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| Name | Class |
|---|---|
| Istituto Clinico Humanitas | OTHER |
| IRCCS San Raffaele | OTHER |
| Istituti Clinici Zucchi | OTHER |
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Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still represent a demanding challenge for clinicians. It has classically been claimed that using higher dosages of gonadotropins may overcome the scarce ovarian responsiveness to hyper-simulation and increase the chances of success. However, scientific evidence supporting this view is scanty and costs are inevitably much higher. In this study, the investigators hypothesized that similar chances of pregnancy may be achieved with a mild stimulation using exclusively Clomiphene citrate (CC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High doses | Active Comparator | Administration of high doses of gonadotrophins to stimulate ovarian follicular growth |
|
| Clomid | Experimental | Administration of Clomiphene Citrate to obtain ovarian follicular growth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clomifene Citrate | Drug | 3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| live birth rate | general "Live birth rate" will be recorded at the end of the study when all participants have performed their In vitro Fertilization (IVF) treatment. Live birth rate per single patients will be recorded 4 weeks after embryo transfer when a intrauterine gestational sac is expected to be seen in case of pregnancy. | end of the study (28 months) |
| Measure | Description | Time Frame |
|---|---|---|
| ratio pregnancies/costs | at the end of the study the number of obtained pregnancies will be divided by the total costs of treatments in two groups. A cost in euros will be therefore estimated for every single pregnancy in both groups. | end of the study (28 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| guido ragni, md | Fondazione Ca' Granda Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Ca' Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17336650 | Background | Heijnen EM, Eijkemans MJ, De Klerk C, Polinder S, Beckers NG, Klinkert ER, Broekmans FJ, Passchier J, Te Velde ER, Macklon NS, Fauser BC. A mild treatment strategy for in-vitro fertilisation: a randomised non-inferiority trial. Lancet. 2007 Mar 3;369(9563):743-749. doi: 10.1016/S0140-6736(07)60360-2. | |
| 16239317 | Background |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002996 | Clomiphene |
| D007987 | Gonadotropin-Releasing Hormone |
| D017329 | Triptorelin Pamoate |
| C571801 | follitropin alfa |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| GnRH analog and recombinant human FSH | Drug | daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle and recombinant human FSH 450 IU/die from day 3. |
|
|
| Eijkemans MJ, Heijnen EM, de Klerk C, Habbema JD, Fauser BC. Comparison of different treatment strategies in IVF with cumulative live birth over a given period of time as the primary end-point: methodological considerations on a randomized controlled non-inferiority trial. Hum Reprod. 2006 Feb;21(2):344-51. doi: 10.1093/humrep/dei332. Epub 2005 Oct 20. |
| 23249758 | Derived | Ragni G, Levi-Setti PE, Fadini R, Brigante C, Scarduelli C, Alagna F, Arfuso V, Mignini-Renzini M, Candiani M, Paffoni A, Somigliana E. Clomiphene citrate versus high doses of gonadotropins for in vitro fertilisation in women with compromised ovarian reserve: a randomised controlled non-inferiority trial. Reprod Biol Endocrinol. 2012 Dec 18;10:114. doi: 10.1186/1477-7827-10-114. |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |