Infertility FemalePhase 2NCT02848950
The Effect of Metformin on Fecundability in an ART(Assisted Reproductive Technology) Setting - the Correlation to Uterine Flows
A Phase 2 study testing Metformin in people with Infertility Female, run by The Baruch Padeh Medical Center, Poriya.
Trial summary
The basis for obesity's impact on reproduction is not well characterised and there is a controversy whether the key organ influenced by it are the ovaries or the uterus. Insulin sensitizers ameliorate insulin resistance in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility Female
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jul 2017
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: from 18-40 years old.
- BMI > 30
- Infertile women undergoing frozen-thawed embryo transfer in an ART setting
- Women with at least one Top graded embryo
- Normal uterine Doppler indices at time of recruitment.
Who cannot join
- Diabetes mellitus - uncontrolled.
- Hyperprolactinemia- uncontrolled.
- Hypothyroidism- uncontrolled.
- women who are already treated with Metformin
- women with endometrial factor as the cause for infertility
Trial locations and contacts
No sites are listed yet.
nora gorhad shabso, doctor contact
About this study
Official title: The Effect of Metformin on Fecundability in Obese Women Undergoing ART - the Correlation to Uterine Flow Parameters A Prospective Randomized Controlled Trial
The basis for obesity's impact on reproduction is not well characterised and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.
Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to determine if Metformin helps to increase fecundability by affecting the uterus in women undergoing ART. As a surrogate marker- flows in the uterus will be tested during the treatment.
Read the detailed description
Obesity has been long implicated in reduced reproductive potential and it has been shown to impair conception and implantation. However, the basis for this adverse effect is still obscure and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.
It is well established that insulin resistance is one of the main mechanisms of obesity's negative influences on the reproductive organs in females. Insulin sensitizers ameliorate insulin resistance in obese patients.
This study seeks to determine if Metformin ,an oral antidiabetic and insulin sensitizer, helps to increase fecundability by affecting the uterus in women undergoing frozen-thawed embryo transfer compared to the control group. As a surrogate marker- flows in the uterus will be tested during the treatment.
- Conditions
- Infertility Female
- Being tested
- Metformin
- Keywords
- Metformin, fecundability, uterine doppler
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called glucophage
Supplementation of the study group with Metformin till the day of pregnancy confirmation
| Study group | Role | What they receive |
|---|---|---|
| treatment | Active comparator | drug: metformin Receives: Drug: Metformin |
| control | No intervention | without metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
Measured: until the blood test for pregnancy, about 4-6 weeks
Secondary outcomes (3)
The changes in Doppler blood flow indices in both uterine arteries
Measured: until the blood test for pregnancy, about 4-6 weeks
endometrial thickness change measured by millimeters
Measured: until the blood test for pregnancy, about 4-6 weeks
Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows
Measured: until the blood test for pregnancy, about 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, nora gorhad, The Baruch Padeh Medical Center, Poriya
- Investigators
- JOHNNY YOUNIS, PEOFESSOR, Principal investigator, Head of Fertility unit, Poriya' Bar Ilan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848950
- Sponsor's protocol ID
- M.UTERUS.CTIL
- Status last verified
- Jul 2016
- First submitted
- 17 May 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metformin on Fecundability in Obese Women Undergoing ART - the Correlation to Uterine Flow Parameters A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02848950
- Acronym / sponsor ID
- M.UTERUS.CTIL
- Conditions
- Infertility Female
- Keywords
- Metformin, fecundability, uterine doppler
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 29 Jul 2016 (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 basis for obesity's impact on reproduction is not well characterised and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.
Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to determine if Metformin helps to increase fecundability by affecting the uterus in women undergoing ART. As a surrogate marker- flows in the uterus will be tested during the treatment.
Detailed description
Obesity has been long implicated in reduced reproductive potential and it has been shown to impair conception and implantation. However, the basis for this adverse effect is still obscure and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.
It is well established that insulin resistance is one of the main mechanisms of obesity's negative influences on the reproductive organs in females. Insulin sensitizers ameliorate insulin resistance in obese patients.
This study seeks to determine if Metformin ,an oral antidiabetic and insulin sensitizer, helps to increase fecundability by affecting the uterus in women undergoing frozen-thawed embryo transfer compared to the control group. As a surrogate marker- flows in the uterus will be tested during the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Active comparator | Drug: Metformindrug: metformin |
| control | No intervention | –without metformin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: from 18-40 years old.
- BMI > 30
- Infertile women undergoing frozen-thawed embryo transfer in an ART setting
- Women with at least one Top graded embryo
- Normal uterine Doppler indices at time of recruitment.
Key exclusion criteria (5 listed)
- Diabetes mellitus - uncontrolled.
- Hyperprolactinemia- uncontrolled.
- Hypothyroidism- uncontrolled.
- women who are already treated with Metformin
- women with endometrial factor as the cause for infertility
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 |
|---|---|---|
| MetforminAlso: glucophageSupplementation of the study group with Metformin till the day of pregnancy confirmation | Drug | treatment |
Primary outcome
pregnancy rate
Time frame: until the blood test for pregnancy, about 4-6 weeks
3 secondary outcomes
The changes in Doppler blood flow indices in both uterine arteries
Time frame: until the blood test for pregnancy, about 4-6 weeks
endometrial thickness change measured by millimeters
Time frame: until the blood test for pregnancy, about 4-6 weeks
Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows
Time frame: until the blood test for pregnancy, about 4-6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Infertility Female
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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.
nora gorhad shabso, doctor contact
JOHNNY YOUNIS, PEOFESSOR principal investigator
Head of Fertility unit, Poriya' Bar Ilan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Infertility Female, run by The Baruch Padeh Medical Center, Poriya.
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 5 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 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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 nora gorhad shabso, doctor (ngorhad@poria.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: until the blood test for pregnancy, about 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 29 Jul 2016.