in Vitro MaturationNCT05600972
Non-FSH vs FSH-priming in Cycles With CAPA-IVM Treatment
A study testing FSH priming in people with in Vitro Maturation and FSH Priming, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
In vitro oocyte maturation (IVM) is an assisted reproductive technology requiring minimal or no ovarian stimulation. In this technique, the immature oocytes were retrieved from follicles and subsequently cultured matured, meaning that GV oocytes reached MII in vitro (ASRM, 2021). Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- in Vitro Maturation, FSH Priming
- What is being tested?
- FSH priming
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteVietnam
- Study dates
- 2 Jan 2023to 25 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Aging from 18 to 37
- Diagnosed with PCOS followed by Rotterdam criteria
- Having an indication for CAPA-IVM treatment
- Agree to have all embryos frozen on day 5/6.
- Agree to have one blastocyst (if of good quality defined as 3BB or above) or up to two blastocysts (if no good quality are available) transferred in a subsequent frozen transfer
- Having ≤ 2 IVM/IVF attempts
Who cannot join
- A previous ovarian stimulation (for OI or IVF) within the previous three months
- Cycles with oocytes donation
- Uterine or ovarian abnormalities
- Previous evidence of a very low oocyte maturation without suspicion of FSH /LH receptor defect
- Cycles with sperms retrieved after PESA/TESE/microTESE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficiency of Non-FSH Versus FSH-priming in CAPA-IVM Cycles: a Randomized Clinical Trial
In vitro oocyte maturation (IVM) is an assisted reproductive technology requiring minimal or no ovarian stimulation. In this technique, the immature oocytes were retrieved from follicles and subsequently cultured matured, meaning that GV oocytes reached MII in vitro (ASRM, 2021).
Currently, there is no consensus on the unique IVM protocol. However, recommended protocols that are being utilized include IVM with and without hCG (Standard IVM) and CAPA-IVM.
Read more
As mentioned previously, FSH priming before oocyte retrieval for IVM remains controversial. However, FSH is known as a hormone for the maturation of the follicles. Therefore, during oocyte maturation (IVM) cycles, FSH is used to "prime" follicular development. Generally, many studies showed a trend of a higher number of MII oocytes obtained after IVM after using FSH priming.
In animal models, Younis et al. (1994) observed a significant increase in the number of mature oocytes when performing IVM in cynomolgus monkeys (Macaca fascicularis) with a dose of 1000 IU of PMSG (pregnant mare's serum gonadotropin) in the follicular phase (Younis et al., 1994). Similarly, Wynn et al. (1998) conducted a study on mice. The results from this study revealed that a higher number of MII oocytes was observed. Still, the blastulation rate and the number of blastomeres were significantly lower than that without FSH priming. On the other hand, FSH activates meiosis resumption (Wynn et al., 1998).
In addition, an RCT of 28 patients comparing three days of 150 IU of FSH before the IVM aspiration group with the control group also showed an improvement in implantation rates in IVM cycles with FSH priming (Mikkelsen et al., 2001). The studies mentioned above both used the non-hCG IVM protocol. Other studies by Shalom-Paz et al. (2011) and Choavaratana et al. (2015) showed superiority in the number of MII oocytes.
There has been no data on the impact of not using FSH priming in CAPA-IVM cycles. Therefore, this RCT will investigate the efficacy of CAPA-IVM with and without FSH priming.
Read the detailed description
3.1. Screening for eligibility and randomization
- This trial will be conducted at My Duc Hospital, Ho Chi Minh City, Viet Nam.
- Women who are potentially eligible will be provided information about the trial at the time of IVM treatment indication.
- Screening for eligibility will be performed on the day of the first visit when the IVM treatment is indicated.
- Patients will be provided information related to the study together with the informed consent documents. Signed informed consent forms will be obtained by the investigators from all women before the enrolment.
- All patients selected for this study will undergo a 7-day COCPs administration to induce menstruation before entering both arms.
- Women will be randomized (1:1) to either non-FSH or FSH priming:
3.2 Oocytes retrieval The oocyte retrieval will be performed four days after the randomization, accordingly to the current routine procedures.
- An ultrasound scan will be performed to exclude the development of any dominant follicle.
- Patients randomized into the FSH priming arm will receive two days of FSH injections at 150 IU/day.
- Oocyte retrieval will be scheduled 42 hours after the last FSH injection.
- In the non-FSH arm, the COC will be retrieved on the same retrieval day as the FSH-treated arm.
- All the punctured follicular cohorts will be monitored carefully by ultrasound on the day before and on OPU day.
3.3 CAPA and Maturation culture: CAPA and Maturation culture will be performed routinely following current laboratory protocols.
- ICSI will be used for the fertilization of mature oocytes.
- The freeze-only will be performed, and all good embryos will be frozen on day 5 for subsequent embryo transfer.
3.4 Frozen embryo transfer After oocyte retrieval, a blister of oral contraceptive pills will be indicated to induce the bleeding.
Endometrial preparation with hormonal replacement therapy will be performed. In the following cycle, the endometrium will be prepared using oral estradiol valerate (Valiera®; Laboratories Recalcine) 8 mg/day starting from the second or third day of the menstrual cycle. The endometrial thickness will be monitored from day six onwards, and vaginal progesterone (Cyclogest®; Actavis) 800 mg/day will be started when endometrial thickness reached 7 mm or more. Elective single embryo transfer with a blastocyst will be performed. Embryos will be thawed on the day of embryo transfer, five days after the start of progesterone. Two hours after thawing, surviving embryos will be transferred into the uterus under ultrasound guidance. Embryos will be transferred into the uterine cavity.
3.5 Pregnancy test and ultrasound to confirm fetal viability: A pregnancy test will be performed by measuring the blood beta-hCG level two weeks after embryo transfer. If the pregnancy test is positive (≥25mIU/mL), the patient is indicated to use exogenous estrogen (transdermal or oral) and progesterone until at least 12 weeks of gestation. A pregnancy ultrasound will be performed three weeks after the positive pregnancy test equal to 7 weeks of gestational age.
3.6 Obstetric and neonatal outcomes: All data relating to the delivery process and neonatal care will be recorded by the data management system of IVFMD.
- Conditions
- in Vitro Maturation, FSH Priming
- Being tested
- FSH priming
- Keywords
- in vitro maturation, FSH priming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSH primingProcedure or surgery
Patients who are randomized into the FSH priming arm will receive two days of FSH injections of 150 IU/day. Oocyte retrieval will be scheduled at 42 hours after the last FSH injection.
| Study group | Role | What they receive |
|---|---|---|
| non-FSH priming | No intervention | Routine CAPA-IVM treatment will be performed. The oocyte retrieval will be performed 2 days after the randomization accordingly to the current routine procedures. An ultrasound scan will be performed to exclude the development of any dominant follicle. |
| FSH priming | Active comparator | Routine CAPA-IVM treatment will be performed. Patients who are randomized into the FSH priming arm will receive two days of FSH injections of 150 IU/day. Oocyte retrieval will be scheduled at 42 hours after the last FSH injection. Receives: Procedure: FSH priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of matured oocytes after CAPA-IVM cultured
Number of oocytes at MII stage after CAPA-IVM cultured
Measured: 2 day after oocyte retrieval
Secondary outcomes (18)
Positive pregnancy test rate
A positive pregnancy test is defined as a serum human chorionic gonadotropin level greater than 25 mIU/mL. The positive pregnancy test rate is the total positive pregnancy per the number of embryos transferred.
Measured: 2 weeks after embryo transfer
Implantation rate
Implantation rate is defined as the number of gestational sacs per the number of embryos transferred.
Measured: 3 weeks after embryo transfer
Ectopic pregnancy rate
Ectopic pregnancy is defined as pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology.
Measured: 4 weeks after embryo transfer
Clinical pregnancy rate
at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity
Measured: 5 weeks after embryo transfer
Ongoing pregnancy rate
Ongoing pregnancy is defined as pregnancy with a detectable heart rate at 12 weeks' gestation or beyond. The ongoing pregnancy rate is the total ongoing pregnancy per the number of embryos transferred.
