InfertilityPhase 4NCT03120715
Pregnancy Outcome of Women Using Low Molecular Weight Heparin Before Frozen-thawed Embryo Transfer
A Phase 4 study testing estrogen, Low Molecular Weight Heparin and hCG in people with Infertility, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Embryo freezing is a technique used commonly to optimize the pregnancy rate in assisted reproduction techniques (ART). Hormone replacement therapy (HRT) regimen is applied to prepare endometrium for frozen embryo transfer (FET) commonly.At present, It is unclear whether preimplantation low molecular weight heparin… Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- estrogen, Low Molecular Weight Heparin and hCG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to 5 Sep 2017
- Phase
- Phase 4
- 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 20 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 20 to 43 years;
- Body mass index (BMI) between 19 kg/m2 and 25 kg/m2;
- At least one good quality D3 embryos for transfer;
- prepare endometrium by hormone replacement therapy(HRT)protocal;
- capable of giving informed consent.
Who cannot join
- Women or their partner with abnormal chromosome karyotype including chromosome polymorphism;
- Women diagnosed as uterus abnormality: malformed uterus (uterus unicorns, septate uterus, duplex uterus, uterus bicornis), adenomyosis, submucous myoma, intrauterine adhesion;
- Women who underwent unilateral ovariectomy or with history of ovarian tumor surgery ;
- infection factors: TORCH virus (including Toxoplasma virus, rubella virus, cytomegalovirus,herpes simplex infection),Chlamydia and Mycoplasma, etc;
- Endometriosis;
- Having hydrosalpinx ;
- Low molecular weight heparin contraindications: thrombocytopenia, hemophilia and other bleeding disorders, liver and kidney dysfunction, with a clear history of heparin allergy or allergic constitution, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Xin Chen, M.D, Ph.D, 8620-61641908, zhiduoxinrun@163.com
Xin Chen, M.D, Ph.D
About this study
Official title: Comparison of Clinical Pregnancy Rates Between Two Protocols, With or Without Low Molecular Weight Heparin Administration Before Frozen Embryo Transfer in Hormonal Replacement Cycles: a Prospective Randomized Controlled Trial
Embryo freezing is a technique used commonly to optimize the pregnancy rate in assisted reproduction techniques (ART). Hormone replacement therapy (HRT) regimen is applied to prepare endometrium for frozen embryo transfer (FET) commonly.At present, It is unclear whether preimplantation low molecular weight heparin (LMWH) improves live birth and pregnancy rates in subfertile women undergoing FET. The study is a prospective randomized controlled trial to compare the pregnancy outcomes of FET in hormonal replacement therapy(HRT) cycles with or without LMWH administration before implantation.
Read the detailed description
This study is a prospective randomized controlled trial. Patients undergoing FET in Center for Reproductive Medicine of Nanfang Hospital, Southern Medical University are recruited.
They are randomly allocated to be prepared for transfer by using HRT cycle, with(low molecular weight heparin-group B(group LMWH-B)) or without( non-low molecular weight heparin-group A(group NLMWH-A)) administration of low molecular weight heparin (LMWH) before frozen embryo transfer (FET).
Both groups use the same protocol of HRT-FET. The oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is <7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is >9 mm.In group NLMWH-A, If the endometrial thickness is greater than 9 mm, human chorionic gonadotropin (hCG)10000 IU will be administered via intramuscular injection. Then on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3). In group LMWH-B, If the endometrial thickness is greater than 9 mm, hCG 10000 IU will be administered via intramuscular injection. And low molecular weight heparin (LMWH) will be injected subcutaneously 4100 IU (WHO) every other day before FET. Then on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3).
This study was approved by the medicine ethics committee of Nanfang Hospital.
- Conditions
- Infertility
- Being tested
- estrogen, Low Molecular Weight Heparin, hCG, progesterone
- Keywords
- low molecular weight heparin (LMWH), frozen embryo transfer (FET), pregnancy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estrogenDrug
Also called estrodiol
The oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is <7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is >9 mm.
