Diminished Ovarian Reserve (DOR)MSCPDNCT07568639
Multi-Site Cortical Puncture for DOR
A study testing multiple ovarian cortex punctures and routine oocyte retrieval procedure in people with Diminished Ovarian Reserve (DOR), run by First Affiliated Hospital of Guangxi Medical University at 7 sites in China.
Trial summary
A multicenter, prospective, randomized controlled clinical trial. The target population consists of patients undergoing IVF/ICSI artificial reproduction who plan to undergo ovarian stimulation and embryo retrieval (DOR) within 4 months. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve (DOR)
- What is being tested?
- multiple ovarian cortex punctures and routine oocyte retrieval procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 7 sitesChina
- Study dates
- 30 Apr 2026to 30 Dec 2030
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-45 years;
- Infertile women meeting the diagnostic criteria for diminished ovarian reserve (DOR); The following two criteria must be met simultaneously: ① Anti-Müllerian hormone (AMH) ≤0.5 ng/ml, ② Bilateral ovarian antral follicles (AFC) ≤5 (3-9 mm).
- Patients scheduled for IVF (in vitro fertilization)/ICSI (intracytoplasmic sperm injection) treatment;
- Patients who plan for whole embryo cryopreservation and intend to undergo another ovulation induction cycle within 4 natural months starting from the first cycle, with the goal of embryo retrieval and embryo banking;
- Bilateral follicles were observed during AFC examination;
- The planned ovarian stimulation protocol is one of PPOS, antagonist, or microstimulation protocols;
- The first ovulation induction protocol is planned to be consistent with the second ovulation induction protocol;
- Voluntary participation in the study and signing of the informed consent form.
Who cannot join
- Patients with the following reproductive and gynecological comorbidities: history of salpingectomy, ovarian cysts (e.g., chocolate cysts), ovarian tumors, or simple cysts ≥10 mm (not eligible for enrollment in the current cycle; may be enrolled after regression), history of ovarian surgery, endometriosis or adenomyosis, or acute pelvic inflammatory disease;
- Patients with abnormal ovarian position who are expected to experience difficulties during oocyte retrieval puncture;
- Patients with concomitant systemic severe diseases (history of severe chronic diseases such as heart failure, myocardial infarction, stroke, end-stage renal disease; advanced cancer or other terminal illnesses with an estimated survival period of less than 6 months; coagulation disorders; uncontrolled sepsis; autoimmune diseases; poor general condition rendering anesthesia and surgery intolerable);
- Patients with contraindications to hormone replacement therapy;
- Currently undergoing treatment with cytotoxic drugs, glucocorticoids or other immunosuppressants, radiotherapy or chemotherapy, or having previously received radiotherapy or chemotherapy;
- One spouse has chromosomal abnormalities;
Show all 9Show fewer
- Patients with a history of uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders, where the investigator determines that clinical severity affects compliance with the clinical study;
- Patients who have undergone oocyte retrieval or ovarian puncture within the past year;
- Participating in other clinical trials.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
Guigang City People's Hospital
Guigang, Guangxi
Ting Liang, 86-0775-4200316, 233134713@qq.com
Liuzhou People's Hospital
Liuzhou, Guangxi
Xiaoli Qu, 86-0772-3612345, LRYqxl123@163.com
Nanning Maternity and Child Health Care Hospital
Nanning, Guangxi, 530011
Wenhong Ma, 86-0771-2860963, 1716366453@qq.com
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
hua Yi Yang, 86-0771-5356126, workyyh@163.com
The Second Nanning People's Hospital
Nanning, Guangxi
Rong Li, 86-0771-4808011, lirong@sr.gxmu.edu.cn
Qinzhou Maternity and Child Health Care Hospital
Qinzhou, Guangxi
Hongbo Wu, 86-13517813505, wuhongbo20212021@163.com
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Youzhu Li, 86-0592-2137327, LYZART@xmu.edu.cn
About this study
Official title: Clinical Efficacy and Safety of Multiple Ovarian Cortex Punctures in Improving Ovarian Reserve and Ovarian Stimulation Outcomes in Patients With Diminished Ovarian Reserve (DOR): A Multicenter, Prospective, Randomized Controlled Clinical Trial
A multicenter, prospective, randomized controlled clinical trial. The target population consists of patients undergoing IVF/ICSI artificial reproduction who plan to undergo ovarian stimulation and embryo retrieval (DOR) within 4 months. A stratified block randomization method was employed to assign participants in a 1:1 ratio to the intervention group and control group. The study aims to investigate whether multiple-point ovarian cortex puncture during the initial oocyte retrieval procedure improves ovarian reserve and ovarian stimulation outcomes in DOR patients compared to conventional oocyte retrieval techniques.
Read the detailed description
This is a multicenter, prospective, randomized controlled clinical trial designed to evaluate the efficacy of ovarian cortex multi-point puncture in improving ovarian reserve and ovarian stimulation outcomes in patients with delayed ovarian reserve (DOR). The target population consists of DOR patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) with plans for subsequent ovarian stimulation and embryo retrieval within 4 months. The primary objective is to assess whether ovarian cortex multi-point puncture during the initial oocyte retrieval procedure improves ovarian reserve and ovarian stimulation outcomes compared to conventional oocyte retrieval. The study plans to continuously recruit 214 participants across seven participating centers.
The study period for the research subjects comprises three phases: screening and baseline phase, intervention phase, and follow-up phase.
During the screening and baseline phase, patients scheduled for IVF/ICSI artificial reproduction with plans to undergo ovarian stimulation, oocyte retrieval, embryo transfer, and DOR within 4 months were invited to participate in this study. Written informed consent forms were provided to potential participants, with detailed explanations of the study protocol. Prior to implementing any specific study procedures, written informed consent from participants (or their legal representatives) was obtained. After signing the informed consent form, participants were randomly assigned to the intervention group or control group using a stratified block randomization method (with research centers as stratification factors) at a 1:1 ratio, followed by baseline data collection.
During the intervention period, on the day of oocyte retrieval after the first ovarian stimulation cycle, the control group underwent conventional anesthesia (intravenous anesthesia or sedation) followed by standard oocyte retrieval procedures according to institutional protocols. A standard 17G double-lumen oocyte retrieval needle was used with transvaginal ultrasound guidance and puncture guide frame. The intervention group completed conventional oocyte retrieval under the same anesthesia/sedation conditions and immediately underwent ovarian cortical multi-point puncture under ultrasound guidance (without needle replacement). The procedure involved selecting the ovary with relatively fewer follicles larger than 14mm and establishing two evenly distributed puncture sites in the cortical region. For patients requiring continued ovarian stimulation therapy prior to the second oocyte retrieval, the ovarian stimulation protocol remained consistent with the previous cycle. Detailed records were maintained for the stimulation regimen, medication dosages, oocyte retrieval puncture documentation, and adverse event occurrences.
During the follow-up period, study subjects undergoing IVF/ICSI treatment were monitored for pregnancy outcomes (biochemical pregnancy rate, implantation rate, clinical pregnancy rate, miscarriage rate (early ≤12 weeks and mid-to-late <28 weeks), live birth rate, cumulative pregnancy rate, cumulative live birth rate), neonatal outcomes (preterm birth, stillbirth, low birth weight infants, birth defects), and adverse event-related data.
- Conditions
- Diminished Ovarian Reserve (DOR)
- Being tested
- multiple ovarian cortex punctures, routine oocyte retrieval procedure
- Keywords
- Diminished ovarian reserve (DOR), RCT, cortex punctures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple ovarian cortex puncturesProcedure or surgery
During the intervention period, on the day of oocyte retrieval after the first ovarian stimulation cycle, the control group underwent conventional anesthesia (intravenous anesthesia or sedation) followed by standard oocyte retrieval procedures according to institutional protocols. A standard 17G double-lumen oocyte retrieval needle was used with transvaginal ultrasound guidance and puncture guide frame. The intervention group completed conventional oocyte retrieval under the same anesthesia/sedation conditions and immediately underwent ovarian cortical multi-point puncture under ultrasound guidance (without needle replacement).
routine oocyte retrieval procedureOther
Equipment preparation:Oocyte retrieval puncture needle(Standard 17G double-lumen oocyte retrieval needle),Transvaginal ultrasound probe and puncture guidance frame, Sterile gloves, disinfectant solution, sterile gauze; Patient Preparation:Verify patient identity,Routine pre-oocyte retrieval preparations (bladder emptying, vulvar disinfection, etc.),Anesthesia method: According to the standard practice of each center (intravenous anesthesia or sedation); Oocyte retrieval procedure (identical in both groups):The procedure was performed according to the standard oocyte retrieval protocols of each center, with ovarian follicle aspiration completed under transvaginal ultrasound guidance. All target follicles were confirmed to have undergone complete aspiration of follicular fluid.
| Study group | Role | What they receive |
|---|---|---|
| intervention group (multiple ovarian cortex puncture) | Experimental | The intervention group underwent combined ovarian cortex multi-point puncture in addition to conventional oocyte retrieval procedures (identical to the control group). Specifically, after completing standard oocyte retrieval under the same anesthesia/sedation conditions, multi-point ovarian cortex puncture was performed without needle replacement. The procedure was guided by real-time ultrasound to ensure operational accuracy and visualization. On ultrasound imaging, three puncture sites were selected from the ovarian cortex region (avoiding residual follicles, corpus luteum, and medullary vascular areas) for uniform distribution: the first puncture point was aligned with the oocyte retrieval puncture line, followed by the second and third puncture points located approximately 5 mm to either side of the first point after exiting the ovarian surface. Receives: Procedure: multiple ovarian cortex punctures |
| control group (conventional oocyte retrieval procedure) | Other | Control measures (routine oocyte retrieval procedure):The procedure was performed according to the standard oocyte retrieval protocols of each center, with ovarian follicle aspiration completed under transvaginal ultrasound guidance. All target follicles were confirmed to have undergone complete aspiration of follicular fluid. Receives: Other: routine oocyte retrieval procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved during the second ovarian stimulation cycle
Number of oocytes retrieved during the second ovarian stimulation cycle in DOR patients (recorded separately by investigators unaware of group assignments for left and right ovaries).
Measured: The assessment period lasts up to 4 months, from the date of randomization to the completion of the second ovarian stimulation and oocyte retrieval.
Secondary outcomes (10)
Key reproductive-related indicators for the second ovarian stimulation and oocyte retrieval cycle
Antral follicle count (AFC), anti-Müllerian hormone (AMH), number of follicles ≥14mm on HCG day, number of MII-stage follicles, number of fertilizations, number of 2pn embryos, number of embryos, and number of high-quality embryos;
Measured: From the date of randomization to the third month after the second ovulation induction and oocyte retrieval surgery, the assessment period can last up to 7 months.
Rate of biochemical pregnancy
A blood pregnancy test is performed 14 days after embryo transfer. A positive result is defined as biochemical pregnancy. The rate of biochemical pregnancy is calculated using the following formula: (Number of cycles with positive blood hCG / Number of transfer cycles) × 100%.
Measured: From the date of randomization to the occurrence of biochemical pregnancy after this embryo transfer, the assessment period can last up to 24 months.
Clinical pregnancy rate
Transvaginal ultrasound examination performed 4-5 weeks after embryo transfer is conducted. If intrauterine gestational sac, ectopic pregnancy, or combined intrauterine and extrauterine pregnancy is detected, it is classified as clinical pregnancy. The clinical pregnancy rate is calculated using the following formula: (Number of cycles with clinical pregnancy / Total number of embryo transfer cycles) × 100%.
Measured: From the date of randomization to clinical pregnancy after this embryo transfer, the assessment period can last up to 24 months.
Implantation rate
Transvaginal ultrasound examination performed 4-5 weeks after embryo transfer. If intrauterine or ectopic gestational sacs are detected, implantation is confirmed. (Number of gestational sacs / Number of transferred embryos) × 100%
Measured: From the date of randomization to implantation at the 5th week after embryo transfer, the assessment period can last up to 24 months.
Abortion rate
Early abortion rate (number of cycles with miscarriage occurring before 12 weeks / total clinical pregnancy cycles) × 100%; Mid-to-late abortion rate (number of cycles with miscarriage occurring between 12 weeks and 28 weeks / total clinical pregnancy cycles) × 100%.
