Recurrent Implantation FailureRIFNCT04118959
Role of Atosiban in Recurrent Implantation Failure
An observational study of Recurrent Implantation Failure, run by Al Baraka Fertility Hospital at 1 site in Bahrain.
Trial summary
ET is the final stage of IVF which independently influences the treatment outcome. Successful embryo implantation is dependent on uterine receptivity. Atosiban is a novel class of drug which is effective in priming the uterus for implantation. Read more about this study
- Who is it for?
- Ages 22 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Implantation Failure
- How many people
- 150 participants
- Where
- 1 siteBahrain
- Study dates
- 10 Oct 2019to 25 Nov 2021
- 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 22 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: those patients with a history of recurrent implantation failure
Who may be able to join
- Women 22-40 years age
- Body mass index- 18.5-30 kg/m 2
- The normal uterine cavity on ultrasound scan
- At least one good quality embryo present for transfer
- Endometrium thickness ≥7.5 mm with endometrial volume 2-2.5 ml and good endometrial and subendometrial vascularity.
Who cannot join
- 1. Women ≥ 40 years age 2. Uterine abnormalities that can compromise the IRs (e.g., endometrial polyp, fibroids, hydrosalpinx, and adenomyosis) 3. Patients at risk of ovarian hyperstimulation syndrome 4. Patients with a history of hypersensitivity to atosiban 5. Endocrine dysfunction 6. Major organ dysfunction such as liver or kidney failure.
Trial locations and contacts
1 site in 1 country.
Bahrain1 site, 1 recruiting
- Recruiting
Al-BARAKA FERTILITY HOSPITAL
Adliya, Manama, 15006
AHMED BARAKAT, FRCOG, 0097336660500, ahmed_barakat@yahoo.com
Kamal Rageh, M.D, 0097333153871, dr_kamal_rageh@yahoo.com
About this study
Official title: The Value of Atosiban on the Day of Embryo Transfer in Patients With Recurrent Implantation Failure
ET is the final stage of IVF which independently influences the treatment outcome. Successful embryo implantation is dependent on uterine receptivity. Atosiban is a novel class of drug which is effective in priming the uterus for implantation. It reduces uterine contractions and increases endomyometrial perfusion, both of which have potential benefits regarding improved IRs, CPR, and ongoing pregnancy rates. Atosiban has a good embryonic safety profile. It has no systemic toxicity, no mutagenic effects, and no carcinogenic effects
Read the detailed description
ET is a critical step of an IVF cycle that merits the utmost attention. Its success depends on the frequency of uterine contractions, the endometrial receptivity and the quality of embryos transferred.
Uterine contractions are the most fundamental constituents of the uterine receptivity. Excessive contractions may decrease the implantation potential of embryos by expelling the embryos from the uterus. Studies have revealed a six-fold increase in uterine contractility in IVF cycles when measured before ET as compared to the condition before ovulation in natural cycles. Excessive manipulation of the cervix such as the use of tenaculum during difficult ET can also trigger uterine contractions, consequently leading to failure of embryo implantation.
IVF success rates have been potentially improved by the use of drugs that inhibit pronounced uterine contractions at the time of ET. Treatment strategies such as the use of beta-agonists or nonsteroidal anti-inflammatory agents for tocolysis have not been beneficial in IVF-ET procedures.
Atosiban is a combined oxytocin/vasopressin V1A antagonist. It functions mainly by blocking oxytocin and vasopressin V1a receptors to decrease the frequency and amplitude of uterine contractions, which enhances implantation and pregnancy rates. RIF remains unexplained in most cases, which results in considerable variation in how RIF is treated and managed. Atosiban competes with oxytocin at oxytocin receptors in endometrial cells and inhibits oxytocin-induced PGF2α release, thus inhibiting uterine contractions and increasing chances of embryo implantation and may add value in improving the outcome in RIF patients.
Recently published studies showed that atosiban inhibits oxytocin-induced PGF2α and uterine contractility, consequently leading to improved IRs. Studies have shown a considerable reduction in the frequency of uterine contractions before and after the administration of atosiban in women undergoing ET.