Low Molecular Weight HeparinDrug
Also called LMWH
If the endometrial thickness is greater than 9 mm, hCG 10000 IU will be administered via intramuscular injection.And low molecular weight heparin (LMWH) will be injected subcutaneously 4100 IU (WHO) every other day before FET.Then on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3).
hCGDrug
Also called Human Chorionic Gonadotropin
If the endometrial thickness is greater than 9 mm, Human Chorionic Gonadotropin（hCG） 10000 IU will be administered via intramuscular injection.
progesteroneDrug
on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3).
| Study group | Role | What they receive |
|---|---|---|
| NLMWH-A | Placebo comparator | non-low molecular weight heparin-group A(group NLMWH-A).Without administration of low molecular weight heparin (LMWH) before FET.The oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is <7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is >9 mm.If the endometrial thickness is greater than 9 mm, Human Chorionic Gonadotropin（hCG） 10000 IU will be administered via intramuscular injection.on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3). Receives: Drug: estrogen; Drug: hCG; Drug: progesterone |
| LMWH-B | Experimental | low molecular weight heparin-group B(group LMWH-B).With administration of low molecular weight heparin (LMWH) before FET.The oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is <7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is >9 mm.If the endometrial thickness is greater than 9 mm, Human Chorionic Gonadotropin（hCG） 10000 IU will be administered via intramuscular injection.on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3). Receives: Drug: estrogen; Drug: Low Molecular Weight Heparin; Drug: hCG; Drug: progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
The pregnancy rate will be evaluated in patients of each groups 4-6 weeks after embryo transfer.
Measured: 4-6 weeks
Secondary outcomes (3)
Implantation rate
Evaluation the implantation rate in patients of each groups 4-6 weeks after frozen embryo transfer
Measured: 4-6 weeks
Ongoing pregnancy
Evaluation the ongoing pregnancy by monitoring pregnant bursa and fetal heart through ultrasound in patients of each group 12 weeks after embryo transfer.
Measured: 12 weeks
miscarriage rate
12 weeks
Measured: Evaluation the miscarriage rate in patients of each group 12 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 posted19 Apr 2017
- Study start1 Jul 2016
- Primary completion30 Jun 2017 (estimated)
- Study completion5 Sep 2017 (estimated)
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.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Chen, M.D, Ph.D, Principal investigator, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120715
- Sponsor's protocol ID
- NFEC-2017-024
- Status last verified
- Apr 2017
- First submitted
- 5 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
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
- Comparison of Clinical Pregnancy Rates Between Two Protocols, With or Without Low Molecular Weight Heparin Administration Before Frozen Embryo Transfer in Hormonal Replacement Cycles: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03120715
- Acronym / sponsor ID
- NFEC-2017-024
- Conditions
- Infertility
- Keywords
- low molecular weight heparin (LMWH), frozen embryo transfer (FET), pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 5 Sep 2017 (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.
Embryo freezing is a technique used commonly to optimize the pregnancy rate in assisted reproduction techniques (ART). Hormone replacement therapy (HRT) regimen is applied to prepare endometrium for frozen embryo transfer (FET) commonly.At present, It is unclear whether preimplantation low molecular weight heparin (LMWH) improves live birth and pregnancy rates in subfertile women undergoing FET. The study is a prospective randomized controlled trial to compare the pregnancy outcomes of FET in hormonal replacement therapy(HRT) cycles with or without LMWH administration before implantation.
Detailed description
This study is a prospective randomized controlled trial. Patients undergoing FET in Center for Reproductive Medicine of Nanfang Hospital, Southern Medical University are recruited.
They are randomly allocated to be prepared for transfer by using HRT cycle, with(low molecular weight heparin-group B(group LMWH-B)) or without( non-low molecular weight heparin-group A(group NLMWH-A)) administration of low molecular weight heparin (LMWH) before frozen embryo transfer (FET).