Measured: 10 weeks after embryo transfer
Miscarriage rate
Miscarriage is defined as the spontaneous loss of an intra-uterine pregnancy prior to 12 completed weeks of gestational age).
Measured: 2-10 weeks after embryo transfer
Live birth rate
Defined as the complete expulsion or extraction from a woman of a product of fertilisation, after 24 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 350 grams or more can be used if gestational age is unknown (twins are a single count).
Measured: After delivery at 12 months after randomization
Multiple pregnancy rate
Multiple pregnancies are defined as the presence of more than one sac at early pregnancy ultrasound (6-8 weeks gestation).
Measured: 5 weeks after embryo transfer
Preterm delivery rate
Preterm delivery defined as delivery at <24, <28, <32, <37 completed weeks.
Measured: At delivery at 12 months after randomization
Birth weight
including low birth weight (defined as weight < 2500 gm at birth), very low birth weight (defined as < 1500 gm at birth), high birth weight (defined as >4000 gm at birth), and very high birth weight (defined as >4500 gm at birth).
Measured: At delivery at 12 months after randomization
Gestational diabetes mellitus
Using a 75g oral glucose tolerance test
Measured: At 24 weeks of gestation or beyond at 12 months after randomization
Hypertensive disorders of pregnancy
Pregnancy-induced hypertension, pre-eclampsia and eclampsia
Measured: At 20 weeks of gestation or beyond at 12 months after randomization
Antepartum hemorrhage
Including placenta previa, placenta accreta, and unexplained hemorrhage
Measured: After delivery at 12 months after randomization
Large for gestational age
Birth weight >90th centile for gestation, based on standardized ethnicity-based charts
Measured: After delivery at 12 months after randomization
Small for gestational age
Less than 10th centile for gestational age at delivery based on standardized ethnicity-based charts
Measured: After delivery at 12 months after randomization
Congenital anomaly
Any major congenital anomaly will be included
Measured: After delivery at 12 months after randomization
Perinatal mortality
The death of a fetus or infant from 24 weeks of gestation to the end of the neonatal period of 4 weeks after birth.
Measured: After delivery at 12 months after randomization
Admission to NICU
The admittance of the newborn to NICU
Measured: After delivery at 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start2 Jan 2023
- Primary completion10 Jul 2023
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for in Vitro MaturationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan N Vuong, M.D., Ph.D., Principal investigator, IVFMD and HOPE Research Center, My Duc Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600972
- Sponsor's protocol ID
- 13/22/DD-BVMD
- Status last verified
- Mar 2024
- First submitted
- 27 Oct 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vuong LN, Ho VNA, Le AH, Nguyen NT, Pham TD, Nguyen MHN, Le HL, Le TK, Ha AN, Le XTH, Pham HH, Tran CT, Huynh BG, Smitz JEJ, Gilchrist RB, Ho TM. Hormone-free vs. follicle-stimulating hormone-primed infertility treatment of women with polycystic ovary syndrome using biphasic in vitro maturation: a randomized controlled trial. Fertil Steril. 2025 Feb;123(2):253-261. doi: 10.1016/j.fertnstert.2024.09.010. Epub 2024 Sep 12.
PubMed 39260537
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 Efficiency of Non-FSH Versus FSH-priming in CAPA-IVM Cycles: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05600972
- Acronym / sponsor ID
- 13/22/DD-BVMD
- Conditions
- in Vitro Maturation, FSH Priming
- Keywords
- in vitro maturation, FSH priming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 1 Nov 2022 (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 oocyte maturation (IVM) is an assisted reproductive technology requiring minimal or no ovarian stimulation. In this technique, the immature oocytes were retrieved from follicles and subsequently cultured matured, meaning that GV oocytes reached MII in vitro (ASRM, 2021).
Currently, there is no consensus on the unique IVM protocol. However, recommended protocols that are being utilized include IVM with and without hCG (Standard IVM) and CAPA-IVM.
