Embryo ImplantationPhase 2NCT02072291
Nifedipine Treatment on Uterine Contractility in IVF
A Phase 2 study testing Nifedipine in people with Embryo Implantation, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The main factors associated with pregnancy rate in In Vitro Fertilization (IVF) treatment are embryo quality and the uterine ability to accept the embryo for implantation. This ability is influenced by uterine contractions (UC), which change in pattern and direction during the menstrual cycle. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Embryo Implantation
- What is being tested?
- Nifedipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to Jun 2018
- Phase
- Phase 2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient undergoing frozen embryo transfer
Who cannot join
- Body mass index (BMI) > 38 kg/m2
- Early follicular phase (day 2-4) serum follicle stimulating hormone (FSH) level > 20 mIU/ml.
- Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
- Any contraindication to being pregnant and carrying a pregnancy to term.
- Contraindication for the use of nifedipine, Estrogen and Progesterone suppositories.
- Patient treating with other drugs that interact with cytochrome P450 activity: azole antifungals, cimetidine, cyclosporine, erythromycin, quinidine, terfenadine, warfarin, benzodiazepines, flecainide, imipramine, propafenone and theophylline.
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- Irregular heart beat or already being treated with another medication for high blood pressure.
- Any ovarian or abdominal abnormality that may interfere with adequate transvaginal sonography (TVS) evaluation.
- Administration of any investigational drugs within three months prior to study enrollment.
- Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study.
- Unwillingness to give written informed consent. Previous entry into this study or simultaneous participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: The Influence of Nifedipine Treatment on Uterine Contractility During Frozen Embryo Transfer
The main factors associated with pregnancy rate in In Vitro Fertilization (IVF) treatment are embryo quality and the uterine ability to accept the embryo for implantation. This ability is influenced by uterine contractions (UC), which change in pattern and direction during the menstrual cycle. An abnormal uterine contraction pattern can displace the embryo from the proper position in the uterine cavity towards the cervix or the fallopian tubes and as a result may decrease pregnancy rates and increase the risk of ectopic pregnancy. Indeed, previous studies demonstrated a negative correlation between uterine contraction rate and implantation/pregnancy rates. Suppression of uterine contractions during embryo transfer can be achieved by a large array of drugs, such as cyclo-oxygenase inhibitors, β2-adrenoreceptor agonists, calcium-channel blockers, phosphodiesterase inhibitors and oxytocin antagonists. The objective of this study is to evaluate the efficacy of Nifedipine administration in reducing uterine contractility during IVF-frozen embryo transfer (FET) treatment.
- Conditions
- Embryo Implantation
- Being tested
- Nifedipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NifedipineDrug
PO Nifedipine 5mg single dose
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Experimental | Nifedipine 5mg single dose Receives: Drug: Nifedipine |
| Placebo | Placebo comparator | Not described Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
uterine contractility after treatment
Uterine contractility will be measured by vaginal ultrasound before and 30 minutes after treatment with Nifedipine or placebo
Measured: 30 minutes after treatment
Secondary outcomes (1)
Implantation and pregnancy rates
Rates of implantation and clinical pregnancy (cardiac activity) after treatment against placebo
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 posted26 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo ImplantationStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Assaf Ben-Meir, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072291
- Sponsor's protocol ID
- Nifedipine-FET
- Status last verified
- Feb 2017
- First submitted
- 24 Feb 2014
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Nifedipine Treatment on Uterine Contractility During Frozen Embryo Transfer
- ClinicalTrials.gov ID
- NCT02072291
- Acronym / sponsor ID
- Nifedipine-FET
- Conditions
- Embryo Implantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 26 Feb 2014 (estimated)
- 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.
The main factors associated with pregnancy rate in In Vitro Fertilization (IVF) treatment are embryo quality and the uterine ability to accept the embryo for implantation. This ability is influenced by uterine contractions (UC), which change in pattern and direction during the menstrual cycle. An abnormal uterine contraction pattern can displace the embryo from the proper position in the uterine cavity towards the cervix or the fallopian tubes and as a result may decrease pregnancy rates and increase the risk of ectopic pregnancy. Indeed, previous studies demonstrated a negative correlation between uterine contraction rate and implantation/pregnancy rates. Suppression of uterine contractions during embryo transfer can be achieved by a large array of drugs, such as cyclo-oxygenase inhibitors, β2-adrenoreceptor agonists, calcium-channel blockers, phosphodiesterase inhibitors and oxytocin antagonists. The objective of this study is to evaluate the efficacy of Nifedipine administration in reducing uterine contractility during IVF-frozen embryo transfer (FET) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | Experimental | Drug: NifedipineNifedipine 5mg single dose |
| Placebo | Placebo comparator | Drug: Nifedipine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient undergoing frozen embryo transfer
Key exclusion criteria (11 listed)
- Body mass index (BMI) > 38 kg/m2
- Early follicular phase (day 2-4) serum follicle stimulating hormone (FSH) level > 20 mIU/ml.
- Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
- Any contraindication to being pregnant and carrying a pregnancy to term.
- Contraindication for the use of nifedipine, Estrogen and Progesterone suppositories.
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 |
|---|---|---|
| NifedipinePO Nifedipine 5mg single dose | Drug | Nifedipine, Placebo |
Primary outcome
uterine contractility after treatment
Time frame: 30 minutes after treatment
Uterine contractility will be measured by vaginal ultrasound before and 30 minutes after treatment with Nifedipine or placebo
1 secondary outcome
Implantation and pregnancy rates
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
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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.
Assaf Ben-Meir, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nifedipine in people with Embryo Implantation, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 11 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 1 Mar 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Assaf Ben-Meir, MD (972-2-6776425, assaf.benmeir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uterine contractility after treatment (time frame: 30 minutes after treatment). 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 1 Mar 2017.