Infertility, FemaleNCT03120884
Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age
A study testing ICSI and IVF in people with Infertility, Female and ART, run by International Peace Maternity and Child Health Hospital at 1 site in China.
Trial summary
This will be a prospective, randomized (1:1 ratio) clinical trial for non-male factor infertility in advanced maternal age with or without intracytoplasmic sperm injection(ICSI). Read more about this study
- Who is it for?
- Ages 38 to 50 years, women only
- Conditions the study is for
- Infertility, Female, ART
- What is being tested?
- ICSI and IVF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,422 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 1 Sep 2019
- 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 38 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients ages ≥38 years old with FSH ≤15;
- Spouse with normal sperm analysis according to WHO fifth edition criteria(sperm parameter values: total sperm count of at least 39 million, concentration≥15 × 106/ml, total motility ≥40%, progressive motility ≥32%， strict morphology ≥4% normal forms)；
- Female patients who intended to undergo IVF and had signed a written consent form.
Who cannot join
- More than three previous IVF cycles (including both failed cycles and cycles that ended in live births)
- Female patients with Ovulation dysfunction related disease, such as endometriosis, polycystic ovarian syndrome(tubal factors are not included); undiagnosed infertility; Female patients who have previously been diagnosed with a uterine abnormality such as a malformed uterus(uterus unicornis, septate uterus, duplex uterus or uterus bicomis), adenomyosis, submucous myoma or intrauterine adhesion;
- Spouse who have experienced recurrent spontaneous abortions (including biochemical pregnancy abortion), defined as three or more previous pregnancy losses;
- Patients or their partners with an abnormal chromosome karyotype not including chromosome polymorphisms, which mainly refer to the variants in the chromosomal heterochromatin region
- the use of donor oocytes or sperm;
- the use of frozen oocytes or sperm;
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- Femal patients with medical conditions that contraindicate assisted reproductive technology and/or pregnancy, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction(based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease; history of (or suspected) cervical carcinoma, endometrial carcinoma or breast carcinoma; and undiagnosed vaginal bleeding;
- Spouse with medical conditions that contraindicate assisted reproductive technology and/or pregnancy, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction(based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease;
- Female patients or their partners who are unable to comply with the study Procedures;
- Female patients who had previously been randomized to either of the two study groups in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
International Peace Maternity & Child Health Hospital
Shanghai, Shanghai Municipality, 200030
He-Feng Huang, MD, +86-21-18017310186, hefenghuang@126.com
About this study
This will be a prospective, randomized (1:1 ratio) clinical trial for non-male factor infertility in advanced maternal age with or without intracytoplasmic sperm injection(ICSI). Qualified 1422 patients are randomized into either of two groups: group A will undergo conventional in-vitro fertilization(IVF)(711 cases), Group B will undergo intracytoplasmic sperm injection (ICSI) (711 cases). All participants will receive the same protocol for ovarian stimulation and standardized luteal phase support.
The target population will be patients with non-male factor infertility aged ≥38years with FSH ≤15. Women with other reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are excluded.
The randomization will take place before controlled ovarian stimulation by a computer randomization system. The accumulated live birth rate , pregnancy complications will be followed up by checking medical records and telephone calls.
- Conditions
- Infertility, Female, ART
- Being tested
- ICSI, IVF
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICSIProcedure or surgery
Also called Intracytoplasmic Sperm Injection
A technique that involves microinjection of spermatozoa into mature oocytes.
IVFProcedure or surgery
Also called in vitro fertilization
A process of fertilisation where an an egg is combined with sperm outside the body, in vitro.
| Study group | Role | What they receive |
|---|---|---|
| IVF | Experimental | embryos are cultured using conventional in vitro fertilization.A maximum of 2 embryos will be transferred for each treatment cycle. Receives: Procedure: IVF |
| ICSI | Experimental | embryos are fertilized using ICSI.A maximum of 2 embryos will be transferred for each treatment cycle. Receives: Procedure: ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
accumulated live birth rate
This will be based on the outcome of either the ICSI or the outcome of the IVF as will all other secondary outcomes
Measured: 42 weeks
Secondary outcomes (7)
Fertilization rate
Fertilization rate was defined as the percentage of fetal heart beat among total retrieved oocytes
Measured: 1 day after fertilization
Embryo quality
Embryo quality was evaluated by microscopy.
Measured: 3day after fertilization
clinical pregnancy rate
Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
Measured: 35 days after embryo transfer
implantation rate
Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.
Measured: 11-12 weeks after embryo transfer
biochemical pregnancy rate
Biochemical pregnancy was defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml.
