Infertility, FemaleNCT05225155
Effect of Prophylatic Use of Enoxaparin in Women Undergoing in Vitro Fertilization Treatment
An observational study of Infertility, Female and Thrombophilia, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial summary
Retrospective study designed to evaluate outcomes in patients undergoing assisted reproduction. Some of them had thrombophilia, and part of them was treated with enoxaparin, started on the day of embryo transfer, and the other part not. Women without thrombophilia formed the control group. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Female, Thrombophilia, Fertilization in Vitro
- What is being tested?
- Enoxaparin
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Feb 2015to 31 Aug 2019
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All included patients underwent in vitro fertilization (IVF) treatment with intracytoplasmic sperm injection (ICSI). Patients were initially submitted to controlled ovarian hyperstimulation under a short protocol with gonadotropins and GnRH antagonist. Women with laboratorial thrombophilia could be treated or not with enoxaparin according to her physician's decision. Women without detectable thrombophilia formed the control group.
Who may be able to join
- Women with female infertility or unexplained infertility
- Normal sperm analysis
Who cannot join
- Women who did not agree with in vitro fertilization techniques
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Assistencia Materno Infantil Lambert
Santo André, São Paulo, 09041000
About this study
Retrospective study designed to evaluate outcomes in patients undergoing assisted reproduction. Some of them had thrombophilia, and part of them was treated with enoxaparin, started on the day of embryo transfer, and the other part not. Women without thrombophilia formed the control group.
Read the detailed description
A retrospective study was performed to evaluate the results in 104 patients undergoing to assisted reproduction. Women without thrombophilia were included as controls (n=20), while women with thrombophilia were either treated with 40 mg daily of enoxaparin (treated group, n=54), initiated on the day of embryo transfer, and continued to the week 36 of gestation, or did not receive this medication (untreated group, n= 30).
- Conditions
- Infertility, Female, Thrombophilia, Fertilization in Vitro
- Being tested
- Enoxaparin
- Keywords
- female infertility, thrombophilia, enoxaparin, abortion, in vitro fertilization, low molecular weight heparin
- Medical subject headings
- Infertility, Female, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Women with thrombophilia were treated with 40 mg daily of enoxaparin (treated group), initiated on the day of embryo transfer, up to week 36 of gestation
| Study group | Role | What they receive |
|---|---|---|
| Control | Women without thrombophilia, submitted to in vitro fertilization techniques | |
| Untreated Thrombophilia | Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, without treatment with enoxaparin | |
| Treated Thrombophilia | Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, and treated with enoxaparin Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with detectable fetal heartbeat
A transvaginal ultrasound was performed for detection of fetal heartbeat
Measured: Day 28
Number of participants with detectable ongoing pregnancy
Ongoing pregnancy was detected by ultrasound at twelve weeks
Measured: Week 12
Number of participants who delivered a live baby
Live birth was considered delivery that resulted in at least one live born neonate
Measured: Week 36
Secondary outcomes (1)
Number of participants with biochemical gestation detected
Serum beta-HCG detected 14 days after embryo transfer
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start2 Feb 2015
- Primary completion30 Nov 2015
- Study completion31 Aug 2019
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciano de Melo Pompei', Faculdade de Medicina do ABC
- Investigators
- Luciano M Pompei, Study director, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225155
- Sponsor's protocol ID
- 41006620.0.0000.0082
- Status last verified
- Sep 2022
- First submitted
- 25 Jan 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD sharing was not approved yet by our ethical committee board
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylatic Use of Enoxaparin in Women Undergoing in Vitro Fertilization Treatment
- ClinicalTrials.gov ID
- NCT05225155
- Acronym / sponsor ID
- 41006620.0.0000.0082
- Conditions
- Infertility, Female, Thrombophilia, Fertilization in Vitro
- Keywords
- female infertility, thrombophilia, enoxaparin, abortion, in vitro fertilization, low molecular weight heparin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 4 Feb 2022 (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.
Retrospective study designed to evaluate outcomes in patients undergoing assisted reproduction. Some of them had thrombophilia, and part of them was treated with enoxaparin, started on the day of embryo transfer, and the other part not. Women without thrombophilia formed the control group.
Detailed description
A retrospective study was performed to evaluate the results in 104 patients undergoing to assisted reproduction. Women without thrombophilia were included as controls (n=20), while women with thrombophilia were either treated with 40 mg daily of enoxaparin (treated group, n=54), initiated on the day of embryo transfer, and continued to the week 36 of gestation, or did not receive this medication (untreated group, n= 30).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Women without thrombophilia, submitted to in vitro fertilization techniques |
| Untreated Thrombophilia | – | –Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, without treatment with enoxaparin |
| Treated Thrombophilia | – | Drug: EnoxaparinWomen with laboratorial thrombophilia, submitted to in vitro fertilization techniques, and treated with enoxaparin |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All included patients underwent in vitro fertilization (IVF) treatment with intracytoplasmic sperm injection (ICSI). Patients were initially submitted to controlled ovarian hyperstimulation under a short protocol with gonadotropins and GnRH antagonist. Women with laboratorial thrombophilia could be treated or not with enoxaparin according to her physician's decision. Women without detectable thrombophilia formed the control group.
Key inclusion criteria (2 listed)
- Women with female infertility or unexplained infertility
- Normal sperm analysis
Key exclusion criteria (1 listed)
- Women who did not agree with in vitro fertilization techniques
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 |
|---|---|---|
| EnoxaparinWomen with thrombophilia were treated with 40 mg daily of enoxaparin (treated group), initiated on the day of embryo transfer, up to week 36 of gestation | Drug | Treated Thrombophilia |
Primary outcome
Number of participants with detectable fetal heartbeat
Time frame: Day 28
A transvaginal ultrasound was performed for detection of fetal heartbeat
Number of participants with detectable ongoing pregnancy
Time frame: Week 12
Ongoing pregnancy was detected by ultrasound at twelve weeks
Number of participants who delivered a live baby
Time frame: Week 36
Live birth was considered delivery that resulted in at least one live born neonate
1 secondary outcome
Number of participants with biochemical gestation detected
Time frame: Day 14
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 10 Sep 2022.
- Individual participant dataSharing planned: Undecided. The IPD sharing was not approved yet by our ethical committee board
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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.
Luciano M Pompei study director
Faculdade de Medicina do ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Thrombophilia, run by Faculdade de Medicina do ABC at 1 site in Brazil.
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 2 inclusion and 1 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 10 Sep 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 Brazil. 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?
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?
Number of participants with detectable fetal heartbeat (time frame: Day 28). The study lists 3 primary outcomes in all. 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 10 Sep 2022.