Measured: From the date of randomization to miscarriage after this embryo transfer, the assessment period can last up to 30 months.
Live birth rate
(Number of transplant cycles achieving at least one full-term live birth at 28 weeks / Total number of transplant cycles) × 100%
Measured: From the date of randomization to the birth of a full-term live fetus following this embryo transfer, the assessment period lasts up to 36 months.
Cumulative pregnancy rate
The proportion of patients who ultimately achieve clinical pregnancy, calculated until all transplantable embryos obtained from two consecutive IVF/ICSI cycles are exhausted.
Measured: From the date of randomization to clinical pregnancy after exhaustion of transplantable embryos, the assessment period lasts up to 100 months.
Cumulative live birth rate
The proportion of patients who ultimately achieved live births (gestation ≥28 weeks) using transplantable embryos obtained from two consecutive IVF/ICSI cycles until all embryos were exhausted.
Measured: From the date of randomization to the birth of a full-term live fetus after exhaustion of transplantable embryos, the assessment period lasts up to 100 months.
Adverse neonatal outcomes
primarily including preterm birth, stillbirth, low birth weight infants, and birth defects;
Measured: From the date of randomization to one year after the birth of the newborn, the assessment period can last up to 100 months.
Incidence of adverse events
Adverse events and serious adverse events, with a focus on evaluating the incidence of puncture-related adverse events (e.g., bleeding, injury, infection).
Measured: From the date of randomization to the date of adverse event occurrence, the assessment period lasts up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian Reserve (DOR)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Maternity and Child Health Care Hospital, Qinzhou Maternity and Child Health Care Hospital, The First Affiliated Hospital of Xiamen University, Guigang city People's Hospital, LiuZhou People's Hospital, Nanning Second People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568639
- Sponsor's protocol ID
- YYZS2021001002
- Other IDs
- YYZS2021001
- Acronym
- MSCPD
- Status last verified
- Mar 2026
- First submitted
- 12 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Multiple Ovarian Cortex Punctures in Improving Ovarian Reserve and Ovarian Stimulation Outcomes in Patients With Diminished Ovarian Reserve (DOR): A Multicenter, Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07568639
- Acronym / sponsor ID
- MSCPD / YYZS2021001002
- Conditions
- Diminished Ovarian Reserve (DOR)
- Keywords
- Diminished ovarian reserve (DOR), RCT, cortex punctures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Maternity and Child Health Care Hospital, Qinzhou Maternity and Child Health Care Hospital, The First Affiliated Hospital of Xiamen University, Guigang city People's Hospital, LiuZhou People's Hospital, Nanning Second People's Hospital
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 6 May 2026 (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.
A multicenter, prospective, randomized controlled clinical trial. The target population consists of patients undergoing IVF/ICSI artificial reproduction who plan to undergo ovarian stimulation and embryo retrieval (DOR) within 4 months. A stratified block randomization method was employed to assign participants in a 1:1 ratio to the intervention group and control group. The study aims to investigate whether multiple-point ovarian cortex puncture during the initial oocyte retrieval procedure improves ovarian reserve and ovarian stimulation outcomes in DOR patients compared to conventional oocyte retrieval techniques.
Detailed description
This is a multicenter, prospective, randomized controlled clinical trial designed to evaluate the efficacy of ovarian cortex multi-point puncture in improving ovarian reserve and ovarian stimulation outcomes in patients with delayed ovarian reserve (DOR). The target population consists of DOR patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) with plans for subsequent ovarian stimulation and embryo retrieval within 4 months. The primary objective is to assess whether ovarian cortex multi-point puncture during the initial oocyte retrieval procedure improves ovarian reserve and ovarian stimulation outcomes compared to conventional oocyte retrieval. The study plans to continuously recruit 214 participants across seven participating centers.
The study period for the research subjects comprises three phases: screening and baseline phase, intervention phase, and follow-up phase.
During the screening and baseline phase, patients scheduled for IVF/ICSI artificial reproduction with plans to undergo ovarian stimulation, oocyte retrieval, embryo transfer, and DOR within 4 months were invited to participate in this study. Written informed consent forms were provided to potential participants, with detailed explanations of the study protocol. Prior to implementing any specific study procedures, written informed consent from participants (or their legal representatives) was obtained. After signing the informed consent form, participants were randomly assigned to the intervention group or control group using a stratified block randomization method (with research centers as stratification factors) at a 1:1 ratio, followed by baseline data collection.
During the intervention period, on the day of oocyte retrieval after the first ovarian stimulation cycle, the control group underwent conventional anesthesia (intravenous anesthesia or sedation) followed by standard oocyte retrieval procedures according to institutional protocols. A standard 17G double-lumen oocyte retrieval needle was used with transvaginal ultrasound guidance and puncture guide frame. The intervention group completed conventional oocyte retrieval under the same anesthesia/sedation conditions and immediately underwent ovarian cortical multi-point puncture under ultrasound guidance (without needle replacement). The procedure involved selecting the ovary with relatively fewer follicles larger than 14mm and establishing two evenly distributed puncture sites in the cortical region. For patients requiring continued ovarian stimulation therapy prior to the second oocyte retrieval, the ovarian stimulation protocol remained consistent with the previous cycle. Detailed records were maintained for the stimulation regimen, medication dosages, oocyte retrieval puncture documentation, and adverse event occurrences.
During the follow-up period, study subjects undergoing IVF/ICSI treatment were monitored for pregnancy outcomes (biochemical pregnancy rate, implantation rate, clinical pregnancy rate, miscarriage rate (early ≤12 weeks and mid-to-late <28 weeks), live birth rate, cumulative pregnancy rate, cumulative live birth rate), neonatal outcomes (preterm birth, stillbirth, low birth weight infants, birth defects), and adverse event-related data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group (multiple ovarian cortex puncture) | Experimental | Procedure: multiple ovarian cortex puncturesThe intervention group underwent combined ovarian cortex multi-point puncture in addition to conventional oocyte retrieval procedures (identical to the control group). Specifically, after completing standard oocyte retrieval under the same anesthesia/sedation conditions, multi-point ovarian cortex puncture was performed without needle replacement. The procedure was guided by real-time ultrasound to ensure operational accuracy and visualization. On ultrasound imaging, three puncture sites were selected from the ovarian cortex region (avoiding residual follicles, corpus luteum, and medullary vascular areas) for uniform distribution: the first puncture point was aligned with the oocyte retrieval puncture line, followed by the second and third puncture points located approximately 5 mm to either side of the first point after exiting the ovarian surface. |
| control group (conventional oocyte retrieval procedure) | Other | Other: routine oocyte retrieval procedureControl measures (routine oocyte retrieval procedure):The procedure was performed according to the standard oocyte retrieval protocols of each center, with ovarian follicle aspiration completed under transvaginal ultrasound guidance. All target follicles were confirmed to have undergone complete aspiration of follicular fluid. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 20-45 years;
- Infertile women meeting the diagnostic criteria for diminished ovarian reserve (DOR); The following two criteria must be met simultaneously: ① Anti-Müllerian hormone (AMH) ≤0.5 ng/ml, ② Bilateral ovarian antral follicles (AFC) ≤5 (3-9 mm).
