Infertility, FemaleSISTERNCT07175571
SISTER: Sibling Oocyte Insemination With Frozen Sperm From Third Party Donors: Evaluation of Reproductive Techniques
A study testing Intracytoplasmic Sperm Injection (ICSI) and Conventional Insemination (IVF) in people with Infertility, Female and Reproductive Techniques, Assisted, run by Shady Grove Fertility Reproductive Science Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether two different methods of helping eggs and sperm join-intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF)-lead to better embryo development when using frozen donor sperm in people who do not have male fertility problems. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Female, Reproductive Techniques, Assisted, Fertilization in Vitro
- What is being tested?
- Intracytoplasmic Sperm Injection (ICSI) and Conventional Insemination (IVF)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 1 May 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female patients undergoing IVF with frozen donor sperm at Shady Grove Fertility Center
- Normal ovarian reserve (AMH > 1 ng/mL, AFC > 10)
- Absence of male factor infertility
- Post-wash parameters: >50% motility, >5mil concentration
- > 4 oocytes retrieved at time of transvaginal oocyte retrieval
Who cannot join
- Donor Sperm with significant male factor infertility (e.g., abnormal sperm concentration, motility, or morphology)
- Any medical condition contraindicating ART
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shady Grove Fertility Rockville
Rockville, Maryland, 20850
Tasha Newsome, 301-545-1289, Tasha.Newsome@sgfertility.com
Allison Eubanks, MD
About this study
Official title: Prospective Randomized Sibling-Oocyte Trial Comparing Fertilization and Embryo Development Outcomes Between Intracytoplasmic Sperm Injection (ICSI) and Conventional IVF Using Frozen Donor Sperm
The goal of this clinical trial is to learn whether two different methods of helping eggs and sperm join-intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF)-lead to better embryo development when using frozen donor sperm in people who do not have male fertility problems. The main questions it aims to answer are:
Does one method create more usable embryos (blastocysts) than the other?
Read more
Is there a difference in how often fertilization does not happen at all?
Do either of the methods lead to better embryo quality or early pregnancy?
Participants will:
Have their eggs divided into two groups. One group will be fertilized using ICSI (where a sperm is injected directly into an egg), and the other using conventional IVF (where eggs are mixed with sperm in a dish).
The fertilization method for each egg will be randomly assigned, with a random process also used to determine the assignment of any extra egg when an odd number is collected.
Continue regular fertility treatment while the study team compares the results of each fertilization method.
This study includes people with non-male factor infertility and uses frozen donor sperm. It hopes to learn whether ICSI, which is often used even when it may not be needed, truly helps improve outcomes compared to conventional IVF in these cases.
Read the detailed description
This is a prospective, randomized sibling-oocyte controlled trial designed to compare fertilization and embryo development outcomes between intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF) using cryopreserved donor sperm in non-male factor infertility cycles. Despite widespread use of ICSI in assisted reproductive technology (ART), there is insufficient evidence supporting its routine use in non-male factor indications, especially in cycles utilizing frozen sperm where male factor infertility is not a contributing variable.
The study aims to address ongoing clinical debate and practice variation by evaluating whether ICSI offers meaningful advantages over conventional IVF in this specific context. Previous retrospective and meta-analytic data have suggested that while ICSI may reduce total fertilization failure (TFF), it may not improve-and may even negatively impact-other key clinical outcomes such as blastulation rate, embryo quality, and early pregnancy rates in non-male factor populations. Additionally, concerns about increased pregnancy-related complications with ICSI have been raised.
To reduce inter-patient variability and enhance internal validity, a sibling-oocyte design will be employed, allowing within-patient comparison of insemination methods. Oocytes retrieved from each participant will be randomized to either ICSI or conventional IVF. Randomization will be conducted prior to oocyte retrieval using computer-generated allocation. For patients with an even number of mature oocytes, half will be assigned to each insemination method. For those with an odd number, the extra oocyte will be randomly allocated according to the pre-specified scheme.
The fertilization process will begin shortly after oocyte retrieval. In the conventional IVF arm, mature oocytes will be inseminated using washed frozen-thawed donor sperm at a standard concentration and co-incubated for 16-18 hours. In the ICSI arm, a single motile sperm will be injected directly into each mature oocyte. All oocytes will undergo standard embryological assessment post-insemination, and embryos will be cultured under identical conditions.