Measured: 2 weeks after embryo transfer
pregnancy loss rate
Pregnancy loss is defined as any reason that resulted in failure of an embryo to develop, embryonic or fetal death, or spontaneous expulsion of a pregnancy.
Measured: 28 gestational weeks in maximum
ectopic pregnancy rate
Ectopic pregnancy is defined as an embryo implanted outside the uterine.
Measured: 12 gestational weeks in maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He-Feng Huang, International Peace Maternity and Child Health Hospital
- Investigators
- He-Feng Huang, MD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120884
- Sponsor's protocol ID
- IPMCH2017001
- Status last verified
- Apr 2017
- First submitted
- 16 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age
- ClinicalTrials.gov ID
- NCT03120884
- Acronym / sponsor ID
- IPMCH2017001
- Conditions
- Infertility, Female, ART
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,422 participants (estimated)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 19 Apr 2017 (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.
This will be a prospective, randomized (1:1 ratio) clinical trial for non-male factor infertility in advanced maternal age with or without intracytoplasmic sperm injection(ICSI). Qualified 1422 patients are randomized into either of two groups: group A will undergo conventional in-vitro fertilization(IVF)(711 cases), Group B will undergo intracytoplasmic sperm injection (ICSI) (711 cases). All participants will receive the same protocol for ovarian stimulation and standardized luteal phase support.
The target population will be patients with non-male factor infertility aged ≥38years with FSH ≤15. Women with other reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are excluded.
The randomization will take place before controlled ovarian stimulation by a computer randomization system. The accumulated live birth rate , pregnancy complications will be followed up by checking medical records and telephone calls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF | Experimental | Procedure: IVFembryos are cultured using conventional in vitro fertilization.A maximum of 2 embryos will be transferred for each treatment cycle. |
| ICSI | Experimental | Procedure: ICSIembryos are fertilized using ICSI.A maximum of 2 embryos will be transferred for each treatment cycle. |
Who may qualify
- Ages
- 38 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients ages ≥38 years old with FSH ≤15;
- Spouse with normal sperm analysis according to WHO fifth edition criteria(sperm parameter values: total sperm count of at least 39 million, concentration≥15 × 106/ml, total motility ≥40%, progressive motility ≥32%， strict morphology ≥4% normal forms)；
- Female patients who intended to undergo IVF and had signed a written consent form.
Key exclusion criteria (10 listed)
- More than three previous IVF cycles (including both failed cycles and cycles that ended in live births)
- Female patients with Ovulation dysfunction related disease, such as endometriosis, polycystic ovarian syndrome(tubal factors are not included); undiagnosed infertility; Female patients who have previously been diagnosed with a uterine abnormality such as a malformed uterus(uterus unicornis, septate uterus, duplex uterus or uterus bicomis), adenomyosis, submucous myoma or intrauterine adhesion;
- Spouse who have experienced recurrent spontaneous abortions (including biochemical pregnancy abortion), defined as three or more previous pregnancy losses;
- Patients or their partners with an abnormal chromosome karyotype not including chromosome polymorphisms, which mainly refer to the variants in the chromosomal heterochromatin region
- the use of donor oocytes or sperm;
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 |
|---|---|---|
| ICSIAlso: Intracytoplasmic Sperm InjectionA technique that involves microinjection of spermatozoa into mature oocytes. | Procedure or surgery | ICSI |
| IVFAlso: in vitro fertilizationA process of fertilisation where an an egg is combined with sperm outside the body, in vitro. | Procedure or surgery | IVF |
Primary outcome
accumulated live birth rate
Time frame: 42 weeks
This will be based on the outcome of either the ICSI or the outcome of the IVF as will all other secondary outcomes
7 secondary outcomes
Fertilization rate
Time frame: 1 day after fertilization
Embryo quality
Time frame: 3day after fertilization
clinical pregnancy rate
Time frame: 35 days after embryo transfer
implantation rate
Time frame: 11-12 weeks after embryo transfer
biochemical pregnancy rate
Time frame: 2 weeks after embryo transfer
pregnancy loss rate
Time frame: 28 gestational weeks in maximum
ectopic pregnancy rate
Time frame: 12 gestational weeks in maximum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Individual participant dataSharing planned: Undecided. 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. This study is not recruiting at the moment.
He-Feng Huang, MD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICSI and IVF in people with Infertility, Female and ART, run by International Peace Maternity and Child Health Hospital at 1 site 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Apr 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He-Feng Huang, MD (+86-21-18017310186, hefenghuang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accumulated live birth rate (time frame: 42 weeks). 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 19 Apr 2017.