InfertilityNCT03682614
Effect of Intrauterine Injection of HCG on Clinical Pregnancy Outcome in Repeated Implantation Failure Patients
A study testing HCG and culture medium in people with Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial summary
Repeated implantation failure（RIF） is a insurmountable bottleneck in assisted reproductive technology, many studies have considered that the cause of two-thirds of implantation failure is the decreased endometrial receptivity. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- HCG and culture medium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2018to 16 Oct 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 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- repeated implantation failure patients: ≥ 3 times IVF-embryo transfer failed to help pregnancy (biochemical or non-pregnant)
- age ≤36 years old
- normal histopathological stage (+5-7)
- endometrial NK cell <4.5%
- 0 endometrial CD138 positive cell
- natural cycle frozen embryo transfer
- frozen blastocysts (≥4BC) embryos ≥ 1
Who cannot join
- Scar uterus (diverticulum or incision false lumen after cesarean section)
- intrauterine adhesions
- untreated hydrosalpinx
- adenomyosis (endometrial displacement)
- endometritis
- uterine fibroids compress the endometrium
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410000
About this study
Official title: Effect of Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer on Clinical Pregnancy Outcome in Repeated Implantation Failure Patients With Normal Pathohistological Stage --Pilot Study
Repeated implantation failure（RIF） is a insurmountable bottleneck in assisted reproductive technology, many studies have considered that the cause of two-thirds of implantation failure is the decreased endometrial receptivity. After exclude some major local immune factors(NK,CD138 cells) and implantation window out of phase, There are still a part of patients infertile .Human chorionic gonadotropin (hCG) is an early pre-implantation signal molecule secreted by the embryo, it can promote endometrial proliferation, increase blood flow and promote embryonic adhesion and inhibit self-regulated apoptosis of trophoblast cells. Previous studies showed that: intrauterine injection of HCG before embryo transfer can improve clinical outcomes in IVF/Intracytoplasmic sperm injection(ICSI). But some studies found that the intrauterine injection of HCG can not significantly improve the success rate of blastocyst transfer, and the reason may be the intrauterine injection of HCG time is too late to significantly increase the implantation rate. Would ahead of intrauterine injection of HCG be more effective? Thus, the patients of repeated implantation frozen embryo cycle according to the random principle accepted two kinds of transplants ways: ①intrauterine injection of HCG before blastocyst transfer; ②blastocyst transfer. Try to understand whether intrauterine injection of HCG can significantly improve the clinical pregnancy rate of blastocyst transfer in repeated implantation failure patients.
- Conditions
- Infertility
- Being tested
- HCG, culture medium
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCGDrug
we will use the catheter to pass through the cervix, and after that, the experiment Group will accept 40 μl 500 IU HCG injection into the uterine cavity 2 days before the blastocyst transfer.
culture mediumOther
The placebo group will accept 40 μl of culture medium injection into the uterine cavity 2 days before the blastocyst transfer.
| Study group | Role | What they receive |
|---|---|---|
| HCG group | Experimental | All patients will accept HCG 500IU intrauterine injection 2 days before blastocyte transfer Receives: Drug: HCG |
| control group | Placebo comparator | All patients will accept same dose of culture medium intrauterine injection 2 days before blastocyte transfer Receives: Other: culture medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Measured: 28 days after blastocyst transfer
Secondary outcomes (4)
clinical implantation rate
Measured: 28 days after blastocyst transfer
ongoing pregnancy rate
Measured: 70 days after blastocyst transfer
ectopic pregnancy rate
Measured: within 3 months after blastocyst transfer
abortion rate
Measured: within 28 weeks after blastocyst transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start10 Dec 2018
- Primary completion18 Aug 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Gong, Doctor, Principal investigator, Reproductive and Genetic hospital of CITIC-xiangya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682614
- Sponsor's protocol ID
- P2018010
- Status last verified
- Nov 2019
- First submitted
- 18 Sep 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer on Clinical Pregnancy Outcome in Repeated Implantation Failure Patients With Normal Pathohistological Stage --Pilot Study
- ClinicalTrials.gov ID
- NCT03682614
- Acronym / sponsor ID
- P2018010
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 18 Aug 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 24 Sep 2018 (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.
Repeated implantation failure（RIF） is a insurmountable bottleneck in assisted reproductive technology, many studies have considered that the cause of two-thirds of implantation failure is the decreased endometrial receptivity. After exclude some major local immune factors(NK,CD138 cells) and implantation window out of phase, There are still a part of patients infertile .Human chorionic gonadotropin (hCG) is an early pre-implantation signal molecule secreted by the embryo, it can promote endometrial proliferation, increase blood flow and promote embryonic adhesion and inhibit self-regulated apoptosis of trophoblast cells. Previous studies showed that: intrauterine injection of HCG before embryo transfer can improve clinical outcomes in IVF/Intracytoplasmic sperm injection(ICSI). But some studies found that the intrauterine injection of HCG can not significantly improve the success rate of blastocyst transfer, and the reason may be the intrauterine injection of HCG time is too late to significantly increase the implantation rate. Would ahead of intrauterine injection of HCG be more effective? Thus, the patients of repeated implantation frozen embryo cycle according to the random principle accepted two kinds of transplants ways: ①intrauterine injection of HCG before blastocyst transfer; ②blastocyst transfer. Try to understand whether intrauterine injection of HCG can significantly improve the clinical pregnancy rate of blastocyst transfer in repeated implantation failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCG group | Experimental | Drug: HCGAll patients will accept HCG 500IU intrauterine injection 2 days before blastocyte transfer |
| control group | Placebo comparator | Other: culture mediumAll patients will accept same dose of culture medium intrauterine injection 2 days before blastocyte transfer |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- repeated implantation failure patients: ≥ 3 times IVF-embryo transfer failed to help pregnancy (biochemical or non-pregnant)
- age ≤36 years old
- normal histopathological stage (+5-7)
- endometrial NK cell <4.5%
- 0 endometrial CD138 positive cell
Key exclusion criteria (6 listed)
- Scar uterus (diverticulum or incision false lumen after cesarean section)
- intrauterine adhesions
- untreated hydrosalpinx
- adenomyosis (endometrial displacement)
- endometritis
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 |
|---|---|---|
| HCGwe will use the catheter to pass through the cervix, and after that, the experiment Group will accept 40 μl 500 IU HCG injection into the uterine cavity 2 days before the blastocyst transfer. | Drug | HCG group |
| culture mediumThe placebo group will accept 40 μl of culture medium injection into the uterine cavity 2 days before the blastocyst transfer. | Other | control group |
Primary outcome
clinical pregnancy rate
Time frame: 28 days after blastocyst transfer
4 secondary outcomes
clinical implantation rate
Time frame: 28 days after blastocyst transfer
ongoing pregnancy rate
Time frame: 70 days after blastocyst transfer
ectopic pregnancy rate
Time frame: within 3 months after blastocyst transfer
abortion rate
Time frame: within 28 weeks after blastocyst transfer
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 11 Jan 2022.
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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.
Fei Gong, Doctor principal investigator
Reproductive and Genetic hospital of CITIC-xiangya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCG and culture medium in people with Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya 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 7 inclusion and 6 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 11 Jan 2022. 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. Some participants in this study may receive a placebo. 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?
clinical pregnancy rate (time frame: 28 days after blastocyst transfer). 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 11 Jan 2022.