Polycystic Ovary Syndrome (PCOS), Anovulatory InfertilityCC-MET PCOS TNCT07872501
Clomiphene Citrate Alone Versus Clomiphene Plus Metformin as First Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome
A study testing Clomiphane citrate + Metformin and clomiphene citrate alone in people with Polycystic Ovary Syndrome (PCOS), Anovulatory Infertility, run by Independent University Hospital, Pakistan at 1 site in Pakistan.
Trial summary
This study will compare the effectiveness of clomiphene citrate alone with clomiphene citrate combined with metformin for treating anovulation and infertility in women with polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Anovulatory Infertility
- What is being tested?
- Clomiphane citrate + Metformin and clomiphene citrate alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 30 Jun 2025
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-40 years. Diagnosed with polycystic ovary syndrome (PCOS). Have infertility due to anovulation. Provide written informed consent to participate.
Who cannot join
- Pregnant or breastfeeding women. Contraindications to clomiphene citrate or metformin. Other significant medical or gynecological conditions contributing to infertility.
- Use of metformin or clomiphene citrate within the preceding 3 months.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Independent University Hospital
Faisalābad, Punjab Province, 38000
About this study
This study will compare the effectiveness of clomiphene citrate alone with clomiphene citrate combined with metformin for treating anovulation and infertility in women with polycystic ovary syndrome (PCOS). Women with PCOS who have difficulty becoming pregnant because they do not ovulate regularly will be enrolled in the study. Participants will be assigned to receive either clomiphene citrate alone or clomiphene citrate combined with metformin. The study will compare pregnancy and ovulation outcomes between the two treatment groups to determine whether adding metformin to clomiphene citrate improves the chances of conception in women with PCOS-related anovulatory infertility.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a common cause of anovulatory infertility in women of reproductive age. Irregular or absent ovulation can make it difficult for affected women to conceive. Clomiphene citrate is an established treatment used to induce ovulation in women with PCOS-related infertility. Metformin, an insulin-sensitizing medication, has also been used in women with PCOS and may improve metabolic and reproductive abnormalities associated with the condition.
This study is designed to compare clomiphene citrate alone with clomiphene citrate combined with metformin as a first-line treatment approach for anovulatory infertility associated with PCOS. The study will evaluate whether the addition of metformin to clomiphene citrate provides greater reproductive benefit than clomiphene citrate alone.
Eligible participants will be assigned to one of the two treatment groups according to the study protocol and will be followed during the treatment period. Reproductive outcomes will be assessed and compared between the groups.
The findings of this study may help determine whether adding metformin to clomiphene citrate improves treatment outcomes in women with PCOS-related anovulatory infertility and may provide evidence to support treatment decisions in this patient population.
- Being tested
- Clomiphane citrate + Metformin, clomiphene citrate alone
- Keywords
- PCOS; Anovulatory infertility; Anovulation; Ovulation induction; Clomiphene citrate; Metformin
- Medical subject headings
- Polycystic Ovary Syndrome, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphane citrate + MetforminDrug
Clomiphene citrate was administered as an ovulation-induction treatment, with dose escalation up to 150 mg/day according to the study protocol. It was administered alone in Group B and in combination with metformin in Group A. Participants were followed for six months, and conception was assessed using a urine pregnancy test.
clomiphene citrate aloneDrug
Clomiphene citrate was administered as an ovulation-induction treatment, with dose escalation up to 150 mg/day according to the study protocol. Participants received clomiphene citrate alone without metformin and were followed for six months. Conception was assessed using a urine pregnancy test.
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene Citrate + Metformin grp A | Experimental | Participants will receive clomiphene citrate 50 mg/day on the 2nd and 6th day, with the dose increased gradually up to 150 mg/day, along with metformin 500 mg three times daily. Participants will be followed for six months. Receives: Drug: Clomiphane citrate + Metformin |
| clomiphene citrate alone grp B | Experimental | Participants will receive clomiphene citrate 50 mg/day on the 2nd and 6th day, with the dose increased gradually up to 150 mg/day. Participants will not receive metformin and will be followed for six months. Receives: Drug: clomiphene citrate alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conception
Conception following ovulation-induction treatment, assessed by a urine pregnancy test. A positive urine pregnancy test was considered evidence of conception. The proportion of women achieving pregnancy was compared between the two treatment groups.
Measured: Within 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS), Anovulatory 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two parallel treatment groups: clomiphene citrate alone or clomiphene citrate combined with metformin. Participants will remain in their assigned treatment group throughout the study, and outcomes will be compared between the two groups.
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Independent University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahira Parveen, Independent University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872501
- Sponsor's protocol ID
- 000053
- Acronym
- CC-MET PCOS T
- Status last verified
- Jan 2025
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clomiphene Citrate Alone Versus Clomiphene Plus Metformin as First Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07872501
- Acronym / sponsor ID
- CC-MET PCOS T / 000053
- Keywords
- PCOS; Anovulatory infertility; Anovulation; Ovulation induction; Clomiphene citrate; Metformin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Independent University Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Oct 2026 (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.
This study will compare the effectiveness of clomiphene citrate alone with clomiphene citrate combined with metformin for treating anovulation and infertility in women with polycystic ovary syndrome (PCOS). Women with PCOS who have difficulty becoming pregnant because they do not ovulate regularly will be enrolled in the study. Participants will be assigned to receive either clomiphene citrate alone or clomiphene citrate combined with metformin. The study will compare pregnancy and ovulation outcomes between the two treatment groups to determine whether adding metformin to clomiphene citrate improves the chances of conception in women with PCOS-related anovulatory infertility.
Detailed description
Polycystic ovary syndrome (PCOS) is a common cause of anovulatory infertility in women of reproductive age. Irregular or absent ovulation can make it difficult for affected women to conceive. Clomiphene citrate is an established treatment used to induce ovulation in women with PCOS-related infertility. Metformin, an insulin-sensitizing medication, has also been used in women with PCOS and may improve metabolic and reproductive abnormalities associated with the condition.
This study is designed to compare clomiphene citrate alone with clomiphene citrate combined with metformin as a first-line treatment approach for anovulatory infertility associated with PCOS. The study will evaluate whether the addition of metformin to clomiphene citrate provides greater reproductive benefit than clomiphene citrate alone.
Eligible participants will be assigned to one of the two treatment groups according to the study protocol and will be followed during the treatment period. Reproductive outcomes will be assessed and compared between the groups.
The findings of this study may help determine whether adding metformin to clomiphene citrate improves treatment outcomes in women with PCOS-related anovulatory infertility and may provide evidence to support treatment decisions in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two parallel treatment groups: clomiphene citrate alone or clomiphene citrate combined with metformin. Participants will remain in their assigned treatment group throughout the study, and outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Clomiphene Citrate + Metformin grp A | Experimental | Drug: Clomiphane citrate + MetforminParticipants will receive clomiphene citrate 50 mg/day on the 2nd and 6th day, with the dose increased gradually up to 150 mg/day, along with metformin 500 mg three times daily. Participants will be followed for six months. |
| clomiphene citrate alone grp B | Experimental | Drug: clomiphene citrate aloneParticipants will receive clomiphene citrate 50 mg/day on the 2nd and 6th day, with the dose increased gradually up to 150 mg/day. Participants will not receive metformin and will be followed for six months. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 18-40 years. Diagnosed with polycystic ovary syndrome (PCOS). Have infertility due to anovulation. Provide written informed consent to participate.
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women. Contraindications to clomiphene citrate or metformin. Other significant medical or gynecological conditions contributing to infertility.
- Use of metformin or clomiphene citrate within the preceding 3 months.
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 |
|---|---|---|
| Clomiphane citrate + MetforminClomiphene citrate was administered as an ovulation-induction treatment, with dose escalation up to 150 mg/day according to the study protocol. It was administered alone in Group B and in combination with metformin in Group A. Participants were followed for six months, and conception was assessed using a urine pregnancy test. | Drug | Clomiphene Citrate + Metformin grp A |
| clomiphene citrate aloneClomiphene citrate was administered as an ovulation-induction treatment, with dose escalation up to 150 mg/day according to the study protocol. Participants received clomiphene citrate alone without metformin and were followed for six months. Conception was assessed using a urine pregnancy test. | Drug | clomiphene citrate alone grp B |
Primary outcome
Conception
Time frame: Within 6 months of treatment
Conception following ovulation-induction treatment, assessed by a urine pregnancy test. A positive urine pregnancy test was considered evidence of conception. The proportion of women achieving pregnancy was compared between the two treatment groups.
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 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clomiphane citrate + Metformin and clomiphene citrate alone in people with Polycystic Ovary Syndrome (PCOS), Anovulatory Infertility, run by Independent University Hospital, Pakistan at 1 site in Pakistan.
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 2 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 13 Oct 2026. 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 Pakistan. 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?
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?
Conception (time frame: Within 6 months of 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 13 Oct 2026.