauterine adhesion).
- Prior ovarian surgery.
- Surgically extracted sperm (by PESA, TESE or micro TESE).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
IVFMD - MyDuc Hospital
Ho Chi Minh City
Ho Long Le, MD, +84 356177147, bsho.ll@myduchospital.vn
About this study
Official title: The Effectiveness and Safety of CAPA - IVM in Ovulatory Infertile Women: a Pilot Study
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).
Read more
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.
Read the detailed description
- Screening for eligibility and randomization
- This trial will be conducted at My Duc Hospital, Ho Chi Minh City, Viet Nam.
- Eligibility screening will be performed on the first visit.
- Patients meeting the inclusion criteria will be invited to participate in the study. Patients will be provided with study information and consent forms. The investigator will collect signed consent forms from all participants.
- Oocyte retrieval: 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.
- Capacitation in vitro maturation The follicular aspirates are collected and filtered through a cell strainer. After collection, COCs are washed and transferred to a four-well dish, containing CAPA medium. Following 24 hours of incubation in CAPA media, COCs complexes are cultured in IVM medium for 30 hours. Following IVM culture, oocytes are mechanically and enzymatically denuded from their cumulus layers under a stereomicroscope and oocyte maturation is assessed under the inverted microscope
- Fertilization:
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.
- Conditions
- Ovulatory Infertile Women
- Being tested
- CAPA-IVM
- Keywords
- CAPA-IVM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPA-IVMProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| To evaluate the effectiveness and safety of CAPA-IVM in ovulatory infertile women in relation to the | Experimental | Not described Receives: Procedure: CAPA-IVM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of metaphase II oocytes available after CAPA-IVM culture
This will be analyzed according to the patient's ovarian reserve
Measured: 24-48 hours after eggs retrieved
Secondary outcomes (14)
Number of patients aspirated without oocytes
Count the number of patients aspirated without oocytes
Measured: OR day
Number of patients without mature oocytes after CAPA-IVM
Count the number of patients without mature oocytes
Measured: OR day
Number of patients without embryos
Count the number of patients without embryos
Measured: OR day
Oocyte maturation rate
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
Measured: 24-48 hours after eggs retrieval.
Fertilization rate
Number of fertilized oocytes divided by the number of ICSI oocytes
Measured: ICSI day
Number of fertilized oocytes
Count the number of 2PN oocytes at 16-18 hours after ICSI
Measured: 16-18 hours after ICSI
Number of day-3 embryos
Count the number of day-3 embryos at 64±2 hours after ICSI
Measured: 64±2 hours after ICSI
Day-3 embryo rate
Number of day-3 embryos divided by the number of fertilized oocytes
Measured: 64±2 hours after ICSI
Number of good quality day-3 embryos
Count the number of day-3 embryos graded as grade 1 and grade 2.
Measured: 64±2 hours after ICSI
Number of day-3 embryos frozen
Count the number of day-3 embryos frozen
Measured: 64±2 hours after ICSI
Number of day-5/6 embryos
Count the number of day-5 embryos at 114±2/140±2 after ICSI
Measured: 114±2/140±2 after ICSI
Day-5/6 embryo rate
Number of day-5/6 embryos divided by the number of fertilized oocytes
Measured: 114±2/140±2 after ICSI
Number of good quality day-5/6 embryos
Count the number of day-5/6 embryos graded as grade 1 and grade 2
Measured: 114±2/140±2 after ICSI
Number of day-5/6 embryos frozen
Count the number of day-5/6 embryos frozen
Measured: 114±2/140±2 after ICSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovulatory Infertile WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A pilot study (in blocks of 5 participants per cohort and 4 cohorts in total)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744881
- Sponsor's protocol ID
- 11/24/DD-BVMD
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of CAPA - IVM in Ovulatory Infertile Women: a Pilot Study
- ClinicalTrials.gov ID
- NCT06744881
- Acronym / sponsor ID
- 11/24/DD-BVMD
- Conditions
- Ovulatory Infertile Women
- Keywords
- CAPA-IVM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Screening for eligibility and randomization
- This trial will be conducted at My Duc Hospital, Ho Chi Minh City, Viet Nam.
- Eligibility screening will be performed on the first visit.
- Patients meeting the inclusion criteria will be invited to participate in the study. Patients will be provided with study information and consent forms. The investigator will collect signed consent forms from all participants.
- Oocyte retrieval: 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.
- Capacitation in vitro maturation The follicular aspirates are collected and filtered through a cell strainer. After collection, COCs are washed and transferred to a four-well dish, containing CAPA medium. Following 24 hours of incubation in CAPA media, COCs complexes are cultured in IVM medium for 30 hours. Following IVM culture, oocytes are mechanically and enzymatically denuded from their cumulus layers under a stereomicroscope and oocyte maturation is assessed under the inverted microscope
- Fertilization:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pilot study (in blocks of 5 participants per cohort and 4 cohorts in total)
| Arm | Type | Receives |
|---|---|---|
| To evaluate the effectiveness and safety of CAPA-IVM in ovulatory infertile women in relation to the | Experimental | Procedure: CAPA-IVM |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Ageing from 18 to 37.
- Women without PCOS:
- Having indication for ART
- First ART cycle.
- No ovarian stimulation 3 months prior to study entry
Key exclusion criteria (4 listed)
- Donor oocyte cycles.
- Uterine abnormalities (adenomyosis, leiomyoma (≥5 cm), bicornuate uterus, intrauterine adhesion).
- Prior ovarian surgery.
- Surgically extracted sperm (by PESA, TESE or micro TESE).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPA-IVMOn 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 | Procedure or surgery | To evaluate the effectiveness and safety of CAPA-IVM in ovulatory infertile women in relation to the |
Primary outcome
Number of metaphase II oocytes available after CAPA-IVM culture
Time frame: 24-48 hours after eggs retrieved
This will be analyzed according to the patient's ovarian reserve
14 secondary outcomes
Number of patients aspirated without oocytes
Time frame: OR day
Number of patients without mature oocytes after CAPA-IVM
Time frame: OR day
Number of patients without embryos
Time frame: OR day
Oocyte maturation rate
Time frame: 24-48 hours after eggs retrieval.
Fertilization rate
Time frame: ICSI day
Number of fertilized oocytes
Time frame: 16-18 hours after ICSI
Number of day-3 embryos
Time frame: 64±2 hours after ICSI
Day-3 embryo rate
Time frame: 64±2 hours after ICSI
Number of good quality day-3 embryos
Time frame: 64±2 hours after ICSI
Number of day-3 embryos frozen
Time frame: 64±2 hours after ICSI
Number of day-5/6 embryos
Time frame: 114±2/140±2 after ICSI
Day-5/6 embryo rate
Time frame: 114±2/140±2 after ICSI
Number of good quality day-5/6 embryos
Time frame: 114±2/140±2 after ICSI
Number of day-5/6 embryos frozen
Time frame: 114±2/140±2 after ICSI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPA-IVM in people with Ovulatory Infertile Women, run by Mỹ Đức Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ho Long Le, MD (+84 356177147, bsho.ll@myduchospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of metaphase II oocytes available after CAPA-IVM culture (time frame: 24-48 hours after eggs retrieved). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.