Both groups use the same protocol of HRT-FET. The oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is <7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is >9 mm.In group NLMWH-A, If the endometrial thickness is greater than 9 mm, human chorionic gonadotropin (hCG)10000 IU will be administered via intramuscular injection. Then on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3). In group LMWH-B, If the endometrial thickness is greater than 9 mm, hCG 10000 IU will be administered via intramuscular injection. And low molecular weight heparin (LMWH) will be injected subcutaneously 4100 IU (WHO) every other day before FET. Then on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3).
This study was approved by the medicine ethics committee of Nanfang Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| NLMWH-A | Placebo comparator | Drug: estrogen, Drug: hCG, Drug: progesteronenon-low molecular weight heparin-group A(group NLMWH-A).Without administration of low molecular weight heparin (LMWH) before FET.The oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is <7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is >9 mm.If the endometrial thickness is greater than 9 mm, Human Chorionic Gonadotropin（hCG） 10000 IU will be administered via intramuscular injection.on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3). |
| LMWH-B | Experimental | Drug: estrogen, Drug: Low Molecular Weight Heparin, Drug: hCG, Drug: progesteronelow molecular weight heparin-group B(group LMWH-B).With administration of low molecular weight heparin (LMWH) before FET.The oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is <7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is >9 mm.If the endometrial thickness is greater than 9 mm, Human Chorionic Gonadotropin（hCG） 10000 IU will be administered via intramuscular injection.on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3). |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 20 to 43 years;
- Body mass index (BMI) between 19 kg/m2 and 25 kg/m2;
- At least one good quality D3 embryos for transfer;
- prepare endometrium by hormone replacement therapy(HRT)protocal;
- capable of giving informed consent.
Key exclusion criteria (7 listed)
- Women or their partner with abnormal chromosome karyotype including chromosome polymorphism;
- Women diagnosed as uterus abnormality: malformed uterus (uterus unicorns, septate uterus, duplex uterus, uterus bicornis), adenomyosis, submucous myoma, intrauterine adhesion;
- Women who underwent unilateral ovariectomy or with history of ovarian tumor surgery ;
- infection factors: TORCH virus (including Toxoplasma virus, rubella virus, cytomegalovirus,herpes simplex infection),Chlamydia and Mycoplasma, etc;
- Endometriosis;
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 |
|---|---|---|
| estrogenAlso: estrodiolThe oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is <7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is >9 mm. | Drug | LMWH-B, NLMWH-A |
| Low Molecular Weight HeparinAlso: LMWHIf the endometrial thickness is greater than 9 mm, hCG 10000 IU will be administered via intramuscular injection.And low molecular weight heparin (LMWH) will be injected subcutaneously 4100 IU (WHO) every other day before FET.Then on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3). | Drug | LMWH-B |
| hCGAlso: Human Chorionic GonadotropinIf the endometrial thickness is greater than 9 mm, Human Chorionic Gonadotropin（hCG） 10000 IU will be administered via intramuscular injection. | Drug | LMWH-B, NLMWH-A |
| progesteroneon the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3). | Drug | LMWH-B, NLMWH-A |
Primary outcome
Clinical pregnancy rate
Time frame: 4-6 weeks
The pregnancy rate will be evaluated in patients of each groups 4-6 weeks after embryo transfer.
3 secondary outcomes
Implantation rate
Time frame: 4-6 weeks
Ongoing pregnancy
Time frame: 12 weeks
miscarriage rate
Time frame: Evaluation the miscarriage rate in patients of each group 12 weeks after embryo transfer.
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
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Xin Chen, M.D, Ph.D principal investigator
Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing estrogen, Low Molecular Weight Heparin and hCG in people with Infertility, run by Nanfang Hospital, Southern Medical University 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 5 inclusion and 7 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xin Chen, M.D, Ph.D (8620-61641908, zhiduoxinrun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 4-6 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.