InfertilityEarly Phase 1NCT03681197
Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility
A Early Phase 1 study testing Metformin and Clomiphene Citrate in people with Infertility, run by Elham Raafat at 1 site in Egypt.
Trial summary
The aim of this study is to asses the effect of metformin on clinical pregnancy rate in women with unexplained infertility (randomized controlled trial). This study will be conducted in infertility clinic,Ain Shams university maternity hospital,170 women with unexplained infertility will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Metformin and Clomiphene Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2018to May 2019
- Phase
- Early Phase 1
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-35 years old.
- BMI 20-<30
- FSH 12 IU/L or less
- Normal transvaginal ulterasound(normal uterus and ovaries with no congenital anomalies).
- Patent fallopian tubes assesd by hysterosalpingogram or laparoscopy.
- Normal semen analysis.
- Infertile women with history of previous failed induction cycle.
Who cannot join
- Women younger than 20 or elder than 35 years old.
- Women with BMI equal to or more than 30.
- Uncorrected congenital or acquired uterine anomaly.
- Other causes of infertility rather than unexplained infertility.
- Patient with Diabetes Mellitus.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Elham Raafat Mohamed
Cairo
Elham R Mohamed, 0021156230921, Elhamraafat@outlook.com
About this study
The aim of this study is to asses the effect of metformin on clinical pregnancy rate in women with unexplained infertility (randomized controlled trial).
This study will be conducted in infertility clinic,Ain Shams university maternity hospital,170 women with unexplained infertility will be enrolled in this study.
Statistical analysis of the data will be performed .
Read the detailed description
Metformin is usually used with induction regimen in patients with PCOS as it improves ovulation rate by direct effect on ovarian tissue,Metformin will be used in combination with clomiphene citrate in women with unexplained infertility with previous failed cycle to asses its efficacy on clinical pregnancy rate.
Study will be conducted in infertility clinic,Ain Shams university maternity hospital.Study population comprises women with unexplained infertility aged 20-35 years with total sample size of 170 who willbe randomized into two groups with 85 women in each group.
Group A:is case group who will receive metformin plus clomiphene citrate. Group B:is control group who will receive clomiphene citrate plus placebo. Metformin will be started at time of booking and will be continued till pregnancy is confirmed in a dose of 850 mg twice daily in form of tablet.
Vaginal ultrasound is done for all in day 2 to exclude presence of ovarian cyst and to identify normal appearance of ovaries,then folliculometry on day 9 followed by serial folliculometry every other day till reaching dominant follicle 18 mm or more where HCG intramuscular injection will be given in a dose of 10000 iu .
serum pregnancy test will be done after 16 days. Transvaginal ulterasound will be done on day 35.
- Conditions
- Infertility
- Being tested
- Metformin, Placebo, Clomiphene Citrate
- Keywords
- metformin,unexplained infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called glucophage
Metformin 850 mg tablet will be started twice daily immediately at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed.
PlaceboDrug
In placebo group,placebo will be strted twice daily at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed.
Clomiphene CitrateDrug
Also called Clomid
50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Metformin Group | Active comparator | Will receive metformin plus clomiphene citrate Receives: Drug: Metformin; Drug: Clomiphene Citrate |
| Placebo | Placebo comparator | Will receive placebo plus clomiphene citrate. Receives: Drug: Placebo; Drug: Clomiphene Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Diagnosis of pregnancy by transvaginal ulterasound
Measured: one cycle for each woman (28 days in average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start15 Jun 2018
- Primary completionApr 2019 (estimated)
- Study completionMay 2019 (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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elham Raafat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elham Raafat, Ain Shams University
- Investigators
- Sarah S Moawad, Lecturer, Study director, Ain Shams Maternity HospitalAhmed M Bahaa Eldin, Professor, Study director, Ain Shams Maternity HospitalHisham M Fathy, Professor, Study director, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681197
- Sponsor's protocol ID
- 1982
- Status last verified
- Mar 2019
- First submitted
- 13 Aug 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT03681197
- Acronym / sponsor ID
- 1982
- Conditions
- Infertility
- Keywords
- metformin,unexplained infertility
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Elham RaafatUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 21 Sep 2018 (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.
The aim of this study is to asses the effect of metformin on clinical pregnancy rate in women with unexplained infertility (randomized controlled trial).
This study will be conducted in infertility clinic,Ain Shams university maternity hospital,170 women with unexplained infertility will be enrolled in this study.
Statistical analysis of the data will be performed .
Detailed description
Metformin is usually used with induction regimen in patients with PCOS as it improves ovulation rate by direct effect on ovarian tissue,Metformin will be used in combination with clomiphene citrate in women with unexplained infertility with previous failed cycle to asses its efficacy on clinical pregnancy rate.
Study will be conducted in infertility clinic,Ain Shams university maternity hospital.Study population comprises women with unexplained infertility aged 20-35 years with total sample size of 170 who willbe randomized into two groups with 85 women in each group.
Group A:is case group who will receive metformin plus clomiphene citrate. Group B:is control group who will receive clomiphene citrate plus placebo. Metformin will be started at time of booking and will be continued till pregnancy is confirmed in a dose of 850 mg twice daily in form of tablet.
Vaginal ultrasound is done for all in day 2 to exclude presence of ovarian cyst and to identify normal appearance of ovaries,then folliculometry on day 9 followed by serial folliculometry every other day till reaching dominant follicle 18 mm or more where HCG intramuscular injection will be given in a dose of 10000 iu .
serum pregnancy test will be done after 16 days. Transvaginal ulterasound will be done on day 35.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Group | Active comparator | Drug: Metformin, Drug: Clomiphene CitrateWill receive metformin plus clomiphene citrate |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Clomiphene CitrateWill receive placebo plus clomiphene citrate. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 20-35 years old.
- BMI 20-<30
- FSH 12 IU/L or less
- Normal transvaginal ulterasound(normal uterus and ovaries with no congenital anomalies).
- Patent fallopian tubes assesd by hysterosalpingogram or laparoscopy.
Key exclusion criteria (5 listed)
- Women younger than 20 or elder than 35 years old.
- Women with BMI equal to or more than 30.
- Uncorrected congenital or acquired uterine anomaly.
- Other causes of infertility rather than unexplained infertility.
- Patient with Diabetes Mellitus.
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: glucophageMetformin 850 mg tablet will be started twice daily immediately at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed. | Drug | Metformin Group |
| PlaceboIn placebo group,placebo will be strted twice daily at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed. | Drug | Placebo |
| Clomiphene CitrateAlso: Clomid50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days | Drug | Metformin Group, Placebo |
Primary outcome
Clinical pregnancy rate
Time frame: one cycle for each woman (28 days in average)
Diagnosis of pregnancy by transvaginal ulterasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Sarah S Moawad, Lecturer study director
Ain Shams Maternity Hospital
Ahmed M Bahaa Eldin, Professor study director
Ain Shams Maternity Hospital
Hisham M Fathy, Professor study director
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin and Clomiphene Citrate in people with Infertility, run by Elham Raafat at 1 site in Egypt.
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 7 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 21 Mar 2019. 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 Egypt. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Elham R Mohamed (0021156230921, Elhamraafat@outlook.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: one cycle for each woman (28 days in average)). 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 21 Mar 2019.