As mentioned previously, FSH priming before oocyte retrieval for IVM remains controversial. However, FSH is known as a hormone for the maturation of the follicles. Therefore, during oocyte maturation (IVM) cycles, FSH is used to "prime" follicular development. Generally, many studies showed a trend of a higher number of MII oocytes obtained after IVM after using FSH priming.
In animal models, Younis et al. (1994) observed a significant increase in the number of mature oocytes when performing IVM in cynomolgus monkeys (Macaca fascicularis) with a dose of 1000 IU of PMSG (pregnant mare's serum gonadotropin) in the follicular phase (Younis et al., 1994). Similarly, Wynn et al. (1998) conducted a study on mice. The results from this study revealed that a higher number of MII oocytes was observed. Still, the blastulation rate and the number of blastomeres were significantly lower than that without FSH priming. On the other hand, FSH activates meiosis resumption (Wynn et al., 1998).
In addition, an RCT of 28 patients comparing three days of 150 IU of FSH before the IVM aspiration group with the control group also showed an improvement in implantation rates in IVM cycles with FSH priming (Mikkelsen et al., 2001). The studies mentioned above both used the non-hCG IVM protocol. Other studies by Shalom-Paz et al. (2011) and Choavaratana et al. (2015) showed superiority in the number of MII oocytes.
There has been no data on the impact of not using FSH priming in CAPA-IVM cycles. Therefore, this RCT will investigate the efficacy of CAPA-IVM with and without FSH priming.
Detailed description
3.1. Screening for eligibility and randomization
- This trial will be conducted at My Duc Hospital, Ho Chi Minh City, Viet Nam.
- Women who are potentially eligible will be provided information about the trial at the time of IVM treatment indication.
- Screening for eligibility will be performed on the day of the first visit when the IVM treatment is indicated.
- Patients will be provided information related to the study together with the informed consent documents. Signed informed consent forms will be obtained by the investigators from all women before the enrolment.
- All patients selected for this study will undergo a 7-day COCPs administration to induce menstruation before entering both arms.
- Women will be randomized (1:1) to either non-FSH or FSH priming:
3.2 Oocytes retrieval The oocyte retrieval will be performed four days after the randomization, accordingly to the current routine procedures.
- An ultrasound scan will be performed to exclude the development of any dominant follicle.
- Patients randomized into the FSH priming arm will receive two days of FSH injections at 150 IU/day.
- Oocyte retrieval will be scheduled 42 hours after the last FSH injection.
- In the non-FSH arm, the COC will be retrieved on the same retrieval day as the FSH-treated arm.
- All the punctured follicular cohorts will be monitored carefully by ultrasound on the day before and on OPU day.
3.3 CAPA and Maturation culture: CAPA and Maturation culture will be performed routinely following current laboratory protocols.
- ICSI will be used for the fertilization of mature oocytes.
- The freeze-only will be performed, and all good embryos will be frozen on day 5 for subsequent embryo transfer.
3.4 Frozen embryo transfer After oocyte retrieval, a blister of oral contraceptive pills will be indicated to induce the bleeding.
Endometrial preparation with hormonal replacement therapy will be performed. In the following cycle, the endometrium will be prepared using oral estradiol valerate (Valiera®; Laboratories Recalcine) 8 mg/day starting from the second or third day of the menstrual cycle. The endometrial thickness will be monitored from day six onwards, and vaginal progesterone (Cyclogest®; Actavis) 800 mg/day will be started when endometrial thickness reached 7 mm or more. Elective single embryo transfer with a blastocyst will be performed. Embryos will be thawed on the day of embryo transfer, five days after the start of progesterone. Two hours after thawing, surviving embryos will be transferred into the uterus under ultrasound guidance. Embryos will be transferred into the uterine cavity.
3.5 Pregnancy test and ultrasound to confirm fetal viability: A pregnancy test will be performed by measuring the blood beta-hCG level two weeks after embryo transfer. If the pregnancy test is positive (≥25mIU/mL), the patient is indicated to use exogenous estrogen (transdermal or oral) and progesterone until at least 12 weeks of gestation. A pregnancy ultrasound will be performed three weeks after the positive pregnancy test equal to 7 weeks of gestational age.