- Conditions
- Recurrent Implantation Failure
- Keywords
- Recurrent implantation failure, IVF, Atosiban, Embryo Transfer
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
B- HCG
Measured: 2 weeks
clinical pregnancy rate
positive fetal heart beats
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start10 Oct 2019
- Primary completion20 Nov 2021 (estimated)
- Study completion25 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Implantation FailureStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Baraka Fertility Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kamal Rageh, Al Baraka Fertility Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118959
- Sponsor's protocol ID
- K.Rageh
- Acronym
- RIF
- Status last verified
- Sep 2021
- First submitted
- 6 Oct 2019
- Last updated
- 28 Sep 2021
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Atosiban on the Day of Embryo Transfer in Patients With Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT04118959
- Acronym / sponsor ID
- RIF / K.Rageh
- Conditions
- Recurrent Implantation Failure
- Keywords
- Recurrent implantation failure, IVF, Atosiban, Embryo Transfer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Al Baraka Fertility HospitalUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 20 Nov 2021 (estimated)
- Study completion
- 25 Nov 2021 (estimated)
- First posted
- 8 Oct 2019 (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.
ET is the final stage of IVF which independently influences the treatment outcome. Successful embryo implantation is dependent on uterine receptivity. Atosiban is a novel class of drug which is effective in priming the uterus for implantation. It reduces uterine contractions and increases endomyometrial perfusion, both of which have potential benefits regarding improved IRs, CPR, and ongoing pregnancy rates. Atosiban has a good embryonic safety profile. It has no systemic toxicity, no mutagenic effects, and no carcinogenic effects
Detailed description
ET is a critical step of an IVF cycle that merits the utmost attention. Its success depends on the frequency of uterine contractions, the endometrial receptivity and the quality of embryos transferred.
Uterine contractions are the most fundamental constituents of the uterine receptivity. Excessive contractions may decrease the implantation potential of embryos by expelling the embryos from the uterus. Studies have revealed a six-fold increase in uterine contractility in IVF cycles when measured before ET as compared to the condition before ovulation in natural cycles. Excessive manipulation of the cervix such as the use of tenaculum during difficult ET can also trigger uterine contractions, consequently leading to failure of embryo implantation.
IVF success rates have been potentially improved by the use of drugs that inhibit pronounced uterine contractions at the time of ET. Treatment strategies such as the use of beta-agonists or nonsteroidal anti-inflammatory agents for tocolysis have not been beneficial in IVF-ET procedures.
Atosiban is a combined oxytocin/vasopressin V1A antagonist. It functions mainly by blocking oxytocin and vasopressin V1a receptors to decrease the frequency and amplitude of uterine contractions, which enhances implantation and pregnancy rates. RIF remains unexplained in most cases, which results in considerable variation in how RIF is treated and managed. Atosiban competes with oxytocin at oxytocin receptors in endometrial cells and inhibits oxytocin-induced PGF2α release, thus inhibiting uterine contractions and increasing chances of embryo implantation and may add value in improving the outcome in RIF patients.
Recently published studies showed that atosiban inhibits oxytocin-induced PGF2α and uterine contractility, consequently leading to improved IRs. Studies have shown a considerable reduction in the frequency of uterine contractions before and after the administration of atosiban in women undergoing ET.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- those patients with a history of recurrent implantation failure
Key inclusion criteria (5 listed)
- Women 22-40 years age
- Body mass index- 18.5-30 kg/m 2
- The normal uterine cavity on ultrasound scan
- At least one good quality embryo present for transfer
- Endometrium thickness ≥7.5 mm with endometrial volume 2-2.5 ml and good endometrial and subendometrial vascularity.
Key exclusion criteria (1 listed)
- 1. Women ≥ 40 years age 2. Uterine abnormalities that can compromise the IRs (e.g., endometrial polyp, fibroids, hydrosalpinx, and adenomyosis) 3. Patients at risk of ovarian hyperstimulation syndrome 4. Patients with a history of hypersensitivity to atosiban 5. Endocrine dysfunction 6. Major organ dysfunction such as liver or kidney failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pregnancy rate
Time frame: 2 weeks
B- HCG
clinical pregnancy rate
Time frame: 4 weeks
positive fetal heart beats
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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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.
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 Recurrent Implantation Failure, run by Al Baraka Fertility Hospital at 1 site in Bahrain.
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 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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 Bahrain. 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 Kamal eldin Rageh, M.D. (0097333153871, dr_kamal_rageh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: 2 weeks). The study lists 2 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 28 Sep 2021.