An interventional study of Clomiphane citrate + Metformin and clomiphene citrate alone in Polycystic Ovary Syndrome (PCOS), Anovulatory Infertility, sponsored by Independent University Hospital, Pakistan. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Independent University Hospital, Pakistan · Not applicable, Interventional, and Treatment
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.
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.
975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.
This study's enrollment of 218 is above the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →This is the only study on the registry with Independent University Hospital, Pakistan as lead sponsor.
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Exclusion Criteria:
Use of metformin or clomiphene citrate within the preceding 3 months.
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.
Drug: Clomiphane citrate + Metformin
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.
Drug: clomiphene citrate alone
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 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.
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.
Time frame: Within 6 months of treatment
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2025 to primary completion in Jun 2025, 5 months.
Of 206 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's 5 months is below that.
Counting every sponsor, half of 221 studies reached it within 18 months; a quarter within 7 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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