The primary endpoint is the blastulation rate, defined as the number of usable blastocysts (meeting lab criteria for cryopreservation or transfer) per number of oocytes inseminated in each arm. Secondary outcomes include:
- Fertilization rate: number of 2PN zygotes per oocyte inseminated
- Incidence of TFF: no oocytes fertilized in a given arm
- Proportion of high-quality blastocysts, defined as grade BB or higher
- Early clinical pregnancy rate, as determined by ultrasound-confirmed intrauterine gestation Statistical analysis will use generalized estimating equations (GEE) for the primary outcome at the oocyte level to account for clustering within patients. Secondary outcomes will be analyzed using chi-square or Fisher's exact tests as appropriate. All data will be analyzed on an intention-to-treat basis.
The study will enroll approximately 178 participants over 12 months at Shady Grove Fertility, where frozen donor sperm with normal post-thaw parameters is routinely available. Only non-male factor infertility patients using frozen donor sperm will be eligible, ensuring a controlled sperm quality baseline across study arms.
The hypothesis is that conventional IVF will demonstrate equivalent or superior blastulation rates compared to ICSI, with non-inferior fertilization outcomes and potentially better embryo morphology. Results from this trial will help refine clinical guidelines and may support a more evidence-based, resource-efficient use of ICSI.
IRB approval has been obtained, and informed consent will be secured from all participants. All procedures will adhere to Good Clinical Practice and applicable regulatory guidelines. Data confidentiality will be maintained throughout.
- Being tested
- Intracytoplasmic Sperm Injection (ICSI), Conventional Insemination (IVF)
- Keywords
- Intracytoplasmic Sperm Injection (ICSI), Conventional IVF, Frozen Donor Sperm, Sibling-Oocyte Design, Non-Male Factor Infertility, Blastulation Rate, Total Fertilization Failure (TFF), Fertilization Outcomes, Embryo Quality, Clinical Pregnancy Rate, Assisted Reproductive Technology (ART), Embryo Development, In Vitro Fertilization, Oocyte Randomization, Female Infertility, Cryopreserved Sperm, Randomized Controlled Trial (RCT), Reproductive Medicine, Fertility Treatment
- Medical subject headings
- Infertility, Female, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracytoplasmic Sperm Injection (ICSI)Procedure or surgery
Mature oocytes are injected with a single frozen-thawed donor sperm cell using micromanipulation under a microscope. This fertilization method is performed shortly after oocyte retrieval. Sperm used are pre-screened and standardized for post-thaw motility and morphology. ICSI is conducted in accordance with standard embryology lab protocols. The oocyte allocation to ICSI is randomized within each participant's cycle.
Conventional Insemination (IVF)Procedure or surgery
Oocytes are inseminated by co-incubation with frozen-thawed donor sperm in a culture dish for 16-18 hours. Sperm are washed and prepared according to lab protocol to ensure motility and concentration suitability. This method does not involve direct sperm injection. Oocytes are randomly assigned to this method within each participant's retrieved cohort.
| Study group | Role | What they receive |
|---|---|---|
| Intracytoplasmic Sperm Injection (ICSI) | Experimental | In this arm, a portion of each participant's mature oocytes will be inseminated using intracytoplasmic sperm injection (ICSI). A single frozen-thawed donor sperm cell will be injected directly into each oocyte using micromanipulation techniques. The oocyte assignment to ICSI will be determined through randomized sibling-oocyte allocation. Embryos will be cultured under standard laboratory conditions and assessed for fertilization (2PN), blastulation, embryo quality, and early clinical pregnancy outcomes. Receives: Procedure: Intracytoplasmic Sperm Injection (ICSI) |
| Conventional Insemination (IVF) | Experimental | In this arm, a portion of each participant's oocytes will be inseminated using the conventional in vitro fertilization (IVF) method. Frozen-thawed donor sperm with normal post-thaw parameters will be co-incubated with oocytes in culture media for fertilization. The oocyte assignment to this method will be determined through randomized sibling-oocyte allocation. Embryos will be cultured under the same laboratory conditions and assessed for fertilization (2PN), blastulation, embryo quality, and early clinical pregnancy outcomes. Receives: Procedure: Conventional Insemination (IVF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastulation Rate
The blastulation rate is defined as the number of "usable" blastocysts divided by the number of oocytes inseminated in each arm (ICSI and conventional IVF). A blastocyst is considered "usable" if it meets laboratory criteria for either cryopreservation or embryo transfer. Assessment is performed on Days 5-7 after fertilization using standard morphological grading under light microscopy.