3.6 Obstetric and neonatal outcomes: All data relating to the delivery process and neonatal care will be recorded by the data management system of IVFMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-FSH priming | No intervention | –Routine CAPA-IVM treatment will be performed. The oocyte retrieval will be performed 2 days after the randomization accordingly to the current routine procedures. An ultrasound scan will be performed to exclude the development of any dominant follicle. |
| FSH priming | Active comparator | Procedure: FSH primingRoutine CAPA-IVM treatment will be performed. Patients who are randomized into the FSH priming arm will receive two days of FSH injections of 150 IU/day. Oocyte retrieval will be scheduled at 42 hours after the last FSH injection. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aging from 18 to 37
- Diagnosed with PCOS followed by Rotterdam criteria
- Having an indication for CAPA-IVM treatment
- Agree to have all embryos frozen on day 5/6.
- Agree to have one blastocyst (if of good quality defined as 3BB or above) or up to two blastocysts (if no good quality are available) transferred in a subsequent frozen transfer
Key exclusion criteria (5 listed)
- A previous ovarian stimulation (for OI or IVF) within the previous three months
- Cycles with oocytes donation
- Uterine or ovarian abnormalities
- Previous evidence of a very low oocyte maturation without suspicion of FSH /LH receptor defect
- Cycles with sperms retrieved after PESA/TESE/microTESE
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 |
|---|---|---|
| FSH primingPatients who are randomized into the FSH priming arm will receive two days of FSH injections of 150 IU/day. Oocyte retrieval will be scheduled at 42 hours after the last FSH injection. | Procedure or surgery | FSH priming |
Primary outcome
Number of matured oocytes after CAPA-IVM cultured
Time frame: 2 day after oocyte retrieval
Number of oocytes at MII stage after CAPA-IVM cultured
18 secondary outcomes
Positive pregnancy test rate
Time frame: 2 weeks after embryo transfer
Implantation rate
Time frame: 3 weeks after embryo transfer
Ectopic pregnancy rate
Time frame: 4 weeks after embryo transfer
Clinical pregnancy rate
Time frame: 5 weeks after embryo transfer
Ongoing pregnancy rate
Time frame: 10 weeks after embryo transfer
Miscarriage rate
Time frame: 2-10 weeks after embryo transfer
Live birth rate
Time frame: After delivery at 12 months after randomization
Multiple pregnancy rate
Time frame: 5 weeks after embryo transfer
Preterm delivery rate
Time frame: At delivery at 12 months after randomization
Birth weight
Time frame: At delivery at 12 months after randomization
Gestational diabetes mellitus
Time frame: At 24 weeks of gestation or beyond at 12 months after randomization
Hypertensive disorders of pregnancy
Time frame: At 20 weeks of gestation or beyond at 12 months after randomization
Antepartum hemorrhage
Time frame: After delivery at 12 months after randomization
Large for gestational age
Time frame: After delivery at 12 months after randomization
Small for gestational age
Time frame: After delivery at 12 months after randomization
Congenital anomaly
Time frame: After delivery at 12 months after randomization
Perinatal mortality
Time frame: After delivery at 12 months after randomization
Admission to NICU
Time frame: After delivery at 12 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Derived from this study: PubMed 39260537Vuong LN, Ho VNA, Le AH, Nguyen NT, Pham TD, Nguyen MHN, Le HL, Le TK, Ha AN, Le XTH, Pham HH, Tran CT, Huynh BG, Smitz JEJ, Gilchrist RB, Ho TM. Hormone-free vs. follicle-stimulating hormone-primed infertility treatment of women with polycystic ovary syndrome using biphasic in vitro maturation: a randomized controlled trial. Fertil Steril. 2025 Feb;123(2):253-261. doi: 10.1016/j.fertnstert.2024.09.010. Epub 2024 Sep 12.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lan N Vuong, M.D., Ph.D. principal investigator
IVFMD and HOPE Research Center, My Duc Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FSH priming in people with in Vitro Maturation and FSH Priming, 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 6 inclusion and 5 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of matured oocytes after CAPA-IVM cultured (time frame: 2 day after oocyte retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05600972, which also lists 1 linked publication.
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.