- Patients scheduled for IVF (in vitro fertilization)/ICSI (intracytoplasmic sperm injection) treatment;
- Patients who plan for whole embryo cryopreservation and intend to undergo another ovulation induction cycle within 4 natural months starting from the first cycle, with the goal of embryo retrieval and embryo banking;
- Bilateral follicles were observed during AFC examination;
Key exclusion criteria (9 listed)
- Patients with the following reproductive and gynecological comorbidities: history of salpingectomy, ovarian cysts (e.g., chocolate cysts), ovarian tumors, or simple cysts ≥10 mm (not eligible for enrollment in the current cycle; may be enrolled after regression), history of ovarian surgery, endometriosis or adenomyosis, or acute pelvic inflammatory disease;
- Patients with abnormal ovarian position who are expected to experience difficulties during oocyte retrieval puncture;
- Patients with concomitant systemic severe diseases (history of severe chronic diseases such as heart failure, myocardial infarction, stroke, end-stage renal disease; advanced cancer or other terminal illnesses with an estimated survival period of less than 6 months; coagulation disorders; uncontrolled sepsis; autoimmune diseases; poor general condition rendering anesthesia and surgery intolerable);
- Patients with contraindications to hormone replacement therapy;
- Currently undergoing treatment with cytotoxic drugs, glucocorticoids or other immunosuppressants, radiotherapy or chemotherapy, or having previously received radiotherapy or chemotherapy;
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 |
|---|---|---|
| multiple ovarian cortex puncturesDuring the intervention period, on the day of oocyte retrieval after the first ovarian stimulation cycle, the control group underwent conventional anesthesia (intravenous anesthesia or sedation) followed by standard oocyte retrieval procedures according to institutional protocols. A standard 17G double-lumen oocyte retrieval needle was used with transvaginal ultrasound guidance and puncture guide frame. The intervention group completed conventional oocyte retrieval under the same anesthesia/sedation conditions and immediately underwent ovarian cortical multi-point puncture under ultrasound guidance (without needle replacement). | Procedure or surgery | intervention group (multiple ovarian cortex puncture) |
| routine oocyte retrieval procedureEquipment preparation:Oocyte retrieval puncture needle(Standard 17G double-lumen oocyte retrieval needle),Transvaginal ultrasound probe and puncture guidance frame, Sterile gloves, disinfectant solution, sterile gauze; Patient Preparation:Verify patient identity,Routine pre-oocyte retrieval preparations (bladder emptying, vulvar disinfection, etc.),Anesthesia method: According to the standard practice of each center (intravenous anesthesia or sedation); Oocyte retrieval procedure (identical in both groups):The procedure was performed according to the standard oocyte retrieval protocols of each center, with ovarian follicle aspiration completed under transvaginal ultrasound guidance. All target follicles were confirmed to have undergone complete aspiration of follicular fluid. | Other | control group (conventional oocyte retrieval procedure) |
Primary outcome
Number of oocytes retrieved during the second ovarian stimulation cycle
Time frame: The assessment period lasts up to 4 months, from the date of randomization to the completion of the second ovarian stimulation and oocyte retrieval.
Number of oocytes retrieved during the second ovarian stimulation cycle in DOR patients (recorded separately by investigators unaware of group assignments for left and right ovaries).
10 secondary outcomes
Key reproductive-related indicators for the second ovarian stimulation and oocyte retrieval cycle
Time frame: From the date of randomization to the third month after the second ovulation induction and oocyte retrieval surgery, the assessment period can last up to 7 months.
Rate of biochemical pregnancy
Time frame: From the date of randomization to the occurrence of biochemical pregnancy after this embryo transfer, the assessment period can last up to 24 months.
Clinical pregnancy rate
Time frame: From the date of randomization to clinical pregnancy after this embryo transfer, the assessment period can last up to 24 months.
Implantation rate
Time frame: From the date of randomization to implantation at the 5th week after embryo transfer, the assessment period can last up to 24 months.
Abortion rate
Time frame: From the date of randomization to miscarriage after this embryo transfer, the assessment period can last up to 30 months.
Live birth rate
Time frame: From the date of randomization to the birth of a full-term live fetus following this embryo transfer, the assessment period lasts up to 36 months.
Cumulative pregnancy rate
Time frame: From the date of randomization to clinical pregnancy after exhaustion of transplantable embryos, the assessment period lasts up to 100 months.
Cumulative live birth rate
Time frame: From the date of randomization to the birth of a full-term live fetus after exhaustion of transplantable embryos, the assessment period lasts up to 100 months.
Adverse neonatal outcomes
Time frame: From the date of randomization to one year after the birth of the newborn, the assessment period can last up to 100 months.
Incidence of adverse events
Time frame: From the date of randomization to the date of adverse event occurrence, the assessment period lasts up to 100 months.
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 6 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multiple ovarian cortex punctures and routine oocyte retrieval procedure in people with Diminished Ovarian Reserve (DOR), run by First Affiliated Hospital of Guangxi Medical University at 7 sites in China.
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 8 inclusion and 9 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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 Yihua Yang, Doctor (86-0771-5356126, workyyh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oocytes retrieved during the second ovarian stimulation cycle (time frame: The assessment period lasts up to 4 months, from the date of randomization to the completion of the second ovarian stimulation and oocyte retrieval.). 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 6 May 2026.