Measured: Day 5 to Day 7 post-insemination
Secondary outcomes (4)
Fertilization Rate
The fertilization rate is the number of oocytes that develop two pronuclei (2PN), indicating successful fertilization, divided by the total number of oocytes inseminated. Oocytes are assessed approximately 16-18 hours after insemination. A 2PN zygote is a marker of normal fertilization in IVF/ICSI cycles.
Measured: Approximately 16-18 hours post-insemination
Total Fertilization Failure (TFF)
TFF is defined as the percentage of insemination arms (either ICSI or conventional IVF) within a cycle that result in zero fertilized oocytes (0% 2PN). This is assessed at the patient level. For example, if none of the oocytes in the conventional IVF group fertilize, that arm is considered to have experienced TFF.
Measured: Approximately 16-18 hours post-insemination
Proportion of High-Quality Blastocysts
This outcome measures the proportion of blastocysts graded BB or higher on standard morphological grading scales. Embryos are assessed on Days 5-7 post-insemination. Blastocyst quality is determined based on expansion, inner cell mass, and trophectoderm appearance. Only embryos reaching the blastocyst stage are included in this metric.
Measured: Day 5 to Day 7 post-insemination
Early Clinical Pregnancy Rate
Early clinical pregnancy is confirmed by the presence of a gestational sac visualized on transvaginal ultrasound, typically around 5-7 weeks after embryo transfer. The rate is calculated as the percentage of embryo transfer cycles in which at least one intrauterine pregnancy is confirmed.
Measured: Approximately 5 to 7 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- Crossover
- Model description
- This is a randomized sibling-oocyte controlled trial in which each participant's retrieved oocytes are split between two insemination methods: intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF). Randomization occurs at the oocyte level, not at the participant level. For participants with an even number of mature oocytes, half are randomly assigned to ICSI and half to conventional IVF. For participants with an odd number, the extra oocyte is randomly allocated using a pre-specified scheme. This within-subject design allows direct comparison of fertilization and embryo development outcomes between the two methods while minimizing inter-patient variability.
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shady Grove Fertility Reproductive Science Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Devine, Shady Grove Fertility Reproductive Science Center
- Investigators
- Kate Devine, MD, Study chair, Shady Grove Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175571
- Sponsor's protocol ID
- SISTER Study
- Acronym
- SISTER
- Status last verified
- May 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romero-Galisteo RP, Pinero-Pinto E, Palomo-Carrion R, Luque-Moreno C, Molina-Torres G, Gonzalez-Sanchez M. Translation, cross-cultural adaptation and validation of the Rett syndrome motor evaluation scale (RESMES): Spanish version. Eur J Paediatr Neurol. 2023 Nov;47:72-79. doi: 10.1016/j.ejpn.2023.09.008. Epub 2023 Sep 28.
PubMed 37788534Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.
PubMed 1351601Hao G, Zhou X, Yan H, Wang X, Qiao L, Ni D, Shu W, Yu T. Emotional experience elicited by direct electrical stimulation: Case series and literature review. Epilepsia Open. 2023 Jun;8(2):547-558. doi: 10.1002/epi4.12729. Epub 2023 Apr 4.
PubMed 36932033Mao Z, Yao H, Zou Q, Zhang W, Dong Y. Digital Contact Tracing Based on a Graph Database Algorithm for Emergency Management During the COVID-19 Epidemic: Case Study. JMIR Mhealth Uhealth. 2021 Jan 22;9(1):e26836. doi: 10.2196/26836.
