Polycystic Ovary SyndromeNCT02910817
Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese PCOS Women
A study testing Metformin in people with Polycystic Ovary Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight and obese women with PCOS. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The inclusion criteria restricted the patients to 39 years old with basal FSH < 10 IU/ml and normal TSH and prolacin.
Who cannot join
- Exclusion criteria were diabetes mellitus (excluded by GTT), renal or liver disease, associated male factor, documented tubal factor or pelvic adhesions, elevated 17 alfa hydroxyprogesterone level and FSH ≥10 IU/ml. We also excluded the women who started program or medications to reduce their weight and those who their partner has abnormal semen parameters according to the world health organization parameters (WHO, 2010)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese Polycystic Ovary Syndrome Women; A Quasi Experimental Study
RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight and obese women with PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Placebo
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
The metformin-treated group received metformin (1000 mg per day) with the start of controlled ovarian stimulation (COH) until the day of the pregnancy check.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Metformin-treated group | Experimental | 51 overweight and obese women (BMI>24) with PCOS underwent their first fresh autologous IVF-embryo transfer cycle Receives: Drug: Metformin |
| Placebo | Placebo comparator | A cohort of fifty-one cross matched PCOS women Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of retrieved oocytes
Measured: Two weeks Metformin treatment
Secondary outcomes (1)
Live birth rate
Measured: End of the pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Saber Thabet Abdalmageed, Assiut University
- Investigators
- Osama Abdalmageed, Principal investigator, Women health center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910817
- Sponsor's protocol ID
- obgy-115-2014
- Status last verified
- Nov 2017
- First submitted
- 9 Sep 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Abdalmageed OS, Farghaly TA, Abdelaleem AA, Abdelmagied AE, Ali MK, Abbas AM. Impact of Metformin on IVF Outcomes in Overweight and Obese Women With Polycystic Ovary Syndrome: A Randomized Double-Blind Controlled Trial. Reprod Sci. 2019 Oct;26(10):1336-1342. doi: 10.1177/1933719118765985. Epub 2018 Mar 25.
PubMed 29576001
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese Polycystic Ovary Syndrome Women; A Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT02910817
- Acronym / sponsor ID
- obgy-115-2014
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Sep 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.
RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight and obese women with PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin-treated group | Experimental | Drug: Metformin51 overweight and obese women (BMI>24) with PCOS underwent their first fresh autologous IVF-embryo transfer cycle |
| Placebo | Placebo comparator | Other: PlaceboA cohort of fifty-one cross matched PCOS women |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The inclusion criteria restricted the patients to 39 years old with basal FSH < 10 IU/ml and normal TSH and prolacin.
Key exclusion criteria (1 listed)
- Exclusion criteria were diabetes mellitus (excluded by GTT), renal or liver disease, associated male factor, documented tubal factor or pelvic adhesions, elevated 17 alfa hydroxyprogesterone level and FSH ≥10 IU/ml. We also excluded the women who started program or medications to reduce their weight and those who their partner has abnormal semen parameters according to the world health organization parameters (WHO, 2010)
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 |
|---|---|---|
| MetforminThe metformin-treated group received metformin (1000 mg per day) with the start of controlled ovarian stimulation (COH) until the day of the pregnancy check. | Drug | Metformin-treated group |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Total number of retrieved oocytes
Time frame: Two weeks Metformin treatment
1 secondary outcome
Live birth rate
Time frame: End of the pregnancy
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 14 Nov 2017.
- Derived from this study: PubMed 29576001Abdalmageed OS, Farghaly TA, Abdelaleem AA, Abdelmagied AE, Ali MK, Abbas AM. Impact of Metformin on IVF Outcomes in Overweight and Obese Women With Polycystic Ovary Syndrome: A Randomized Double-Blind Controlled Trial. Reprod Sci. 2019 Oct;26(10):1336-1342. doi: 10.1177/1933719118765985. Epub 2018 Mar 25.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovary Syndrome
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Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
Osama Abdalmageed principal investigator
Women health center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Polycystic Ovary Syndrome, run by Assiut University 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 1 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 14 Nov 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 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.
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?
Total number of retrieved oocytes (time frame: Two weeks Metformin treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910817, which also lists 1 linked publication.
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 14 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.