A Phase 4 interventional study of Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins in Anovulatory Infertility Related to Polycystic Ovary Syndrome, sponsored by University Magna Graecia. Status unknown at 3 sites in Italy. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-09.
Sponsored by University Magna Graecia · Phase 4, Interventional, and Treatment
Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Even if several first-step treatments have been proposed for anovulatory infertile PCOS patients, very few data are available in literature regarding the best integrated strategy. In fact, a single compound could be effective as first-step approach but not or less useful when integrated in a more complex strategy.
The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate.
All patients eligible will undergo baseline assessment consisting of antropometric, hormonal, and ultrasonographic assessments. Successively, patients enrolled will be allocated in three different strategies (strategy A, B, and C).
A total of 184 infertile PCOS patients per arm will be enrolled and treated with three different integrated strategies: clomiphene followed by clomiphene plus metformin followed by gonadotropins (strategy A); metformin followed by metformin plus clomiphene followed by gonadotropins(strategy B); and metformin plus clomiphene followed by gonadotropins(strategy C).
In all patients, the same regimen will be used to administered clomiphene, metformin, and gonadotropins.Both clomiphene and metformin will be administered at incremental doses in each case.Gonadotropins will be administrated to obtain a controlled ovarian stimulation using highly purified urinary FSH in a low-dose step-up protocol.
During the study, the clinical and reproductive outcomes, and adverse experiences will be evaluated in each woman.
75 studies on the registry are indexed under Anovulation; 7 are open to participants now.
This study's planned enrollment of 552 is above the median of 80 across 52 interventional studies indexed under Anovulation.
Browse Anovulation studies →University Magna Graecia is the lead sponsor of 75 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
clomiphene followed by clomiphene plus metformin followed by gonadotropins
Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins
metformin followed by metformin plus clomiphene followed by gonadotropins
Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins
metformin plus clomiphene followed by gonadotropins
Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins
Drug pages: Clomiphene · Metformin · Gonadotropins
Multiple pregnancy rate
Time frame: 9 months
Ovulation rate
Time frame: 15 months
Pregnancy rate
Time frame: 15 months
Abortion rate
Time frame: 15 months
Live-birth rate
Time frame: 24 months
Adverse-events
Time frame: 15
The record gives a start of Jan 2007 and a primary completion of Dec 2015. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Clomiphene · Metformin · Gonadotropins
University Magna Graecia