PubMed 33460389Teodorescu M, Barnet JH, Hagen EW, Palta M, Young TB, Peppard PE. Association between asthma and risk of developing obstructive sleep apnea. JAMA. 2015 Jan 13;313(2):156-64. doi: 10.1001/jama.2014.17822.
PubMed 25585327Mo DY, Tang YM, Wu EY, Tang V. Theoretical model of investigating determinants for a successful Electronic Assessment System (EAS) in higher education. Educ Inf Technol (Dordr). 2022;27(9):12543-12566. doi: 10.1007/s10639-022-11098-1. Epub 2022 Jun 3.
PubMed 35676938Zhang R, Xu S, Yuan M, Guo L, Xie L, Liao Y, Xu Y, Fu X. An ultrasmall PVP-Fe-Cu-Ni-S nano-agent for synergistic cancer therapy through triggering ferroptosis and autophagy. Nanoscale. 2023 Aug 3;15(30):12598-12611. doi: 10.1039/d3nr02708b.
PubMed 37462439
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Sibling-Oocyte Trial Comparing Fertilization and Embryo Development Outcomes Between Intracytoplasmic Sperm Injection (ICSI) and Conventional IVF Using Frozen Donor Sperm
- ClinicalTrials.gov ID
- NCT07175571
- Acronym / sponsor ID
- SISTER / SISTER Study
- Keywords
- Intracytoplasmic Sperm Injection (ICSI), Conventional IVF, Frozen Donor Sperm, Sibling-Oocyte Design, Non-Male Factor Infertility, Blastulation Rate, Total Fertilization Failure (TFF), Fertilization Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Shady Grove Fertility Reproductive Science CenterUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 16 Sep 2025 (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.
The goal of this clinical trial is to learn whether two different methods of helping eggs and sperm join-intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF)-lead to better embryo development when using frozen donor sperm in people who do not have male fertility problems. The main questions it aims to answer are:
Does one method create more usable embryos (blastocysts) than the other?
Is there a difference in how often fertilization does not happen at all?
Do either of the methods lead to better embryo quality or early pregnancy?
Participants will:
Have their eggs divided into two groups. One group will be fertilized using ICSI (where a sperm is injected directly into an egg), and the other using conventional IVF (where eggs are mixed with sperm in a dish).
The fertilization method for each egg will be randomly assigned, with a random process also used to determine the assignment of any extra egg when an odd number is collected.
Continue regular fertility treatment while the study team compares the results of each fertilization method.
This study includes people with non-male factor infertility and uses frozen donor sperm. It hopes to learn whether ICSI, which is often used even when it may not be needed, truly helps improve outcomes compared to conventional IVF in these cases.
Detailed description
This is a prospective, randomized sibling-oocyte controlled trial designed to compare fertilization and embryo development outcomes between intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF) using cryopreserved donor sperm in non-male factor infertility cycles. Despite widespread use of ICSI in assisted reproductive technology (ART), there is insufficient evidence supporting its routine use in non-male factor indications, especially in cycles utilizing frozen sperm where male factor infertility is not a contributing variable.
The study aims to address ongoing clinical debate and practice variation by evaluating whether ICSI offers meaningful advantages over conventional IVF in this specific context. Previous retrospective and meta-analytic data have suggested that while ICSI may reduce total fertilization failure (TFF), it may not improve-and may even negatively impact-other key clinical outcomes such as blastulation rate, embryo quality, and early pregnancy rates in non-male factor populations. Additionally, concerns about increased pregnancy-related complications with ICSI have been raised.
To reduce inter-patient variability and enhance internal validity, a sibling-oocyte design will be employed, allowing within-patient comparison of insemination methods. Oocytes retrieved from each participant will be randomized to either ICSI or conventional IVF. Randomization will be conducted prior to oocyte retrieval using computer-generated allocation. For patients with an even number of mature oocytes, half will be assigned to each insemination method. For those with an odd number, the extra oocyte will be randomly allocated according to the pre-specified scheme.
The fertilization process will begin shortly after oocyte retrieval. In the conventional IVF arm, mature oocytes will be inseminated using washed frozen-thawed donor sperm at a standard concentration and co-incubated for 16-18 hours. In the ICSI arm, a single motile sperm will be injected directly into each mature oocyte. All oocytes will undergo standard embryological assessment post-insemination, and embryos will be cultured under identical conditions.
The primary endpoint is the blastulation rate, defined as the number of usable blastocysts (meeting lab criteria for cryopreservation or transfer) per number of oocytes inseminated in each arm. Secondary outcomes include:
- Fertilization rate: number of 2PN zygotes per oocyte inseminated
- Incidence of TFF: no oocytes fertilized in a given arm
- Proportion of high-quality blastocysts, defined as grade BB or higher
- Early clinical pregnancy rate, as determined by ultrasound-confirmed intrauterine gestation Statistical analysis will use generalized estimating equations (GEE) for the primary outcome at the oocyte level to account for clustering within patients. Secondary outcomes will be analyzed using chi-square or Fisher's exact tests as appropriate. All data will be analyzed on an intention-to-treat basis.
The study will enroll approximately 178 participants over 12 months at Shady Grove Fertility, where frozen donor sperm with normal post-thaw parameters is routinely available. Only non-male factor infertility patients using frozen donor sperm will be eligible, ensuring a controlled sperm quality baseline across study arms.
The hypothesis is that conventional IVF will demonstrate equivalent or superior blastulation rates compared to ICSI, with non-inferior fertilization outcomes and potentially better embryo morphology. Results from this trial will help refine clinical guidelines and may support a more evidence-based, resource-efficient use of ICSI.
IRB approval has been obtained, and informed consent will be secured from all participants. All procedures will adhere to Good Clinical Practice and applicable regulatory guidelines. Data confidentiality will be maintained throughout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized sibling-oocyte controlled trial in which each participant's retrieved oocytes are split between two insemination methods: intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (IVF). Randomization occurs at the oocyte level, not at the participant level. For participants with an even number of mature oocytes, half are randomly assigned to ICSI and half to conventional IVF. For participants with an odd number, the extra oocyte is randomly allocated using a pre-specified scheme. This within-subject design allows direct comparison of fertilization and embryo development outcomes between the two methods while minimizing inter-patient variability.
| Arm | Type | Receives |
|---|---|---|
| Intracytoplasmic Sperm Injection (ICSI) | Experimental | Procedure: Intracytoplasmic Sperm Injection (ICSI)In this arm, a portion of each participant's mature oocytes will be inseminated using intracytoplasmic sperm injection (ICSI). A single frozen-thawed donor sperm cell will be injected directly into each oocyte using micromanipulation techniques. The oocyte assignment to ICSI will be determined through randomized sibling-oocyte allocation. Embryos will be cultured under standard laboratory conditions and assessed for fertilization (2PN), blastulation, embryo quality, and early clinical pregnancy outcomes. |
| Conventional Insemination (IVF) | Experimental | Procedure: Conventional Insemination (IVF)In this arm, a portion of each participant's oocytes will be inseminated using the conventional in vitro fertilization (IVF) method. Frozen-thawed donor sperm with normal post-thaw parameters will be co-incubated with oocytes in culture media for fertilization. The oocyte assignment to this method will be determined through randomized sibling-oocyte allocation. Embryos will be cultured under the same laboratory conditions and assessed for fertilization (2PN), blastulation, embryo quality, and early clinical pregnancy outcomes. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients undergoing IVF with frozen donor sperm at Shady Grove Fertility Center
- Normal ovarian reserve (AMH > 1 ng/mL, AFC > 10)
- Absence of male factor infertility
- Post-wash parameters: >50% motility, >5mil concentration
- > 4 oocytes retrieved at time of transvaginal oocyte retrieval
Key exclusion criteria (2 listed)
- Donor Sperm with significant male factor infertility (e.g., abnormal sperm concentration, motility, or morphology)
- Any medical condition contraindicating ART
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 |
|---|---|---|
| Intracytoplasmic Sperm Injection (ICSI)Mature oocytes are injected with a single frozen-thawed donor sperm cell using micromanipulation under a microscope. This fertilization method is performed shortly after oocyte retrieval. Sperm used are pre-screened and standardized for post-thaw motility and morphology. ICSI is conducted in accordance with standard embryology lab protocols. The oocyte allocation to ICSI is randomized within each participant's cycle. | Procedure or surgery | Intracytoplasmic Sperm Injection (ICSI) |
| Conventional Insemination (IVF)Oocytes are inseminated by co-incubation with frozen-thawed donor sperm in a culture dish for 16-18 hours. Sperm are washed and prepared according to lab protocol to ensure motility and concentration suitability. This method does not involve direct sperm injection. Oocytes are randomly assigned to this method within each participant's retrieved cohort. | Procedure or surgery | Conventional Insemination (IVF) |
Primary outcome
Blastulation Rate
Time frame: Day 5 to Day 7 post-insemination
The blastulation rate is defined as the number of "usable" blastocysts divided by the number of oocytes inseminated in each arm (ICSI and conventional IVF). A blastocyst is considered "usable" if it meets laboratory criteria for either cryopreservation or embryo transfer. Assessment is performed on Days 5-7 after fertilization using standard morphological grading under light microscopy.
4 secondary outcomes
Fertilization Rate
Time frame: Approximately 16-18 hours post-insemination
Total Fertilization Failure (TFF)
Time frame: Approximately 16-18 hours post-insemination
Proportion of High-Quality Blastocysts
Time frame: Day 5 to Day 7 post-insemination
Early Clinical Pregnancy Rate
Time frame: Approximately 5 to 7 weeks after embryo transfer
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 16 Sep 2025.
- Background: PubMed 37788534Romero-Galisteo RP, Pinero-Pinto E, Palomo-Carrion R, Luque-Moreno C, Molina-Torres G, Gonzalez-Sanchez M. Translation, cross-cultural adaptation and validation of the Rett syndrome motor evaluation scale (RESMES): Spanish version. Eur J Paediatr Neurol. 2023 Nov;47:72-79. doi: 10.1016/j.ejpn.2023.09.008. Epub 2023 Sep 28.
- Background: PubMed 1351601Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.
- Background: PubMed 36932033Hao G, Zhou X, Yan H, Wang X, Qiao L, Ni D, Shu W, Yu T. Emotional experience elicited by direct electrical stimulation: Case series and literature review. Epilepsia Open. 2023 Jun;8(2):547-558. doi: 10.1002/epi4.12729. Epub 2023 Apr 4.
- Background: PubMed 33460389Mao Z, Yao H, Zou Q, Zhang W, Dong Y. Digital Contact Tracing Based on a Graph Database Algorithm for Emergency Management During the COVID-19 Epidemic: Case Study. JMIR Mhealth Uhealth. 2021 Jan 22;9(1):e26836. doi: 10.2196/26836.
- Background: PubMed 25585327Teodorescu M, Barnet JH, Hagen EW, Palta M, Young TB, Peppard PE. Association between asthma and risk of developing obstructive sleep apnea. JAMA. 2015 Jan 13;313(2):156-64. doi: 10.1001/jama.2014.17822.
- Background: PubMed 35676938Mo DY, Tang YM, Wu EY, Tang V. Theoretical model of investigating determinants for a successful Electronic Assessment System (EAS) in higher education. Educ Inf Technol (Dordr). 2022;27(9):12543-12566. doi: 10.1007/s10639-022-11098-1. Epub 2022 Jun 3.
- Background: PubMed 37462439Zhang R, Xu S, Yuan M, Guo L, Xie L, Liao Y, Xu Y, Fu X. An ultrasmall PVP-Fe-Cu-Ni-S nano-agent for synergistic cancer therapy through triggering ferroptosis and autophagy. Nanoscale. 2023 Aug 3;15(30):12598-12611. doi: 10.1039/d3nr02708b.
- Individual participant dataSharing planned: No
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
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.
Kate Devine, MD study chair
Shady Grove Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracytoplasmic Sperm Injection (ICSI) and Conventional Insemination (IVF) in people with Infertility, Female and Reproductive Techniques, Assisted, run by Shady Grove Fertility Reproductive Science Center at 1 site in United States.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Sep 2025. 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 United States. 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 Allison Eubanks, MD (301-400-2432, Allison.Eubanks@sgfertility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastulation Rate (time frame: Day 5 to Day 7 post-insemination). 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 NCT07175571, which also lists 7 linked publications.
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 16 Sep 2025.